Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410508
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-30
Brief Title:
Evaluation of a Brief Intervention to Improve Engagement in Early Intervention Services for Psychosis
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
Study Overview
Official Title:
Evaluation of a Brief Intervention to Improve Engagement and Recovery for At-risk Youth Enrolled in Early Intervention Services for Psychosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Negative experiences with healthcare prior to referral to early intervention services for psychosis EIS have been linked to poor engagement and clinical outcomes Recent research indicates that young adults who come to EIS services thru emergency departments urgent care or inpatient services have significantly greater rates of future use of these services as well as more negative perceptions of EIS and diminished engagement in treatment compared to young adults referred to EIS by other pathways These findings suggest a need for additional support to be provided to EIS patients especially those with prior negative healthcare experiences to maximize treatment engagement and outcomes A recent USA-based trial of a brief intervention addressing barriers to disengagement Just Do You including prior negative healthcare experiences showed promise in improving engagement and recovery This project seeks to adapt and evaluate the Just Do You intervention to a young adult early psychosis population in Nova Scotia The investigators aim to recruit young adults from the Nova Scotia Early Psychosis Program to engage in 2 psychotherapypsychoeducation sessions co-led by a clinician and peer support worker Following the intervention the investigators will measure improvements in participants engagement and recovery to determine the effectiveness of the program Outcomes between participants with negative prior healthcare experiences and those without will be compared to assess differential impact of the intervention for high-risk sub-groups This project has the potential to improve patients engagement in EIS care and enhance recovery outcomes for young adults
Detailed Description:
Background and rationale
For young adults experiencing early phase psychosis interactions with health services during initial help seeking are believed to be crucial in framing future attitudes towards healthcare and engagement in subsequent treatment Young adults experiencing psychosis often encounter significant adversity during initial help-seeking Delays to accessing suitable early intervention treatment are common and most young adults are referred to early intervention services for psychosis EIS via emergency and inpatient services while experiencing acute psychosis These referral experiences can involve law enforcement and involuntary hospitalization which are highly distressing for young adults especially in the context of first contact with services
In general psychiatric samples ie across diagnostic groups ages and phases of illness prior involuntary hospitalization is associated with negative views towards subsequent treatment with views of treatment as punitive and coercive rather than therapeutic and feelings of betrayal towards healthcare In addition in young adults experiencing early phase psychosis with prior hospitalization the prevalence of PTSD diagnosis is twice that of individuals without prior hospitalization with research attributing this increased prevalence to adversity specific to individuals prior experiences of healthcare Individuals experiencing early phase psychosis with comorbid PTSD often display diminished recovery and engagement in treatment While these outcomes alone are undesirable less is known about the relationship to between adverse experiences with healthcare and future engagement in EIS
Recent research at the Nova Scotia Early Psychosis Program NSEPP has shown a relationship between referral source to EIS and subsequent health care utilization when controlling for symptom severity and functioning participants referred to NSEPP from urgent services emergency inpatient and urgent care compared to those referred from GPs had a greater than 3-fold use of emergency and inpatient services 2 years following their acceptance to the NSEPP A related qualitative study further linked service users help-seeking and referral experiences to their perceptions towards EIS and engagement in treatment participants with previous experiences of inpatient hospitalization especially those experiencing involuntary hospitalization or interactions with law enforcement described increased adversity during healthcare interactions as well as diminished trust towards treatment providers confidence in the benefits of treatment and engagement in treatment Furthermore participants often cited past negative experiences with healthcare as explanations for these outcomes These results taken together suggest that many young adults referred to EIS especially those referred from urgent services are at risk for negative clinical outcomes including relapse which may be influenced by intermediate outcomes such as negative perceptions of EIS and decreased engagement in treatment As engagement in treatment is associated with improved symptomatic and functional outcomes this available research highlights the need for additional support to be provided to new patients in EIS in order to address potential negative perceptions towards healthcare and strengthen engagement in treatment which may predict long term clinical outcomes
A recent trial of a brief engagement intervention called Just Do You showed promise in addressing barriers to engagement and recovery for young adults with serious mental illness SMI and may be useful at the NSEPP This manualized intervention aimed to strengthen engagement in treatment by facilitating the processing of prior negative experiences with healthcare empowering participants to take leadership in recovery thus increasing participants buy-in towards treatment Additionally the Just Do You intervention was initially designed to be 2 sessions in length While more intensive psychotherapeutic interventions may provide additional benefit these are often more resource intensive and associated with increased difficulty with recruitment and maintaining participant engagement Considering these challenges a briefer intervention focused on bolstering engagement may be more feasible and cost-effective for a wider population
Despite the promising results of this initial trial and potential utility of this intervention key differences between the NSEPP and the services where Just Do You was implemented may detract from the suitability of this intervention in its current form Firstly this project was conducted in a different treatment setting New York and in a general young adult psychiatric sample which included but was not exclusive to those experiencing early phase psychosis who were likely to have less severe illness on average and differing treatment needs compared to an early phase psychosis population In addition as a facilitator of engagement during sessions the Just Do You intervention incorporated elements of music and art therapy modalities While these appeared efficacious in the initial study art and music therapy are specialized modalities that most settings including the NSEPP do not have resources or expertise to properly implement As a result the suitabilityfeasibility of this intervention for early psychosis populations young adults in CanadaNova Scotia is unclear This project aims to implement an adapted version of the Just Do You intervention at the NSEPP to strengthen engagement in treatment for recent referrals
Study Objectives
In fulfillment of these aims this project has 6 associated objectives described below
Primary Objectives Objective 1 Engage patient partners in adapting the Just Do You intervention to ensure its suitability and successful delivery at the NSEPP
Objective 2 Deliver tailored engagement intervention to recently accepted patients at the NSEPP
Objective 3 Evaluate the effectiveness of this intervention at improving patient reported measures of treatment engagement recovery and insight
Secondary Objectives
Objective 4 Explore trends in participants administrative health outcomes as a consequence of intervention including number of missed appointments emergency room visits and hospitalization for psychosis relapse
Objective 5 Compare trends in administrative outcomes following intervention for patients referred to EIS from urgent services to those referred to EIS from all other sources
Hypotheses
Based on past research conducted by at the Nova Scotia Early Psychosis Program and results from evaluations of the Just Do You intervention The investigators hypothesize that for participants in the treatment group this intervention will lead to i significant improvement in treatment engagement and recovery over the 3-month follow-up period Furthermore the investigators hypothesize that participation in the brief intervention will lead to significantly greater decreases in internalized stigma compared to non-participation over follow-up Additionally over 6 months from admission to EIS it is hypothesized that participants who receive the intervention will display iii reduction in missed appointments iv reduction in number of emergency room visits and inpatient hospitalizations and v greater improvements in engagement recovery and health outcomes as measured by effect size for those referred to EIS from urgent services compared to referrals from other sources following a sub-group analysis
Participant selection
All participants will be individuals aged 19 to 35 years old who are receiving services at NSEPP located at the Abbie J Lane hospital QEII Health Sciences Centre All participants will have a diagnosis of a psychotic disorder using the DSM-5 criteria for schizophrenia spectrum and other psychotic disorders eg schizophrenia schizoaffective disorder schizophreniform disorder unspecified schizophrenia spectrum and other psychotic disorder etc Psychotic disorders must have been diagnosed in the last 5 years to be eligible to receive services at NSEPP only those who have been accepted to NSEPP will be recruited
For the current study participants will be recruited within the first 3-12 months of treatment at the NSEPP The Just Do You engagement intervention was initially designed to be delivered within the first 4-weeks of participants treatment in order to maximize the potential long-term benefits of participants strengthened engagement in treatment However concerns have been raised that recruitment within the first four weeks of treatment at NSEPP may not be feasible with an early phase psychosis population who are likely to be experiencing more severe illness compared to those in the original Just Do You trial As a result the proposed recruitment timeline was determined in order to ensure recruitment procedures of the current study are as similar to those of the initial Just Do You intervention as is feasible While this recruitment timeline differs slightly from that of the original Just Do You trial results from this study support potential benefit of the engagement intervention when delivered after the initial 4-weeks of treatment Indeed authors reported that participants who received this intervention after the initial period 50 of overall sample showed no differences in improvement on outcomes compared to those who received the intervention prior As a result it was argued that this intervention may provide benefit even when delivered at various times in participants treatment
The investigators will be limiting study participation to those who are aged 19-35 Most early psychosis programs across the country have an age cap of 35 years old so this restriction is in line with current clinical practices The investigators aim to recruit 40 participants 20 controls and 20 intervention participants into the study The investigators do not anticipate any difficulties with this recruitment strategy as there are currently over 250 active patients at the NSEPP and the program accepts 50-70 new patients to the program each year The principal investigator a PhD student in clinical psychology or a research assistant will contact the potential participants via telephone or in person at the NSEPP to provide information about the study at that time and determine whether participants meet criteria for participation
Research Plan
Objective 1 Engaging patient partners in adapting the Just Do You intervention
The initial phase of this project involves active collaboration with patient partners in adapting the Just Do You intervention for suitable use in an early phase psychosis sample Adaptation of the existing intervention eg choosing suitable resourcesexercises to facilitate discussion around past treatment experiences will involve round table collaborative discussions with study personnel including the peer support worker and two members of the EPINS First Voice Advisory Group Discussions will first be centered around highlighting specific components of the initial Just Do You intervention and discussing intervention acceptability and feasibility of delivery As concerns may arise patient partners and study personnel will work collaboratively to modify intervention components to support intervention acceptability while ensuring modifications are consistent with theoretical and empirical underpinnings of the intervention During initial adaptation stages emphasis will be placed on actively engaging members of the EPINS First Voice Advisory Group who have had negative experiences with healthcare prior to engaging in EIS to ensure participants concerns are considered when adapting the Just Do You intervention It is anticipated that initial intervention adaptation will require a 9-12-hour commitment of each representative over 3 3- 4-hour initial meetings
Following adaptation of the intervention eligible clinicians and the peer support worker will be trained on delivering the intervention by a clinical psychology PhD student and a licensed clinical psychologist both of whom have experience working with this population and will be involved in initial adaptation of the Just Do You intervention Training will involve a full-day workshop lead by investigators which will include presentation of the intervention treatment targets underlying theory and role-play in delivering the intervention with clinicians and PSW Following training the investigators will begin delivery of the modified version of the Just Do You intervention to patients at the NSEPP
During implementation and delivery phase of the project study personnel will continue to meet with patient representatives once every two months at project steering committee meetings In these meetings patient representatives will be informed of any study updates and will collaborate with study investigators in finding solutions to encountered challenges including difficulties with intervention delivery or study recruitment Additionally when applicable in steering committee meetings patient partners and co-investigators will collaborate on reviewing and preparing relevant study material including ethics amendments consent forms and materials summarizing study findings to be shared with a broader audience As this project is anticipated to take 2-years to complete patient representatives will be required to attend 12 1-hour meetings with investigators in addition to the initial intervention adaptation meetings
Throughout patient engagement activities in this project The Public and Patient Engagement Evaluation Tool PPEET will be administered regularly once after each meeting to allow patient partners to provide regular feedback to research staff The PPEET is an evidence-based brief survey measure designed to gain patient partners assessments of engagement activities throughout the project Results from this measure will allow investigators to assess degree to which patient partners believe meaningful engagement in project processes has been achieved and results will be used on an ongoing basis to improve engagement processes during the study
Objectives 2 and 3 Delivering and evaluating the engagement intervention
Following adaptation of Just Do You delivery and evaluation of the intervention will begin A repeated measures quasi-experimental design will be used to evaluate the engagement interventions effectiveness This design is most suitable as randomization of participants to treatment or control may be unethical given existing evidence supporting the interventions effectiveness Consequently the investigators aim to approach all eligible patients within the first 3-12 months of treatment who have previously consented to being contacted for research purposes roughly 80 of overall patient population Eligible patients will be informed of the study protocolrationale as well as potential risks and benefits of participation in the intervention Following this eligible participants will choose between i full participation in the treatment group which involves engaging in the 2-part treatment intervention and completing study outcome assessments ii participation in the control group which involves completing outcome assessments during regular clinical visits without engaging in the intervention and iii refraining from participating in the study Following this those expressing interest in participating in either the treatment or control conditions will engage in a more in-depth consent discussion where additional specifics of participation will be outlined including risksbenefits confidentiality and the study protocol Individuals providing informed consent to participate in the study will then complete a baseline assessment This assessment includes completion of a demographic form which will include questions about participants age ethnicity migrant status gender identity and sexual orientation as well as questions about participants past experiences with mental healthcare and referral source In addition participants postal code will be collected and used to extrapolate an estimate of participants socioeconomic status SES using The Canadian Index of Multiple Deprivation CIMD This index developed by Statistics Canada uses postal code data to estimate individuals SES using participants geographical location on four dimensions Residential instability Economic dependency Ethno-cultural composition and Situational vulnerability These dimensions based on available evidence and up-to date census data and are widely used in Canadian health research as proxy multi-dimensional estimates of SES Collection of demographic data will allow investigators to better describe the participant sample and potentially allow for exploration of potential differential outcomes in minority communities
Participants will then complete a baseline clinical assessment which includes measures of engagement in treatment Yatchmenoff Client Engagement Scale self-reported recovery Recovery Assessment Scale psychotic symptom severity PANSS-6 global impression of illness severity Clinical CGI-I and -S Social and Occupational Functioning SOFAS illness insight SUMD current substance use WHO-ASSIST FC experiences of adverse and traumatic life events TALE and selfinternalized stigma ISMI These measures have all been validated and previously used in early psychosis populations The engagement and recovery measures were previously employed by investigators in the initial Just Do You trial and have been chosen to ensure comparability between studies
Intervention Procedure and Follow-up
Following baseline assessment participants receiving the intervention will engage in two intervention modules between 90-120 minutes each led by a clinician and PSW This intervention is based on the young adult framework for mental health and is informed by theories of health behaviour change and formal decision theory Targets of these sessions are common cognitive and affective barriers to engagement in mental health services for young adults especially those with past negative experiences with healthcare eg behavioural beliefs image impressions emotional reactions personal efficacy norms Following outlined practices and to reduce burden of participation participants will engage in the first module immediately following baseline assessment Module 1 will focus on discussions of the recovery process and principles of recovery while exploring stigma and participants perceptions and attitudes towards clinical service Module 2 which will be delivered 4-weeks following the first session will focus on processing prior difficult experiences with healthcare and psychosis and resulting perceptions towards treatment that commonly act as barriers to engagement Emphasis will be placed on instilling participants hope in recovery and building trust in current EIS
As the NSEPP largely provides care in person and study sessions are designed to coincide with participants regular treatment sessions at NSEPP Participants will be encouraged to complete the intervention modules in person However in order to increase accessibility to the intervention for participants who may have increased difficulty travelling to NSEPP participants will be given the option to attend sessions virtually through Zoom for Healthcare This interface has been carefully vetted by NS health for use with patients and is deemed to be the most secure virtual method to ensure patientparticipant privacy and security In addition to a baseline assessment treatment and control groups will complete follow up measures of participants self reported recovery and engagement outcomes 2 and 4-weeks following initial study enrollment Finally participants in the treatment group will complete assessment measures 3-months post-delivery of second session and control participants will complete measures 4-months following enrollment At final assessment participants PANSS-6 CGI-I SOFAS SUMD WHO-ASSIST and ISMI-9 scores will be measured in addition to participants recovery RAS and engagement scores Yatchmenoff client engagement scale Based on preference participants will be provided the option to complete self report measures at follow-up times either in person at the NSEPP or virtually Those electing to complete follow-up measures through REDCap will be invited by email to complete the web-based self-report measures De-identified data will be automatically entered into the secure web-based REDCap database capture platform with only participant ID approved by NS Health and managed in accordance with provincial privacy standards For participants electing to complete measures virtually clinician rated assessments will be completed in person at the NSEPP or completed virtually via Zoom for healthcare for NSHealth Completion of the above protocol will translate to a total length of follow up of 4 months for all participants
Objectives 4 and 5 Monitoring administrative health outcomes
In addition to evaluating effectiveness of the intervention by administering the above outcomes administrative health data will be used to explore intervention impact on participants high level clinical outcomes Firstly to obtain an additional objective indicator of participants treatment engagement the investigators will measure participants rate of missed appointments 3-months prior and 6-months following intervention In addition the investigators will measure rate of hospitalization and ER visits over the same time cumulative of visitsperson-year As the investigators have prior ethics approval to monitor high level demographic and outcome data for all NSEPP patients including those accepted to treatment who never engaged in EIS the investigators will use all past and present patients who did not receive the intervention as a comparison group and measure participants administrative health outcomes over the same timeline Finally outcomes for participants referred to NSEPP from urgent services will be compared to those of participants referred from other services to assess differential effectiveness of the intervention in previously identified high-risk groups
Data analysis plan
The goal of this project is to adapt the Just Do You intervention for use at NSEPP and deliver and evaluate the effectiveness of this intervention In accordance with the stated objectives and consistent with the initial Just Do You trial the investigators will measure changes in participants engagement recovery insight stigma and symptoms over follow-up and compare changes on these outcomes between control and active participants To address this first hypothesis - that participants who engaged in the intervention will show greater improvements in engagement self-reported recovery and insight compared to those in the control condition the investigators will use linear mixed regression models which are most suitable for repeated measures designs Potential differences in overall illness severity CGI-S PANSS-6 SOFAS WHO-ASSIST between control and treatment groups at baseline will be assessed using independent t-tests If significant differences on these measures are observed between groups baseline scores on these outcomes will be included as predictors in analyses in addition to treatment group The investigators aim to recruit 40 participants 20 controls and 20 intervention participants into the study This sample size was calculated to ensure 80 power of detecting the minimum effect size previously reported in the trial of the Just Do You intervention Cohens D ranged from 050 to 115 This sample is feasible given the clinics large patient pool 250 active patients 50 -70 new admissionsyear and the nature of research at NSEPP being embedded into clinical practice To measure impact of the intervention on participants self reported engagement recovery and insight the investigators will use linear mixed regression models which are suitable for repeated measures designs
To address the second and third hypotheses in fulfillment of study objectives 4 and 5 - that those receiving the study intervention will show a trend of fewer overall emergency department visits and hospitalizations for mental health reasons as well as fewer missed treatment appointments compared to those who received treatment as usual Poisson regression models will be used To assess for trends in rate of missed appointments hospitalization and ER visits and to compare potential differential outcomes for those referred to EIS via urgent or non-urgent sources both treatment group and referral source ie urgent vs non-urgent referral will be included as predictors in analyses using time of follow up as an offset variable in analysis If after reviewing the distribution of hospitalizations Poisson regression does not fit the data well ie data are over dispersed or are characterized by considerable proportion of sample not having urgent care visits modified Poisson regression can be used If the sample variance is significantly greater than the mean number of outcomes negative binomial regression will be used to account for this extra variance If data are skewed towards zero hospitalizations A zero inflated Poisson model will be used
Due to the small sample size 20 active participants and 20 controls with potential to include roughly 500 additional retrospective controls the investigators may not be adequately powered to detect small differences in administrative health outcomes between participant groups or include additional important demographic and clinical variables in analyses Nonetheless as this is a pilot project the investigators will assess and to report observed trends in health outcomes which are anticipated to act as preliminary proof of concept findings supporting potential subsequent follow-up studies It is the investigators aim that these initial study findings will facilitate potential follow-up studies evaluating this intervention that are adequately powered to detect differences in administrative health outcomes while control for additional potential confounders
To address the fourth hypothesis - That participants with past urgent service referral will benefit more from the intervention than those referred from other sources eg GP familyself Community mental health Subgroup comparisons will be conducted The overall effect size attributable to the intervention measured with Cohens D will be compared between participants with urgent vs non urgent referral to EIS
Confidentiality
The principal investigator will keep a file that links participant ID numbers to names that will be password-protected and stored on a computer that is housed at the Abbie J Lane building The only location where identifying information will be kept will be on the secure computer at NSEPP this information will be kept in a password-protected file and will be accessible only to the principal investigator and supervising investigators if necessary Research assistants and the peer support worker will have access to the de-identified file that contains ID numbers and the remainder of participant information eg outcomes In addition to being in a locked room in the NSEPP The computer on which files will be stored is also encrypted to prevent a breach of confidentiality should the computer be lost or stolen Potential participants contact information and information regarding date of acceptance to the NSEPP will be taken from the NSEPP clinic database of those participants who gave prior consent to the clinic to release this information for research purposes limiting the need to gain access to the potential participants health record Completed measures either paper and pencil or virtually through REDCap will be stored only with the date and unique participant ID number names or other identifying information will not be used Paper questionnaires will be kept separately each in a separate locked filing cabinet in a locked room with limited access Participant ID number and identifying information will be linked only through the password-protected file located on the principal investigators computer housed at the NSEPP Consent forms will be stored under lock and key in the principal investigators office at Abbie J Lane as will study data stored in a separate locked filing cabinet Seven years following the publication of the study results all data will be destroyedpermanently erased as required by the Nova Scotia Health Authority The records on the principal investigators computer will be permanently erased by the principal investigator with the assistance of IT and the physical records at the Abbie J Lane hospital will also be destroyed by the PI
For young adults experiencing early phase psychosis interactions with health services during initial help seeking are believed to be crucial in framing future attitudes towards healthcare and engagement in subsequent treatment Young adults experiencing psychosis often encounter significant adversity during initial help-seeking Delays to accessing suitable early intervention treatment are common and most young adults are referred to early intervention services for psychosis EIS via emergency and inpatient services while experiencing acute psychosis These referral experiences can involve law enforcement and involuntary hospitalization which are highly distressing for young adults especially in the context of first contact with services
In general psychiatric samples ie across diagnostic groups ages and phases of illness prior involuntary hospitalization is associated with negative views towards subsequent treatment with views of treatment as punitive and coercive rather than therapeutic and feelings of betrayal towards healthcare In addition in young adults experiencing early phase psychosis with prior hospitalization the prevalence of PTSD diagnosis is twice that of individuals without prior hospitalization with research attributing this increased prevalence to adversity specific to individuals prior experiences of healthcare Individuals experiencing early phase psychosis with comorbid PTSD often display diminished recovery and engagement in treatment While these outcomes alone are undesirable less is known about the relationship to between adverse experiences with healthcare and future engagement in EIS
Recent research at the Nova Scotia Early Psychosis Program NSEPP has shown a relationship between referral source to EIS and subsequent health care utilization when controlling for symptom severity and functioning participants referred to NSEPP from urgent services emergency inpatient and urgent care compared to those referred from GPs had a greater than 3-fold use of emergency and inpatient services 2 years following their acceptance to the NSEPP A related qualitative study further linked service users help-seeking and referral experiences to their perceptions towards EIS and engagement in treatment participants with previous experiences of inpatient hospitalization especially those experiencing involuntary hospitalization or interactions with law enforcement described increased adversity during healthcare interactions as well as diminished trust towards treatment providers confidence in the benefits of treatment and engagement in treatment Furthermore participants often cited past negative experiences with healthcare as explanations for these outcomes These results taken together suggest that many young adults referred to EIS especially those referred from urgent services are at risk for negative clinical outcomes including relapse which may be influenced by intermediate outcomes such as negative perceptions of EIS and decreased engagement in treatment As engagement in treatment is associated with improved symptomatic and functional outcomes this available research highlights the need for additional support to be provided to new patients in EIS in order to address potential negative perceptions towards healthcare and strengthen engagement in treatment which may predict long term clinical outcomes
A recent trial of a brief engagement intervention called Just Do You showed promise in addressing barriers to engagement and recovery for young adults with serious mental illness SMI and may be useful at the NSEPP This manualized intervention aimed to strengthen engagement in treatment by facilitating the processing of prior negative experiences with healthcare empowering participants to take leadership in recovery thus increasing participants buy-in towards treatment Additionally the Just Do You intervention was initially designed to be 2 sessions in length While more intensive psychotherapeutic interventions may provide additional benefit these are often more resource intensive and associated with increased difficulty with recruitment and maintaining participant engagement Considering these challenges a briefer intervention focused on bolstering engagement may be more feasible and cost-effective for a wider population
Despite the promising results of this initial trial and potential utility of this intervention key differences between the NSEPP and the services where Just Do You was implemented may detract from the suitability of this intervention in its current form Firstly this project was conducted in a different treatment setting New York and in a general young adult psychiatric sample which included but was not exclusive to those experiencing early phase psychosis who were likely to have less severe illness on average and differing treatment needs compared to an early phase psychosis population In addition as a facilitator of engagement during sessions the Just Do You intervention incorporated elements of music and art therapy modalities While these appeared efficacious in the initial study art and music therapy are specialized modalities that most settings including the NSEPP do not have resources or expertise to properly implement As a result the suitabilityfeasibility of this intervention for early psychosis populations young adults in CanadaNova Scotia is unclear This project aims to implement an adapted version of the Just Do You intervention at the NSEPP to strengthen engagement in treatment for recent referrals
Study Objectives
In fulfillment of these aims this project has 6 associated objectives described below
Primary Objectives Objective 1 Engage patient partners in adapting the Just Do You intervention to ensure its suitability and successful delivery at the NSEPP
Objective 2 Deliver tailored engagement intervention to recently accepted patients at the NSEPP
Objective 3 Evaluate the effectiveness of this intervention at improving patient reported measures of treatment engagement recovery and insight
Secondary Objectives
Objective 4 Explore trends in participants administrative health outcomes as a consequence of intervention including number of missed appointments emergency room visits and hospitalization for psychosis relapse
Objective 5 Compare trends in administrative outcomes following intervention for patients referred to EIS from urgent services to those referred to EIS from all other sources
Hypotheses
Based on past research conducted by at the Nova Scotia Early Psychosis Program and results from evaluations of the Just Do You intervention The investigators hypothesize that for participants in the treatment group this intervention will lead to i significant improvement in treatment engagement and recovery over the 3-month follow-up period Furthermore the investigators hypothesize that participation in the brief intervention will lead to significantly greater decreases in internalized stigma compared to non-participation over follow-up Additionally over 6 months from admission to EIS it is hypothesized that participants who receive the intervention will display iii reduction in missed appointments iv reduction in number of emergency room visits and inpatient hospitalizations and v greater improvements in engagement recovery and health outcomes as measured by effect size for those referred to EIS from urgent services compared to referrals from other sources following a sub-group analysis
Participant selection
All participants will be individuals aged 19 to 35 years old who are receiving services at NSEPP located at the Abbie J Lane hospital QEII Health Sciences Centre All participants will have a diagnosis of a psychotic disorder using the DSM-5 criteria for schizophrenia spectrum and other psychotic disorders eg schizophrenia schizoaffective disorder schizophreniform disorder unspecified schizophrenia spectrum and other psychotic disorder etc Psychotic disorders must have been diagnosed in the last 5 years to be eligible to receive services at NSEPP only those who have been accepted to NSEPP will be recruited
For the current study participants will be recruited within the first 3-12 months of treatment at the NSEPP The Just Do You engagement intervention was initially designed to be delivered within the first 4-weeks of participants treatment in order to maximize the potential long-term benefits of participants strengthened engagement in treatment However concerns have been raised that recruitment within the first four weeks of treatment at NSEPP may not be feasible with an early phase psychosis population who are likely to be experiencing more severe illness compared to those in the original Just Do You trial As a result the proposed recruitment timeline was determined in order to ensure recruitment procedures of the current study are as similar to those of the initial Just Do You intervention as is feasible While this recruitment timeline differs slightly from that of the original Just Do You trial results from this study support potential benefit of the engagement intervention when delivered after the initial 4-weeks of treatment Indeed authors reported that participants who received this intervention after the initial period 50 of overall sample showed no differences in improvement on outcomes compared to those who received the intervention prior As a result it was argued that this intervention may provide benefit even when delivered at various times in participants treatment
The investigators will be limiting study participation to those who are aged 19-35 Most early psychosis programs across the country have an age cap of 35 years old so this restriction is in line with current clinical practices The investigators aim to recruit 40 participants 20 controls and 20 intervention participants into the study The investigators do not anticipate any difficulties with this recruitment strategy as there are currently over 250 active patients at the NSEPP and the program accepts 50-70 new patients to the program each year The principal investigator a PhD student in clinical psychology or a research assistant will contact the potential participants via telephone or in person at the NSEPP to provide information about the study at that time and determine whether participants meet criteria for participation
Research Plan
Objective 1 Engaging patient partners in adapting the Just Do You intervention
The initial phase of this project involves active collaboration with patient partners in adapting the Just Do You intervention for suitable use in an early phase psychosis sample Adaptation of the existing intervention eg choosing suitable resourcesexercises to facilitate discussion around past treatment experiences will involve round table collaborative discussions with study personnel including the peer support worker and two members of the EPINS First Voice Advisory Group Discussions will first be centered around highlighting specific components of the initial Just Do You intervention and discussing intervention acceptability and feasibility of delivery As concerns may arise patient partners and study personnel will work collaboratively to modify intervention components to support intervention acceptability while ensuring modifications are consistent with theoretical and empirical underpinnings of the intervention During initial adaptation stages emphasis will be placed on actively engaging members of the EPINS First Voice Advisory Group who have had negative experiences with healthcare prior to engaging in EIS to ensure participants concerns are considered when adapting the Just Do You intervention It is anticipated that initial intervention adaptation will require a 9-12-hour commitment of each representative over 3 3- 4-hour initial meetings
Following adaptation of the intervention eligible clinicians and the peer support worker will be trained on delivering the intervention by a clinical psychology PhD student and a licensed clinical psychologist both of whom have experience working with this population and will be involved in initial adaptation of the Just Do You intervention Training will involve a full-day workshop lead by investigators which will include presentation of the intervention treatment targets underlying theory and role-play in delivering the intervention with clinicians and PSW Following training the investigators will begin delivery of the modified version of the Just Do You intervention to patients at the NSEPP
During implementation and delivery phase of the project study personnel will continue to meet with patient representatives once every two months at project steering committee meetings In these meetings patient representatives will be informed of any study updates and will collaborate with study investigators in finding solutions to encountered challenges including difficulties with intervention delivery or study recruitment Additionally when applicable in steering committee meetings patient partners and co-investigators will collaborate on reviewing and preparing relevant study material including ethics amendments consent forms and materials summarizing study findings to be shared with a broader audience As this project is anticipated to take 2-years to complete patient representatives will be required to attend 12 1-hour meetings with investigators in addition to the initial intervention adaptation meetings
Throughout patient engagement activities in this project The Public and Patient Engagement Evaluation Tool PPEET will be administered regularly once after each meeting to allow patient partners to provide regular feedback to research staff The PPEET is an evidence-based brief survey measure designed to gain patient partners assessments of engagement activities throughout the project Results from this measure will allow investigators to assess degree to which patient partners believe meaningful engagement in project processes has been achieved and results will be used on an ongoing basis to improve engagement processes during the study
Objectives 2 and 3 Delivering and evaluating the engagement intervention
Following adaptation of Just Do You delivery and evaluation of the intervention will begin A repeated measures quasi-experimental design will be used to evaluate the engagement interventions effectiveness This design is most suitable as randomization of participants to treatment or control may be unethical given existing evidence supporting the interventions effectiveness Consequently the investigators aim to approach all eligible patients within the first 3-12 months of treatment who have previously consented to being contacted for research purposes roughly 80 of overall patient population Eligible patients will be informed of the study protocolrationale as well as potential risks and benefits of participation in the intervention Following this eligible participants will choose between i full participation in the treatment group which involves engaging in the 2-part treatment intervention and completing study outcome assessments ii participation in the control group which involves completing outcome assessments during regular clinical visits without engaging in the intervention and iii refraining from participating in the study Following this those expressing interest in participating in either the treatment or control conditions will engage in a more in-depth consent discussion where additional specifics of participation will be outlined including risksbenefits confidentiality and the study protocol Individuals providing informed consent to participate in the study will then complete a baseline assessment This assessment includes completion of a demographic form which will include questions about participants age ethnicity migrant status gender identity and sexual orientation as well as questions about participants past experiences with mental healthcare and referral source In addition participants postal code will be collected and used to extrapolate an estimate of participants socioeconomic status SES using The Canadian Index of Multiple Deprivation CIMD This index developed by Statistics Canada uses postal code data to estimate individuals SES using participants geographical location on four dimensions Residential instability Economic dependency Ethno-cultural composition and Situational vulnerability These dimensions based on available evidence and up-to date census data and are widely used in Canadian health research as proxy multi-dimensional estimates of SES Collection of demographic data will allow investigators to better describe the participant sample and potentially allow for exploration of potential differential outcomes in minority communities
Participants will then complete a baseline clinical assessment which includes measures of engagement in treatment Yatchmenoff Client Engagement Scale self-reported recovery Recovery Assessment Scale psychotic symptom severity PANSS-6 global impression of illness severity Clinical CGI-I and -S Social and Occupational Functioning SOFAS illness insight SUMD current substance use WHO-ASSIST FC experiences of adverse and traumatic life events TALE and selfinternalized stigma ISMI These measures have all been validated and previously used in early psychosis populations The engagement and recovery measures were previously employed by investigators in the initial Just Do You trial and have been chosen to ensure comparability between studies
Intervention Procedure and Follow-up
Following baseline assessment participants receiving the intervention will engage in two intervention modules between 90-120 minutes each led by a clinician and PSW This intervention is based on the young adult framework for mental health and is informed by theories of health behaviour change and formal decision theory Targets of these sessions are common cognitive and affective barriers to engagement in mental health services for young adults especially those with past negative experiences with healthcare eg behavioural beliefs image impressions emotional reactions personal efficacy norms Following outlined practices and to reduce burden of participation participants will engage in the first module immediately following baseline assessment Module 1 will focus on discussions of the recovery process and principles of recovery while exploring stigma and participants perceptions and attitudes towards clinical service Module 2 which will be delivered 4-weeks following the first session will focus on processing prior difficult experiences with healthcare and psychosis and resulting perceptions towards treatment that commonly act as barriers to engagement Emphasis will be placed on instilling participants hope in recovery and building trust in current EIS
As the NSEPP largely provides care in person and study sessions are designed to coincide with participants regular treatment sessions at NSEPP Participants will be encouraged to complete the intervention modules in person However in order to increase accessibility to the intervention for participants who may have increased difficulty travelling to NSEPP participants will be given the option to attend sessions virtually through Zoom for Healthcare This interface has been carefully vetted by NS health for use with patients and is deemed to be the most secure virtual method to ensure patientparticipant privacy and security In addition to a baseline assessment treatment and control groups will complete follow up measures of participants self reported recovery and engagement outcomes 2 and 4-weeks following initial study enrollment Finally participants in the treatment group will complete assessment measures 3-months post-delivery of second session and control participants will complete measures 4-months following enrollment At final assessment participants PANSS-6 CGI-I SOFAS SUMD WHO-ASSIST and ISMI-9 scores will be measured in addition to participants recovery RAS and engagement scores Yatchmenoff client engagement scale Based on preference participants will be provided the option to complete self report measures at follow-up times either in person at the NSEPP or virtually Those electing to complete follow-up measures through REDCap will be invited by email to complete the web-based self-report measures De-identified data will be automatically entered into the secure web-based REDCap database capture platform with only participant ID approved by NS Health and managed in accordance with provincial privacy standards For participants electing to complete measures virtually clinician rated assessments will be completed in person at the NSEPP or completed virtually via Zoom for healthcare for NSHealth Completion of the above protocol will translate to a total length of follow up of 4 months for all participants
Objectives 4 and 5 Monitoring administrative health outcomes
In addition to evaluating effectiveness of the intervention by administering the above outcomes administrative health data will be used to explore intervention impact on participants high level clinical outcomes Firstly to obtain an additional objective indicator of participants treatment engagement the investigators will measure participants rate of missed appointments 3-months prior and 6-months following intervention In addition the investigators will measure rate of hospitalization and ER visits over the same time cumulative of visitsperson-year As the investigators have prior ethics approval to monitor high level demographic and outcome data for all NSEPP patients including those accepted to treatment who never engaged in EIS the investigators will use all past and present patients who did not receive the intervention as a comparison group and measure participants administrative health outcomes over the same timeline Finally outcomes for participants referred to NSEPP from urgent services will be compared to those of participants referred from other services to assess differential effectiveness of the intervention in previously identified high-risk groups
Data analysis plan
The goal of this project is to adapt the Just Do You intervention for use at NSEPP and deliver and evaluate the effectiveness of this intervention In accordance with the stated objectives and consistent with the initial Just Do You trial the investigators will measure changes in participants engagement recovery insight stigma and symptoms over follow-up and compare changes on these outcomes between control and active participants To address this first hypothesis - that participants who engaged in the intervention will show greater improvements in engagement self-reported recovery and insight compared to those in the control condition the investigators will use linear mixed regression models which are most suitable for repeated measures designs Potential differences in overall illness severity CGI-S PANSS-6 SOFAS WHO-ASSIST between control and treatment groups at baseline will be assessed using independent t-tests If significant differences on these measures are observed between groups baseline scores on these outcomes will be included as predictors in analyses in addition to treatment group The investigators aim to recruit 40 participants 20 controls and 20 intervention participants into the study This sample size was calculated to ensure 80 power of detecting the minimum effect size previously reported in the trial of the Just Do You intervention Cohens D ranged from 050 to 115 This sample is feasible given the clinics large patient pool 250 active patients 50 -70 new admissionsyear and the nature of research at NSEPP being embedded into clinical practice To measure impact of the intervention on participants self reported engagement recovery and insight the investigators will use linear mixed regression models which are suitable for repeated measures designs
To address the second and third hypotheses in fulfillment of study objectives 4 and 5 - that those receiving the study intervention will show a trend of fewer overall emergency department visits and hospitalizations for mental health reasons as well as fewer missed treatment appointments compared to those who received treatment as usual Poisson regression models will be used To assess for trends in rate of missed appointments hospitalization and ER visits and to compare potential differential outcomes for those referred to EIS via urgent or non-urgent sources both treatment group and referral source ie urgent vs non-urgent referral will be included as predictors in analyses using time of follow up as an offset variable in analysis If after reviewing the distribution of hospitalizations Poisson regression does not fit the data well ie data are over dispersed or are characterized by considerable proportion of sample not having urgent care visits modified Poisson regression can be used If the sample variance is significantly greater than the mean number of outcomes negative binomial regression will be used to account for this extra variance If data are skewed towards zero hospitalizations A zero inflated Poisson model will be used
Due to the small sample size 20 active participants and 20 controls with potential to include roughly 500 additional retrospective controls the investigators may not be adequately powered to detect small differences in administrative health outcomes between participant groups or include additional important demographic and clinical variables in analyses Nonetheless as this is a pilot project the investigators will assess and to report observed trends in health outcomes which are anticipated to act as preliminary proof of concept findings supporting potential subsequent follow-up studies It is the investigators aim that these initial study findings will facilitate potential follow-up studies evaluating this intervention that are adequately powered to detect differences in administrative health outcomes while control for additional potential confounders
To address the fourth hypothesis - That participants with past urgent service referral will benefit more from the intervention than those referred from other sources eg GP familyself Community mental health Subgroup comparisons will be conducted The overall effect size attributable to the intervention measured with Cohens D will be compared between participants with urgent vs non urgent referral to EIS
Confidentiality
The principal investigator will keep a file that links participant ID numbers to names that will be password-protected and stored on a computer that is housed at the Abbie J Lane building The only location where identifying information will be kept will be on the secure computer at NSEPP this information will be kept in a password-protected file and will be accessible only to the principal investigator and supervising investigators if necessary Research assistants and the peer support worker will have access to the de-identified file that contains ID numbers and the remainder of participant information eg outcomes In addition to being in a locked room in the NSEPP The computer on which files will be stored is also encrypted to prevent a breach of confidentiality should the computer be lost or stolen Potential participants contact information and information regarding date of acceptance to the NSEPP will be taken from the NSEPP clinic database of those participants who gave prior consent to the clinic to release this information for research purposes limiting the need to gain access to the potential participants health record Completed measures either paper and pencil or virtually through REDCap will be stored only with the date and unique participant ID number names or other identifying information will not be used Paper questionnaires will be kept separately each in a separate locked filing cabinet in a locked room with limited access Participant ID number and identifying information will be linked only through the password-protected file located on the principal investigators computer housed at the NSEPP Consent forms will be stored under lock and key in the principal investigators office at Abbie J Lane as will study data stored in a separate locked filing cabinet Seven years following the publication of the study results all data will be destroyedpermanently erased as required by the Nova Scotia Health Authority The records on the principal investigators computer will be permanently erased by the principal investigator with the assistance of IT and the physical records at the Abbie J Lane hospital will also be destroyed by the PI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None