Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551974
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
INTERconNEcT-Eds a Guided Self-help Mobile App to Improve Outcome in Eating Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of a Guided Self-help Mobile App to Improve Treatment Outcome for Individuals Suffering From Eating Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Eating disorders EDs are psychiatric illnesses characterised by pathological eating behaviours ranging from protracted undereating to recurrent loss of control over eating Based on the transdiagnostic approach EDs are triggered and maintained by interpersonal distress and difficulties to manage negative emotions Thus interpersonal skills have been implicated as important targets for change in the treatment In this project we will adopt digital technologies to improve treatment adherence and outcome of individuals with EDs by testing the effectiveness of an online self-help program delivered through a mobile app Specifically this project aims to establish if an online personalized self-help approach is feasible and effective in ameliorating eating disorder symptoms and distress We planned to conduct two randomised controlled trials to test the effectiveness of online guided self-help GSH in two different settings 1 the community and 2 the outpatient setting This is to establish at which stage of treatment this approach is most helpful Across studies we will recruit 242 individuals aged 18 years with ED symptoms andor a proper diagnosis of EDs DSM-5 During eight weeks period GSH will be available to participants both on a website and a new-developed smartphone app and consists of written materials and brief video-clips a weekly chat based forum group and an online interpersonal group session Guidance in forum groups will be facilitated by non-specialist help-care providers ie peer mentors whereas experienced mental health providers will lead the online group sessions Participants interpersonal distress will be assessed at intake to personalize guidance in the group by addressing dysfunctional interpersonal characteristics which can be associated with ED symptoms Participants will also complete a weekly working alliance measure to examine whether the quality of relationship with mentor predicts clients level of clinical change
Regarding the outpatient setting the first aim is to assess if GSH intervention is effective to improve the following primary outcome for patients with ED diagnosis 1 overall psychological distress In the community setting the study aims to examine if GSH is effective to improve the following primary outcomes for individuals with sub-threshold EDs 1 overall psychological distress 2 first contact with clinical services to manage their dysfunctional eating behaviors
Regarding the outpatient setting the first aim is to assess if GSH intervention is effective to improve the following primary outcome for patients with ED diagnosis 1 overall psychological distress In the community setting the study aims to examine if GSH is effective to improve the following primary outcomes for individuals with sub-threshold EDs 1 overall psychological distress 2 first contact with clinical services to manage their dysfunctional eating behaviors
Detailed Description:
Despite the disabling nature of eating disorders many individuals with EDs do not receive appropriate mental health care Recently the use of eHealth technology has been proposed as a potentially effective alternative to traditional inperson treatment delivery for those with EDs Specifically self-help programs include the use of materials such as books workbooks and videoclips to empower patients through information and skills to cope with the illness Guided self-help adds the element of guidance to the use of these materials
The project aims to exploit the use of highly scalable and inclusive digital technologies ie mobile app and online GSH to improve the transdiagnostic understanding of EDs and their psychological treatment Online GSH will be developed based on pre-existing UK-based model of intervention RecoveryMANTRA and ECHOMANTRA and will be adapted to Italian young adults through the introduction of a smartphone app aimed to monitor and support individuals to treatment This project aims to establish at what stage of illness the evidence-based interventions used are most valued and beneficial to individuals Therefore online GSH will be tested in two different settings and clinical context 1 the outpatient setting for those reporting a diagnosis of ED and 2 the community setting for those reporting dysfunctional eating behaviors given that a majority of individuals reporting eating symptoms do not meet the full syndrome criteria GSH translated for delivery through smartphone app may be one solution towards reducing treatment gap for subthreshold-level EDs who do not still receive a proper support fostering awareness and motivation to start treatment as well as an augmenting strategy to improve clinical outcomes for patients undergoing routine treatment delivered by clinical services
Primary aims Regarding the outpatient setting the first aim is to assess if GSH intervention is effective to improve the following primary outcome for patients with ED diagnosis 1 overall psychological distress Secondary outcomes are 1 eating disorder psychopathology 2 interpersonal distress 3 quality of life 4 motivation for treatment 5 emotion dysregulation 6 Body Mass Index 7 satisfaction with treatment at the end of the 8-week intervention and 3-month follow-up compared to the control condition
In the community setting the study aims to examine if GSH is effective to improve the following primary outcome for individuals with sub-threshold EDs 1 overall psychological distress Secondary outcomes are 1 eating disorder psychopathology 2 interpersonal distress 3 quality of life 4 motivation for treatment 5 emotion dysregulation 6 Body Mass Index 7 satisfaction with treatment 8 first contact with clinical services to manage their dysfunctional eating behaviors at the end of the 8-week GSH and at 3-month follow-up compared to the control condition Secondary aims A secondary aim is to determine the extent to which the working alliance with clinicians delivering weekly online group guidance is associated with clients clinical changes on a session-by-session basis during the intervention Given the difficult nature of building a strong therapeutic alliance with ED patients Warren Crowley Olivardia Schoen 2008 an increased willingness to trust in clinician during the online GSH may be a basis for increased treatment involvement and symptomatic improvement
Study 1 The first study is a multicentric RCT where participants with a proper diagnosis of eating disorders will be recruited at the Eating Disorders Unit of the University Hospital of Catanzaro and Padova The aim of this RCT is to answer to the question Does online guided self-help through mobile app for eating disorders provided in addition to TAU improve overall psychological distress eating disorder psychopathology BMI interpersonal distress quality of life motivation for treatment emotion dysregulation satisfaction with treatment compared to treatment as usual alone outpatient treatment among young people with a diagnosis of eating disorders
Participants will be randomized to one of two groups 1 online guided self-help treatment as usual EDs standard treatment by participating centres or 2 treatment as usual only After completing informed consent and baseline questionnaires participants will be randomised to the intervention or control group using a web-based randomisation tool Randomization will take place in blocks in size of 16 participants with a 11 allocation ratio to ensure a random allocation of 8 participants in each group per time The participants allocated in the intervention arm will get access to self-help materials workbook and videoclips forum groups interactional materials and online interpersonal group sessions for 8 weeks
Study 2 In this RCT participants will be recruited from the community through advertisements posted in the psychoeducation Instagram profile Dicci Come Aiutarti Albano et al 2023 The aim of this RCT is to answer to the question Does online guided self-help through mobile app for eating disorders improve overall psychological distress as well as eating disorder psychopathology BMI interpersonal distress quality of life motivation for treatment emotion dysregulation satisfaction with treatment and service use compared to a no treatment condition A secondary aim of this trial is to evaluate if during the ongoing trial or at the end of the intervention 8 weeks participants start a clinical intervention in a specialized service to manage their eating difficulties
Participants will be randomized to one of two groups 1 online guided self-help without online interpersonal sessions or 2 TAU only GP consultation After completing informed consent and baseline questionnaires participants will be randomised to the intervention or control group using a web-based randomisation tool with a 11 allocation ratio
Guided self-help intervention The proposed 8-week online GSH will be adapted from two online interventions developed and tested with people with eating disorders by the Eating Disorders Research Unit team at Kings College London with a cooperation of the University of Palermo research team Cardi et al 2020 The GSH will include self-help materials ie a written workbook and a library of 74 brief video-clips with the goal of providing psychoeducation about eating disorders and interpersonal difficulties and describing and modelling the use of helpful strategies to reverse abnormal eating behaviours Participants will use self-help materials through a mobile app and online platform which will be developed and implemented by the Tech Digit Easy srl a company leader in the design and development of E-health services and devices which has been cooperating with the Research Unit of the University of Palermo for 2 years Regarding anorexic symptoms and behaviours the self-help material will focus on the topics of the New Maudsley model Therefore participants will get the chance to work on six main areas related to EDs maintenance factors On the other hand further modules will cover the ED overeating behaviors through the Italian translation of the manual Getting Better Bite by Bite A Survival Kit for Sufferers of Bulimia Nervosa and Binge Eating Disorders Schmidt Treasure Alexander 2012 Finally a module on interpersonal difficulties related to EDs will be provided to all participants as a transdiagnostic maintenance illness factor to be addressed Rieger Van Buren Bishop Tanofsky-Kraff Welch Wilfley 2010 Wilfley et al 2002
A further service offered through the mobile app will be the chance to get access to a weekly online forum group interactional material aimed to foster the adherence to the self-help program and the use of online materials A focus on motivation to change instilling hope on the recovery will be promoted through motivational interviewing framework and the lived experience of influencers who recovered from an EDs collaborators of DCA This additional interactional material will be delivered weekly through a synchronous 1-hour mobile chat with a peer mentor a recovered influencer from an EDs and a low experienced professional graduated students in psychology Each session lasts 60 minutes and is themed following the structure of the patient video-clips materials
In this project interpersonal group sessions IPT involve 90-minute weekly online sessions Murphy et al 2012 Group sessions will be led by clinicians with a good expertise in the treatment of eating disorders The interpersonal group sessions could be attended by those participants enrolled in the study and recruited from clinical centres with a proper diagnosis of eating disorder The interpersonal group sessions will be delivered through a zoom link available in the online platform A group of 6-8 participants diagnosed with various eating disorders including AN BN and BED will be included with the aim of addressing the interpersonal difficulties related to nutrition and eating management
Statistical Analysis Power analysis An a-priori sample size was estimated using GPower based on previous research findings eg Cardi et al 2020 Traviss-Turner et al 2017 Considering a mixed design factorial ANOVA a statistical power of 1 - β 90 alpha level of 05 a small effect size Cohens f 10 in mean improvement for outcome variables and medium to high stability of the outcomes across time points r 60 the power analysis suggested a sample to include 86 subjects per group with a total of 172 participants in the study 1 An a-priori sample size was estimated using GPower based on previous research findings eg Linardon Shatte Rosato Fuller-Tyszkiewicz 2022 Considering a mixed design factorial ANOVA a statistical power of 1 - β 80 a two-tailed alpha level and a small effect size Cohens f 10 in mean improvement for outcome variables and medium to high stability of the outcomes across time points r 60 the power analysis suggested a sample to include 35 subjects per group with a total of 70 participants in the study 2
For first aim Univariate analyses of variance will be used to compare the intervention and control arms on the clinical outcomes All analyses will be based on the intention-to-treat approach Missing data will be imputed using multiple imputation based upon the Markov chain Monte Carlo method and maximum likelihood imputation based upon the Expectation-Maximization EM algorithm Results will be compared across the two methods Effect sizes will be calculated using Cohens d For the secondary aim The random intercepts cross-lagged panel model will assess the bidirectional association between working alliance and post-session weekly outcomes EDE-Q CORE-10 etc The random intercept in the model removes between-person variance ie Level 2 such that the lagged relationships in the cross-lagged model characterize within-person change over time Three fit indices will be used to evaluate the fit of the model the comparative fit index CFI root mean square error of approximation RMSEA and standardized root mean square residual SRMR Two models will be estimated one with the auto-correlation and the cross-lagged paths freely estimated and a second model with the auto-correlation and the cross-lagged paths constrained to be equal across time periods
The project aims to exploit the use of highly scalable and inclusive digital technologies ie mobile app and online GSH to improve the transdiagnostic understanding of EDs and their psychological treatment Online GSH will be developed based on pre-existing UK-based model of intervention RecoveryMANTRA and ECHOMANTRA and will be adapted to Italian young adults through the introduction of a smartphone app aimed to monitor and support individuals to treatment This project aims to establish at what stage of illness the evidence-based interventions used are most valued and beneficial to individuals Therefore online GSH will be tested in two different settings and clinical context 1 the outpatient setting for those reporting a diagnosis of ED and 2 the community setting for those reporting dysfunctional eating behaviors given that a majority of individuals reporting eating symptoms do not meet the full syndrome criteria GSH translated for delivery through smartphone app may be one solution towards reducing treatment gap for subthreshold-level EDs who do not still receive a proper support fostering awareness and motivation to start treatment as well as an augmenting strategy to improve clinical outcomes for patients undergoing routine treatment delivered by clinical services
Primary aims Regarding the outpatient setting the first aim is to assess if GSH intervention is effective to improve the following primary outcome for patients with ED diagnosis 1 overall psychological distress Secondary outcomes are 1 eating disorder psychopathology 2 interpersonal distress 3 quality of life 4 motivation for treatment 5 emotion dysregulation 6 Body Mass Index 7 satisfaction with treatment at the end of the 8-week intervention and 3-month follow-up compared to the control condition
In the community setting the study aims to examine if GSH is effective to improve the following primary outcome for individuals with sub-threshold EDs 1 overall psychological distress Secondary outcomes are 1 eating disorder psychopathology 2 interpersonal distress 3 quality of life 4 motivation for treatment 5 emotion dysregulation 6 Body Mass Index 7 satisfaction with treatment 8 first contact with clinical services to manage their dysfunctional eating behaviors at the end of the 8-week GSH and at 3-month follow-up compared to the control condition Secondary aims A secondary aim is to determine the extent to which the working alliance with clinicians delivering weekly online group guidance is associated with clients clinical changes on a session-by-session basis during the intervention Given the difficult nature of building a strong therapeutic alliance with ED patients Warren Crowley Olivardia Schoen 2008 an increased willingness to trust in clinician during the online GSH may be a basis for increased treatment involvement and symptomatic improvement
Study 1 The first study is a multicentric RCT where participants with a proper diagnosis of eating disorders will be recruited at the Eating Disorders Unit of the University Hospital of Catanzaro and Padova The aim of this RCT is to answer to the question Does online guided self-help through mobile app for eating disorders provided in addition to TAU improve overall psychological distress eating disorder psychopathology BMI interpersonal distress quality of life motivation for treatment emotion dysregulation satisfaction with treatment compared to treatment as usual alone outpatient treatment among young people with a diagnosis of eating disorders
Participants will be randomized to one of two groups 1 online guided self-help treatment as usual EDs standard treatment by participating centres or 2 treatment as usual only After completing informed consent and baseline questionnaires participants will be randomised to the intervention or control group using a web-based randomisation tool Randomization will take place in blocks in size of 16 participants with a 11 allocation ratio to ensure a random allocation of 8 participants in each group per time The participants allocated in the intervention arm will get access to self-help materials workbook and videoclips forum groups interactional materials and online interpersonal group sessions for 8 weeks
Study 2 In this RCT participants will be recruited from the community through advertisements posted in the psychoeducation Instagram profile Dicci Come Aiutarti Albano et al 2023 The aim of this RCT is to answer to the question Does online guided self-help through mobile app for eating disorders improve overall psychological distress as well as eating disorder psychopathology BMI interpersonal distress quality of life motivation for treatment emotion dysregulation satisfaction with treatment and service use compared to a no treatment condition A secondary aim of this trial is to evaluate if during the ongoing trial or at the end of the intervention 8 weeks participants start a clinical intervention in a specialized service to manage their eating difficulties
Participants will be randomized to one of two groups 1 online guided self-help without online interpersonal sessions or 2 TAU only GP consultation After completing informed consent and baseline questionnaires participants will be randomised to the intervention or control group using a web-based randomisation tool with a 11 allocation ratio
Guided self-help intervention The proposed 8-week online GSH will be adapted from two online interventions developed and tested with people with eating disorders by the Eating Disorders Research Unit team at Kings College London with a cooperation of the University of Palermo research team Cardi et al 2020 The GSH will include self-help materials ie a written workbook and a library of 74 brief video-clips with the goal of providing psychoeducation about eating disorders and interpersonal difficulties and describing and modelling the use of helpful strategies to reverse abnormal eating behaviours Participants will use self-help materials through a mobile app and online platform which will be developed and implemented by the Tech Digit Easy srl a company leader in the design and development of E-health services and devices which has been cooperating with the Research Unit of the University of Palermo for 2 years Regarding anorexic symptoms and behaviours the self-help material will focus on the topics of the New Maudsley model Therefore participants will get the chance to work on six main areas related to EDs maintenance factors On the other hand further modules will cover the ED overeating behaviors through the Italian translation of the manual Getting Better Bite by Bite A Survival Kit for Sufferers of Bulimia Nervosa and Binge Eating Disorders Schmidt Treasure Alexander 2012 Finally a module on interpersonal difficulties related to EDs will be provided to all participants as a transdiagnostic maintenance illness factor to be addressed Rieger Van Buren Bishop Tanofsky-Kraff Welch Wilfley 2010 Wilfley et al 2002
A further service offered through the mobile app will be the chance to get access to a weekly online forum group interactional material aimed to foster the adherence to the self-help program and the use of online materials A focus on motivation to change instilling hope on the recovery will be promoted through motivational interviewing framework and the lived experience of influencers who recovered from an EDs collaborators of DCA This additional interactional material will be delivered weekly through a synchronous 1-hour mobile chat with a peer mentor a recovered influencer from an EDs and a low experienced professional graduated students in psychology Each session lasts 60 minutes and is themed following the structure of the patient video-clips materials
In this project interpersonal group sessions IPT involve 90-minute weekly online sessions Murphy et al 2012 Group sessions will be led by clinicians with a good expertise in the treatment of eating disorders The interpersonal group sessions could be attended by those participants enrolled in the study and recruited from clinical centres with a proper diagnosis of eating disorder The interpersonal group sessions will be delivered through a zoom link available in the online platform A group of 6-8 participants diagnosed with various eating disorders including AN BN and BED will be included with the aim of addressing the interpersonal difficulties related to nutrition and eating management
Statistical Analysis Power analysis An a-priori sample size was estimated using GPower based on previous research findings eg Cardi et al 2020 Traviss-Turner et al 2017 Considering a mixed design factorial ANOVA a statistical power of 1 - β 90 alpha level of 05 a small effect size Cohens f 10 in mean improvement for outcome variables and medium to high stability of the outcomes across time points r 60 the power analysis suggested a sample to include 86 subjects per group with a total of 172 participants in the study 1 An a-priori sample size was estimated using GPower based on previous research findings eg Linardon Shatte Rosato Fuller-Tyszkiewicz 2022 Considering a mixed design factorial ANOVA a statistical power of 1 - β 80 a two-tailed alpha level and a small effect size Cohens f 10 in mean improvement for outcome variables and medium to high stability of the outcomes across time points r 60 the power analysis suggested a sample to include 35 subjects per group with a total of 70 participants in the study 2
For first aim Univariate analyses of variance will be used to compare the intervention and control arms on the clinical outcomes All analyses will be based on the intention-to-treat approach Missing data will be imputed using multiple imputation based upon the Markov chain Monte Carlo method and maximum likelihood imputation based upon the Expectation-Maximization EM algorithm Results will be compared across the two methods Effect sizes will be calculated using Cohens d For the secondary aim The random intercepts cross-lagged panel model will assess the bidirectional association between working alliance and post-session weekly outcomes EDE-Q CORE-10 etc The random intercept in the model removes between-person variance ie Level 2 such that the lagged relationships in the cross-lagged model characterize within-person change over time Three fit indices will be used to evaluate the fit of the model the comparative fit index CFI root mean square error of approximation RMSEA and standardized root mean square residual SRMR Two models will be estimated one with the auto-correlation and the cross-lagged paths freely estimated and a second model with the auto-correlation and the cross-lagged paths constrained to be equal across time periods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None