Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487195
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-25
Brief Title:
Effects of a Peer-facilitated Recovery-focused Self-illness Management Program for First-episode Psychosis
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Effectiveness of a Peer-facilitated Recovery-focused Self-illness Management Program Peer-RESIM for First-episode Psychosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
Peer-RESIM
Brief Summary:
Psychosis is a major disabling and disruptive mental illness characterized by a wide variety of disturbances in cognition and emotions resulting in poor psychosocial functioning and frequent relapses Despite convincing evidence of short-term symptom control and functional recovery there has been a limited amount of data generated over the past two decades on the long-term outcomes of early interventions for psychotic patients especially first-episode psychosis FEP We propose a controlled trial with an adequate study power to examine the longer-term effects 18 months of a Peer-facilitated Recovery-focused Self-Illness-Management program Peer-RESIM for adults with FEP Specifically the proposed study will assess the effects of better-prepared PSWs and a culturally adapted intervention protocol designed by our multidisciplinary research team on improving patients self-care and recovery
Detailed Description:
People with first-episode psychosis FEP are often anxiousstressed and unprepared to manage the illness and associated disturbances of daily living and functioning Due to this unpreparedness for illness management and diverse adverse health effects in FEP different approaches to psychosocial interventions provide significant benefits in improving patients symptom management and preventing relapses However similar to early interventions inconsistentinconclusive results have been reported for most psychosocial health outcomes particularly over a long-term follow-up
There is increasing evidence showing that recovery-focused care is an effective approach to community-based psychiatric rehabilitation and mental health practice Using this approach empowered self-help and hope cultivation can help patients develop a sense of purpose and meaning in life and optimism for the future Peer support can be provided by ex-co-patients with similar illness experience who have been trained to provide voluntaryin-job mental health services Consequently they are well-placed to model and encourage active and autonomous recovery in their peers fellow-patients This innovative method of supporting recovery-focused mental healthcare is increasingly popular among those developing mental healthcare services and policies9 However there few high-quality trials have assessed this strategy and there is little evidence of its positive effects on functional and clinical recovery symptoms and hospitalizations and service satisfaction especially in Asian countries Structured self-help andor peer-supported training and practices may have the advantage of empowering and facilitating FEP patients to meet their co-patients real-life personal and illness care goals they also minimize professional input which may enhance the feasibility accessibility andor user-friendliness of an intervention and keep its cost of delivery low
Milton and our 1st-Co-I conducted a multi-center randomized controlled trial of peer-facilitated recovery from severe mental illness intervention in England using the Crisis- Resolution-Team Optimisation and RElapse PreventionCORE program In their trial significantly fewer participants in the treatment group n120 were admitted to inpatient care 29vs38 time-to-readmission was longer 112vs86 days and service satisfaction was higher 78vs41 than the usual care only group over a 1-year follow-up period A similar service is required in Hong Kong and this peer-facilitated self-management modelapproach can be adoptedtested
Mental healthcare should maximize the self-management of individual first-episode psychosis patients mental wellbeing peer support and experience-sharing for patients to improve their illness self-care and recovery Based on the findings of Miltons and our Co-Is randomized trial of CORE program a similar peer-facilitated recovery-based self-illness-management program can be adoptedtested in Hong Kong with cultural adaptations to match local service development strategiesneeds
This proposed randomized controlled trial tests two main hypotheses that
1 the Peer-facilitated Recovery-focused Self-Illness-Management program Peer-RESIM will yield significantly greater improvements than psychoeducation andor routine-care only at 1-week 9-month andor 18-month follow-ups in patients recovery and functioning primary outcomes
2 It also tests the hypothesis that the Peer-RESIM will yield significantly greater improvements than the other two groups at 1-week 9-month andor 18-month follow-ups in psychotic symptoms problem-solving re-hospitalization rates andor service satisfaction secondary outcomes
The trial examines whether the Peer-RESIM participants will indicate clinically significant changesbenefits in two primary outcomes at 1-week 9-month andor 18-month follow-ups
In addition focus-group interviews will be conducted to explore the perceived benefits service satisfaction and strengthslimitations of the Peer-RESIM from peer-facilitators and participants perspectives
Methods A assessor-blinded three-arm multi-centre RCT was conducted A list of 198 Chinese adult patients with FEP randomly selected from four Community Centers for Mental Wellness in Hong Kong in 2023 ie 16-17 subjectsgroup from each center a total of 66 participants per group and randomly assigned into one of the three study groups Peer-RESIM psycho-education or usual care only group by matching with computerized random numbers
After four-month interventions the patient outcomes will be measured at immediately 9 months and 18 months post-intervention and analysed on intention-to-treat basis Clinical significant changes in the primary outcomes will be assessed within and between groups according to Jacobson and Trauxs criteria to examine the clinical benefits to patients Focus-group interviews will also be conducted to explore the perceived benefits service satisfaction and strengthslimitations of the Peer-RESIM from peer-facilitators and participants perspectives
Study outcomes and variables
Socio-demographic and clinical data eg gender age clinical diagnosis illness duration and medications will be collected at baseline and changes in medications will be recorded during the study
Primary outcomes include the Questionnaire about the Process of Recovery QPR and the 43-item Specific Level of Functioning Scale
Secondary outcomes include the 30-item Positive and Negative Syndrome Scale PANSS the Revised Social-Problem-Solving Inventory C-SPSI-RS Frequency and length of time to rehospitalizations and the 8-item Client Satisfaction Questionnaire CSQ-8 Note illnesstreatment insight and drug attitude as appropriate
There is increasing evidence showing that recovery-focused care is an effective approach to community-based psychiatric rehabilitation and mental health practice Using this approach empowered self-help and hope cultivation can help patients develop a sense of purpose and meaning in life and optimism for the future Peer support can be provided by ex-co-patients with similar illness experience who have been trained to provide voluntaryin-job mental health services Consequently they are well-placed to model and encourage active and autonomous recovery in their peers fellow-patients This innovative method of supporting recovery-focused mental healthcare is increasingly popular among those developing mental healthcare services and policies9 However there few high-quality trials have assessed this strategy and there is little evidence of its positive effects on functional and clinical recovery symptoms and hospitalizations and service satisfaction especially in Asian countries Structured self-help andor peer-supported training and practices may have the advantage of empowering and facilitating FEP patients to meet their co-patients real-life personal and illness care goals they also minimize professional input which may enhance the feasibility accessibility andor user-friendliness of an intervention and keep its cost of delivery low
Milton and our 1st-Co-I conducted a multi-center randomized controlled trial of peer-facilitated recovery from severe mental illness intervention in England using the Crisis- Resolution-Team Optimisation and RElapse PreventionCORE program In their trial significantly fewer participants in the treatment group n120 were admitted to inpatient care 29vs38 time-to-readmission was longer 112vs86 days and service satisfaction was higher 78vs41 than the usual care only group over a 1-year follow-up period A similar service is required in Hong Kong and this peer-facilitated self-management modelapproach can be adoptedtested
Mental healthcare should maximize the self-management of individual first-episode psychosis patients mental wellbeing peer support and experience-sharing for patients to improve their illness self-care and recovery Based on the findings of Miltons and our Co-Is randomized trial of CORE program a similar peer-facilitated recovery-based self-illness-management program can be adoptedtested in Hong Kong with cultural adaptations to match local service development strategiesneeds
This proposed randomized controlled trial tests two main hypotheses that
1 the Peer-facilitated Recovery-focused Self-Illness-Management program Peer-RESIM will yield significantly greater improvements than psychoeducation andor routine-care only at 1-week 9-month andor 18-month follow-ups in patients recovery and functioning primary outcomes
2 It also tests the hypothesis that the Peer-RESIM will yield significantly greater improvements than the other two groups at 1-week 9-month andor 18-month follow-ups in psychotic symptoms problem-solving re-hospitalization rates andor service satisfaction secondary outcomes
The trial examines whether the Peer-RESIM participants will indicate clinically significant changesbenefits in two primary outcomes at 1-week 9-month andor 18-month follow-ups
In addition focus-group interviews will be conducted to explore the perceived benefits service satisfaction and strengthslimitations of the Peer-RESIM from peer-facilitators and participants perspectives
Methods A assessor-blinded three-arm multi-centre RCT was conducted A list of 198 Chinese adult patients with FEP randomly selected from four Community Centers for Mental Wellness in Hong Kong in 2023 ie 16-17 subjectsgroup from each center a total of 66 participants per group and randomly assigned into one of the three study groups Peer-RESIM psycho-education or usual care only group by matching with computerized random numbers
After four-month interventions the patient outcomes will be measured at immediately 9 months and 18 months post-intervention and analysed on intention-to-treat basis Clinical significant changes in the primary outcomes will be assessed within and between groups according to Jacobson and Trauxs criteria to examine the clinical benefits to patients Focus-group interviews will also be conducted to explore the perceived benefits service satisfaction and strengthslimitations of the Peer-RESIM from peer-facilitators and participants perspectives
Study outcomes and variables
Socio-demographic and clinical data eg gender age clinical diagnosis illness duration and medications will be collected at baseline and changes in medications will be recorded during the study
Primary outcomes include the Questionnaire about the Process of Recovery QPR and the 43-item Specific Level of Functioning Scale
Secondary outcomes include the 30-item Positive and Negative Syndrome Scale PANSS the Revised Social-Problem-Solving Inventory C-SPSI-RS Frequency and length of time to rehospitalizations and the 8-item Client Satisfaction Questionnaire CSQ-8 Note illnesstreatment insight and drug attitude as appropriate
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