Ignite Creation Date:
2024-05-06 @ 7:15 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02508480
Status:
COMPLETED
Last Update Posted:
2020-04-10
First Post:
2015-07-23
Brief Title:
Testing Effectiveness of a Peer-Led Intervention to Enhance Community Integration
Sponsor:
Boston University Charles River Campus
Organization:
Boston University Charles River Campus
Study Overview
Official Title:
Testing Effectiveness of a Peer-Led Intervention to Enhance Community Integration
Status:
COMPLETED
Status Verified Date:
2020-03
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:
Photovoice
Brief Summary:
We are conducting a randomized clinical trial RCT comparing the 10-week peer-led Photovoice program to services as usual SAU at a large publicly funded community mental health agency in Massachusetts The control SAU condition will be enhanced with a 60-minute peer-led group educational session about understanding and coping with prejudice and discrimination The 10-session peer-led Photovoice program designed to empower individuals with serious mental illness SMI to confront public prejudice and discrimination and reduce personal stigma self-stigma and perceived stigma was developed and pilot tested at our Center with primary contributions from staff with a lived experience of mental illness Development of the Photovoice program was guided by an adaptation of the stress-coping model informed by recent research and conceptualizations of the effects of stigma on people with SMI The stress-coping model explicates the mechanisms by which public stigma about mental illness can lead to personal stigma which in turn has a negative impact on the persons mental health and psychosocial functioning This model also identifies critical factors that contribute to personal stigma or protect against it as well as more vs less adaptive coping responses that are the primary focus of the Photovoice program
Detailed Description:
We are conducting a RCT comparing the 10-week peer-led Photovoice program to services as usual SAU enhanced with a 60-minute peer-led group discussion session The RCT will be at a large publicly funded community mental health agency in Massachusetts A total of 192 participants or 96 participants per group will be recruited over a period of 36 months across the three clubhouses of the agency where the intervention will take place We plan to have randomization cohorts of 16 individuals per delivery of the Photovoice program at each of the three clubhouses Given the projected sample size of 192 participants we will have 12 randomization cohorts - 4 at each clubhouse implemented at 6-month intervals Participants will be randomized to either the Photovoice program plus usual services or the enhanced SAU Participants will be assessed by a blinded rater at baseline post-treatment 3-month and 6-month follow-ups on a range of primary and secondary outcomes related to personal stigma coping and functioning Primary analyses will test the hypotheses that the Photovoice program will lead to significantly greater reductions in self-stigma and perceived stigma greater improvements in proactive coping with psychiatric prejudice and discrimination and greater improvements in community functioning and integration than the enhanced SAU Secondary analyses will evaluate whether the Photovoice program leads to greater gains than SAU in psychological adjustment including wellbeing personal growth and recovery Individuals randomized to the enhanced SAU will be able to join the 10-week Photovoice program once they complete their 6-month follow up for the study
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