- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03291717
Bridging Community Gaps Photovoice (BCGP)
September 12, 2020 updated by: Erna Sally Rogers, Boston University Charles River Campus
Randomized Trial of a Peer-led Intervention to Promote Community Living and Participation - The Bridging Community Gaps Photovoice
The purpose of this study is to test a peer-led intervention intended to promote the community living and participation of individuals with psychiatric disabilities entitled "Bridging Community Gaps Photovoice" (BCGP).
The intervention targets increasing community involvement of individuals with psychiatric disabilities through reduction in self-stigma and perceived stigma, enhancing opportunities for community participation, and support to achieve community participation goals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The BCGP intervention is 6 months long and the investigators expect that participants will experience lower self and perceived stigma, increased community participation and sense of belonging, and improved psychosocial functioning and personal growth after the intervention.
The intervention is comprised of a 12-week class that meets once a week for two hours, followed by three booster sessions - one per month in the three months following the class, and up to 24 sessions of individual support as needed throughout the 6 months provided on a weekly basis either in person or by phone.
The purpose of the individual support is to reinforce the class activities and to ensure the participants meets their community participation goal.
The proposed study is a randomized trial which will be conducted at Boston University Center for Psychiatric Rehabilitation (BUCPR) in Massachusetts, the Mental Health Center of Denver (MHCD) in Colorado, and the Greater Bridgeport Mental Health Center (GBMHC) in Connecticut.
Study Type
Interventional
Enrollment (Actual)
197
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80204
- Mental Health Center of Denver
-
-
Connecticut
-
Bridgeport, Connecticut, United States, 06610
- Greater Bridgeport Mental Health Center
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Boston University, Center for Psychiatric Rehabilitation
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Wakefield, Massachusetts, United States, 01880
- Horizon House- Riverside Community Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- are 18 or older.
- are recipients of services at research sites due to having a DSM-V diagnosis of mental illness, including dual diagnosis (dual diagnosis refers to co-occurring mental illness and alcohol/ substance use disorder).
- are interested in enhancing their community participation.
- are not currently receiving individual peer support services.
- are able to read and write in English.
Exclusion Criteria:
1)Inability to give full and knowing consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bridging Community Gaps Photovoice (BCGP)
The BCGP program is a 6-month photovoice-based intervention to help individuals with psychiatric disabilities enhance their community participation.
|
Participants assigned to this group will be part of the 6-month long BCGP intervention, which involves a 12- week class that meets weekly, followed by three booster sessions - one per month in the three months following the class, and up to 24 sessions of individual support as needed throughout the 6 months provided on a weekly basis either in person or by phone.
The BCGP classes follow a manualized curriculum with sessions that combine didactic information, Photovoice exercises, and group discussions to empower participants in pursuing community participation goals, all refined with input from individuals with a lived experience.
|
|
No Intervention: Services as Usual
Individuals in this group continue with their regular mental health services with no additional intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
UCLA Loneliness Scale
Time Frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
is a 20-item 4-point Likert-type scale, widely used measure of loneliness and social isolation.
Cronbach's alpha coefficients ranging from .89 to .94.
|
Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
|
Multi-Dimensional Assessment of Community Participation
Time Frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
Consists of a set of objective and subjective measures of community belonging, inclusion and participation.
|
Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Internalized Stigma of Mental Illness Scale
Time Frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
29-item, 4-point scale from (strongly disagree to strongly agree) assesses behaviors, thoughts and feelings that are self-stigmatizing including alienation, stereotype endorsement, social withdrawal, stigma resistance.
|
Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
|
The Stigma Scale
Time Frame: Change from Baseline to 3 months, 3 months to 6 months, 6 months to 9 months, 9 months to 12 months
|
28 item, 5 point scale (strongly disagree to strongly agree) measuring experienced and anticipated stigma.
|
Change from Baseline to 3 months, 3 months to 6 months, 6 months to 9 months, 9 months to 12 months
|
|
Approaches to Coping with Anti-Stigma
Time Frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
27-item instrument with a 4 point scale (strongly disagree to strongly agree) measuring strategies to cope with stigma: secrecy, withdrawal, educating, challenging, and distancing.
|
Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
|
Personal Growth and Recovery Scale
Time Frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
25-item, 4 point scale (strongly disagree to strongly agree) of items measuring psychosocial functioning and recovery.
|
Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
|
Community Goal Achievement Scale
Time Frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
adapted from Goal Attainment Scale, provides a structured approach to determining goal achievement regardless of the type or uniqueness of goal .
|
Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
|
Behavior and Symptom Identification Scale (BASIS - R)
Time Frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
A 24-item scale that measures: mood disturbances, anxiety, interpersonal and role functioning, daily living skills, psychotic symptoms, impulsivity and substance use
|
Change from Baseline to 3 months to 6 months to 9 months to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Erna S Rogers, PhD, Boston University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2017
Primary Completion (Actual)
September 11, 2020
Study Completion (Actual)
September 11, 2020
Study Registration Dates
First Submitted
September 19, 2017
First Submitted That Met QC Criteria
September 21, 2017
First Posted (Actual)
September 25, 2017
Study Record Updates
Last Update Posted (Actual)
September 16, 2020
Last Update Submitted That Met QC Criteria
September 12, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4591
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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