Mental IllnessBCGPNCT03291717
Bridging Community Gaps Photovoice
A study testing Bridging Community Gaps Photovoice (BCGP) in people with Mental Illness and Social Isolation, run by Boston University Charles River Campus at 4 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness, Social Isolation
- What is being tested?
- Bridging Community Gaps Photovoice (BCGP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Sep 2017to 11 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1)Inability to give full and knowing consent.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boston University, Center for Psychiatric Rehabilitation
Boston, Massachusetts, 02215
Greater Bridgeport Mental Health Center
Bridgeport, Connecticut, 06610
Mental Health Center of Denver
Denver, Colorado, 80204
Horizon House- Riverside Community Care
Wakefield, Massachusetts, 01880
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Illness, Social Isolation
- Being tested
- Bridging Community Gaps Photovoice (BCGP)
- Keywords
- Mental Illness, Community Participation, Stigma, Photovoice
- Medical subject headings
- Mental Disorders, Social Isolation, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridging Community Gaps Photovoice (BCGP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Bridging Community Gaps Photovoice (BCGP) | Experimental | The BCGP program is a 6-month photovoice-based intervention to help individuals with psychiatric disabilities enhance their community participation. Receives: Behavioral: Bridging Community Gaps Photovoice (BCGP) |
| Services as Usual | No intervention | Individuals in this group continue with their regular mental health services with no additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Loneliness Scale
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.
Measured: Change from Baseline to 3 months to 6 months to 9 months to 12 months
Multi-Dimensional Assessment of Community Participation
Consists of a set of objective and subjective measures of community belonging, inclusion and participation.
Measured: Change from Baseline to 3 months to 6 months to 9 months to 12 months
Secondary outcomes (6)
Internalized Stigma of Mental Illness Scale
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.
Measured: Change from Baseline to 3 months to 6 months to 9 months to 12 months
The Stigma Scale
28 item, 5 point scale (strongly disagree to strongly agree) measuring experienced and anticipated stigma.
Measured: 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
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.
Measured: Change from Baseline to 3 months to 6 months to 9 months to 12 months
Personal Growth and Recovery Scale
25-item, 4 point scale (strongly disagree to strongly agree) of items measuring psychosocial functioning and recovery.
Measured: Change from Baseline to 3 months to 6 months to 9 months to 12 months
Community Goal Achievement Scale
adapted from Goal Attainment Scale, provides a structured approach to determining goal achievement regardless of the type or uniqueness of goal .
Measured: Change from Baseline to 3 months to 6 months to 9 months to 12 months
Behavior and Symptom Identification Scale (BASIS - R)
A 24-item scale that measures: mood disturbances, anxiety, interpersonal and role functioning, daily living skills, psychotic symptoms, impulsivity and substance use
Measured: Change from Baseline to 3 months to 6 months to 9 months to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start5 Sep 2017
- Primary completion11 Sep 2020
- Study completion11 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Mental Health Center of Denver, Connecticut State, Department of Mental Health and Addiction Services, Riverside Community Care
- Responsible party
- Principal investigator, Erna Sally Rogers, Boston University Charles River Campus
- Investigators
- Erna S Rogers, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291717
- Sponsor's protocol ID
- 4591
- Acronym
- BCGP
- Status last verified
- Sep 2020
- First submitted
- 19 Sep 2017
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Peer-led Intervention to Promote Community Living and Participation - The Bridging Community Gaps Photovoice
- ClinicalTrials.gov ID
- NCT03291717
- Acronym / sponsor ID
- BCGP / 4591
- Conditions
- Mental Illness, Social Isolation
- Keywords
- Mental Illness, Community Participation, Stigma, Photovoice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Mental Health Center of Denver, Connecticut State, Department of Mental Health and Addiction Services, Riverside Community Care
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bridging Community Gaps Photovoice (BCGP) | Experimental | Behavioral: 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. |
| Services as Usual | No intervention | –Individuals in this group continue with their regular mental health services with no additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1)Inability to give full and knowing consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bridging Community Gaps Photovoice (BCGP)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. | Behavioural | Bridging Community Gaps Photovoice (BCGP) |
Primary outcome
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.
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.
6 secondary outcomes
Internalized Stigma of Mental Illness Scale
Time frame: 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
Approaches to Coping with Anti-Stigma
Time frame: 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
Community Goal Achievement Scale
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erna S Rogers, PhD principal investigator
Boston University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bridging Community Gaps Photovoice (BCGP) in people with Mental Illness and Social Isolation, run by Boston University Charles River Campus at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA Loneliness Scale (time frame: Change from Baseline to 3 months to 6 months to 9 months to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.