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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Mental Health Center of Denver
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Greater Bridgeport Mental Health Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston University, Center for Psychiatric Rehabilitation
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. are 18 or older.
  2. 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).
  3. are interested in enhancing their community participation.
  4. are not currently receiving individual peer support services.
  5. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University Charles River Campus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mental Health Center of Denver
Connecticut State, Department of Mental Health and Addiction Services
Riverside Community Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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