- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03266614
"Recovery 4 US" - A Photovoice-based Social Media Program (R4US)
"Recovery 4 US" - A Photovoice-based Social Media Program to Enhance the Recovery and Community Participation of Individuals With Psychiatric Disabilities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized trial evaluating "Recovery 4 US", a social media program aimed at the enhancement of community participation and overall recovery of individuals with psychiatric disabilities.This innovative e-mental health program integrates Internet and mobile technologies and is designed to be a self-sustaining recovery-oriented virtual community for individuals living with a disabling mental illness based on the principles of Photovoice.
The "Recovery 4 US" program which includes a mobile phone application and a password protected website, has three main components: 1) receipt of daily hope-inspiring message, paired with a corresponding visual image; 2) creation and viewing of recovery-oriented Photovoice works; and 3) opportunity to attend community events initiated by members of the "Recovery 4 US" community.
The benefits of the "Recovery 4 US" program will be evaluated through a randomized trial with n=60 participants. The study will take place at the Boston University Center for Psychiatric Rehabilitation. Participants will be randomized to the experimental group (provided with a smartphone and access to "Recovery 4 US" application and website) or the control group (provided with a smartphone but without access to the "Recovery 4 US" app or website). We anticipate participation in the program will be associated with reduced loneliness, increased hopefulness, community participation, and overall recovery.
The recruitment goal for this study was amended to n=70.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Boston University Center for Psychiatric Rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- are 18 or older
- have been recipients of services at the BU CPR Recovery Center 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) as indicated in their records
- are interested in participating in a social media program
- are fluent in English
- have a basic ability to use a mobile phone
Exclusion Criteria:
- Inability to give full and knowing consent
Study Plan
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: Recovery 4 US
This group receives a smartphone with the Recovery 4 US application and access to the application website.
|
R4US is a social media program aimed at the enhancement of community participation and overall recovery of individuals with psychiatric disabilities.
Other Names:
|
|
No Intervention: Services as usual
This group receives a smartphone but no access to the Recovery 4 US application.
|
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
|
A 20-item 4-point Likert-type scale, widely used measure of loneliness and social isolation with Cronbach's alpha coefficients ranging from .89 to .94
|
Change from Baseline to 3 months to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Herth Hope Index
Time Frame: Change from Baseline to 3 months to 6 months
|
12 item 4-point Likert type scale measuring the level of generalized hopefulness of the individual; the reported Cronbach's alpha coefficient of internal consistency of the scale is .97
|
Change from Baseline to 3 months to 6 months
|
|
Perceived Stress Scale
Time Frame: Change from Baseline to 3 months to 6 months
|
10-item 5-point Likert-type scale self-report measure of the level of stress experienced at a given point of time.
It was designed to capture how unpredictable, uncontrollable and overloaded respondents find their lives based on their capacity to cope with stress.
Reported internal consistency coefficients for the scale ranged between 0.90 and 0.92
|
Change from Baseline to 3 months to 6 months
|
|
Multi-Dimensional Assessment of Community Participation
Time Frame: Change from Baseline to 3 months to 6 months
|
Consists of objective and subjective measures of community belonging, inclusion and participation
|
Change from Baseline to 3 months to 6 months
|
|
Recovery Assessment Scale
Time Frame: Change from Baseline to 3 months to 6 months
|
24-item 5-point Likert rating scale assessing the level of overall recovery among people with psychiatric disabilities.
|
Change from Baseline to 3 months to 6 months
|
|
BASIS-R
Time Frame: Change from Baseline to 3 months to 6 months
|
measures: mood disturbances, anxiety, interpersonal and role functioning, daily living skills, psychotic symptoms, impulsivity and substance use on a scale from no difficulty to extreme difficulty.
|
Change from Baseline to 3 months to 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zlatka Russinova, PhD, Boston University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4458
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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