"Recovery 4 US" - A Photovoice-based Social Media Program (R4US)

November 28, 2018 updated by: Zlatka Russinova, Boston University Charles River Campus

"Recovery 4 US" - A Photovoice-based Social Media Program to Enhance the Recovery and Community Participation of Individuals With Psychiatric Disabilities

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.

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

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

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.
68

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston University Center for Psychiatric Rehabilitation

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:

  • 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

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: Recovery 4 US
This group receives a smartphone with the Recovery 4 US application and access to the application website.
Behavioral: Recovery 4 Us
R4US is a social media program aimed at the enhancement of community participation and overall recovery of individuals with psychiatric disabilities.
Other Names:
  • R4US
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

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
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

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
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

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

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: Zlatka Russinova, 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.
April 7, 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.
July 1, 2018

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.
July 1, 2018

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).
August 28, 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.
August 28, 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.
August 30, 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.
November 30, 2018

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.
November 28, 2018

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.
November 1, 2018

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.
  • 4458

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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