Mental IllnessR4USNCT03266614
"Recovery 4 US" - A Photovoice-based Social Media Program
A study testing Recovery 4 Us in people with Mental Illness and Social Isolation, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness, Social Isolation, Loneliness
- What is being tested?
- Recovery 4 Us
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2017to 1 Jul 2018
- 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
- 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
Who cannot join
- Inability to give full and knowing consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Center for Psychiatric Rehabilitation
Boston, Massachusetts, 02215
About this study
Official title: "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.
Read the 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.
- Conditions
- Mental Illness, Social Isolation, Loneliness
- Being tested
- Recovery 4 Us
- Keywords
- Mental Illness, Loneliness, Hope, Community, Social Media
- Medical subject headings
- Mental Disorders, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery 4 UsBehavioural
Also called R4US
R4US is a social media program aimed at the enhancement of community participation and overall recovery of individuals with psychiatric disabilities.
| Study group | Role | What they receive |
|---|---|---|
| Recovery 4 US | Experimental | This group receives a smartphone with the Recovery 4 US application and access to the application website. Receives: Behavioral: Recovery 4 Us |
| Services as usual | No intervention | This group receives a smartphone but no access to the Recovery 4 US application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Loneliness Scale
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
Measured: Change from Baseline to 3 months to 6 months
Secondary outcomes (5)
Herth Hope Index
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
Measured: Change from Baseline to 3 months to 6 months
Perceived Stress Scale
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
Measured: Change from Baseline to 3 months to 6 months
Multi-Dimensional Assessment of Community Participation
Consists of objective and subjective measures of community belonging, inclusion and participation
Measured: Change from Baseline to 3 months to 6 months
Recovery Assessment Scale
24-item 5-point Likert rating scale assessing the level of overall recovery among people with psychiatric disabilities.
Measured: Change from Baseline to 3 months to 6 months
BASIS-R
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.
Measured: Change from Baseline to 3 months to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start7 Apr 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zlatka Russinova, Boston University Charles River Campus
- Investigators
- Zlatka Russinova, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266614
- Sponsor's protocol ID
- 4458
- Acronym
- R4US
- Status last verified
- Nov 2018
- First submitted
- 28 Aug 2017
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Recovery 4 US" - A Photovoice-based Social Media Program to Enhance the Recovery and Community Participation of Individuals With Psychiatric Disabilities
- ClinicalTrials.gov ID
- NCT03266614
- Acronym / sponsor ID
- R4US / 4458
- Conditions
- Mental Illness, Social Isolation, Loneliness
- Keywords
- Mental Illness, Loneliness, Hope, Community, Social Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 30 Aug 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery 4 US | Experimental | Behavioral: Recovery 4 UsThis group receives a smartphone with the Recovery 4 US application and access to the application website. |
| Services as usual | No intervention | –This group receives a smartphone but no access to the Recovery 4 US application. |
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
- 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
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Recovery 4 UsAlso: R4USR4US is a social media program aimed at the enhancement of community participation and overall recovery of individuals with psychiatric disabilities. | Behavioural | Recovery 4 US |
Primary outcome
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
5 secondary outcomes
Herth Hope Index
Time frame: Change from Baseline to 3 months to 6 months
Perceived Stress Scale
Time frame: 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
Recovery Assessment Scale
Time frame: Change from Baseline to 3 months to 6 months
BASIS-R
Time frame: Change from Baseline to 3 months to 6 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 30 Nov 2018.
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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.
Zlatka Russinova, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery 4 Us in people with Mental Illness and Social Isolation, run by Boston University Charles River Campus at 1 site 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 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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). 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 30 Nov 2018.