Depressive SymptomsNCT02986945
Community-Partnered Participatory Development of Mobile Interventions
A study testing Resiliency App in people with Depressive Symptoms, run by RAND at 1 site in United States.
Trial summary
The purpose of the study is to test an experimental method, a text-messaging app called B-RESILIENT, for improving participants' mood. B-RESILIENT is a text messaging app adaptation of a Resiliency Course, developed by community members known as Building Resiliency and Community Hope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Resiliency App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 28 Mar 2017
- 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
- Age 18 or older
- Speak English
- Endorse one item on the PHQ-2
- Are able to be contacted by phone or email, and have a cell phone that receives text messages
- Have internet access
Who cannot join
- Under age 18 years
- Endorse no items on PHQ-2 screener
- PHQ-8 score of 15 or greater on the baseline interview
- No cell phone and internet access
- Currently homeless
- Has a prior diagnosis of schizophrenia, psychosis, bipolar disorder
- Current alcohol and substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy African American Families
Los Angeles, California, 90008
About this study
The purpose of the study is to test an experimental method, a text-messaging app called B-RESILIENT, for improving participants' mood. B-RESILIENT is a text messaging app adaptation of a Resiliency Course, developed by community members known as Building Resiliency and Community Hope.
Read the detailed description
In phase 1, the investigators held a series of in-person and virtual workshops with the Partnered Research Center for Quality Care (PRC) community partners to co-develop mobile interventions to address community priorities. The goal of the workshops was to develop novel mobile interventions based on stakeholder input. The specific intervention to be developed was determined based on stakeholder input regarding community priorities during the workshops. Workshops were audio and/or video recorded to document the process. One of the tools used in this process was the Chorus Participatory Mobile Framework created at the Center for Health Services and Society at UCLA. Chorus is a web application that allows users to easily create mobile (text messaging and interactive voice) applications in real-time without requiring any server programming. The investigators used this framework during the workshops to develop and test the application in real-time. Participants were also given phone numbers to call or text in to the intervention that they co-developed for the purpose of testing, providing feedback, and guiding future development.
In phase 2, the investigators will conduct a pilot randomized control trial of the B-RESILIENT tool developed during the workgroup phase 1. Investigators will enroll 30 adults in South Los Angeles to participate in a randomized, wait-list trial. The study group will receive the intervention for 4 weeks, followed by the wait-list group for another 4 weeks. Investigators will conduct baseline and follow-up surveys, as well as in-person or telephone workgroups, to assess the tool's usability and feasibility for supporting management of mood and depressive symptoms.
- Conditions
- Depressive Symptoms
- Being tested
- Resiliency App
- Keywords
- Depressive symptoms, resiliency, Health Promotion, minority health, text-messaging app, participatory technology development
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resiliency AppBehavioural
Also called B-RESILIENT
| Study group | Role | What they receive |
|---|---|---|
| Immediate | Experimental | Resiliency App: Study participants randomized to the Immediate group will receive the text-messaging app, B-RESILIENT-an adaptation of a Resiliency Course for improving mood in individuals with depressive symptoms--for 4 weeks.
Wk 1: BOOST - manage unhealthy thoughts. Wk 2: BREAK - doing pleasant activities. Wk 3: BUDDY - effective communication for social support. Wk 4: Review of first 3 weeks. Each day, users will receive a daily affirmation text message, a series of approximately 5-10 text messages on the topic of the day, and a daily goal corresponding to the day's content (e.g. do a pleasant activity). At the end of the day, users will receive text messages asking them to report whether they completed the daily goal, followed by a daily mood measure. Receives: Behavioral: Resiliency App |
| Delayed | Other | Resiliency App: The Delayed arm will receive the intervention after the Immediate Arm completes its use of the intervention. Receives: Behavioral: Resiliency App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptom count as measured by the Patient Health Questionnaire 8
The Patient Health Questionnaire (PHQ) 8 is a standard measure of depressive symptoms.
Measured: Change from baseline at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start1 Dec 2016
- Primary completion28 Mar 2017
- Study completion28 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Jennifer O'Hora, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986945
- Sponsor's protocol ID
- RHINO 2013-0834
- Status last verified
- Apr 2019
- First submitted
- 1 Dec 2016
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Partnered Participatory Development of Mobile Interventions
- ClinicalTrials.gov ID
- NCT02986945
- Acronym / sponsor ID
- RHINO 2013-0834
- Conditions
- Depressive Symptoms
- Keywords
- Depressive symptoms, resiliency, Health Promotion, minority health, text-messaging app, participatory technology development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 28 Mar 2017 (actual)
- First posted
- 8 Dec 2016 (estimated)
- 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 the study is to test an experimental method, a text-messaging app called B-RESILIENT, for improving participants' mood. B-RESILIENT is a text messaging app adaptation of a Resiliency Course, developed by community members known as Building Resiliency and Community Hope.
Detailed description
In phase 1, the investigators held a series of in-person and virtual workshops with the Partnered Research Center for Quality Care (PRC) community partners to co-develop mobile interventions to address community priorities. The goal of the workshops was to develop novel mobile interventions based on stakeholder input. The specific intervention to be developed was determined based on stakeholder input regarding community priorities during the workshops. Workshops were audio and/or video recorded to document the process. One of the tools used in this process was the Chorus Participatory Mobile Framework created at the Center for Health Services and Society at UCLA. Chorus is a web application that allows users to easily create mobile (text messaging and interactive voice) applications in real-time without requiring any server programming. The investigators used this framework during the workshops to develop and test the application in real-time. Participants were also given phone numbers to call or text in to the intervention that they co-developed for the purpose of testing, providing feedback, and guiding future development.
In phase 2, the investigators will conduct a pilot randomized control trial of the B-RESILIENT tool developed during the workgroup phase 1. Investigators will enroll 30 adults in South Los Angeles to participate in a randomized, wait-list trial. The study group will receive the intervention for 4 weeks, followed by the wait-list group for another 4 weeks. Investigators will conduct baseline and follow-up surveys, as well as in-person or telephone workgroups, to assess the tool's usability and feasibility for supporting management of mood and depressive symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate | Experimental | Behavioral: Resiliency AppResiliency App: Study participants randomized to the Immediate group will receive the text-messaging app, B-RESILIENT-an adaptation of a Resiliency Course for improving mood in individuals with depressive symptoms--for 4 weeks. Wk 1: BOOST - manage unhealthy thoughts. Wk 2: BREAK - doing pleasant activities. Wk 3: BUDDY - effective communication for social support. Wk 4: Review of first 3 weeks. Each day, users will receive a daily affirmation text message, a series of approximately 5-10 text messages on the topic of the day, and a daily goal corresponding to the day's content (e.g. do a pleasant activity). At the end of the day, users will receive text messages asking them to report whether they completed the daily goal, followed by a daily mood measure. |
| Delayed | Other | Behavioral: Resiliency AppResiliency App: The Delayed arm will receive the intervention after the Immediate Arm completes its use of the 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)
- Age 18 or older
- Speak English
- Endorse one item on the PHQ-2
- Are able to be contacted by phone or email, and have a cell phone that receives text messages
- Have internet access
Key exclusion criteria (7 listed)
- Under age 18 years
- Endorse no items on PHQ-2 screener
- PHQ-8 score of 15 or greater on the baseline interview
- No cell phone and internet access
- Currently homeless
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 |
|---|---|---|
| Resiliency AppAlso: B-RESILIENT | Behavioural | Delayed, Immediate |
Primary outcome
Depressive symptom count as measured by the Patient Health Questionnaire 8
Time frame: Change from baseline at 1 month
The Patient Health Questionnaire (PHQ) 8 is a standard measure of depressive symptoms.
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 17 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Jennifer O'Hora, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resiliency App in people with Depressive Symptoms, run by RAND 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 7 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 17 Apr 2019. 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?
Depressive symptom count as measured by the Patient Health Questionnaire 8 (time frame: Change from baseline at 1 month). 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 17 Apr 2019.