NCT02986945

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2017

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

December 1, 2016

Last Update Submit

April 15, 2019

Conditions

Keywords

Depressive symptomsresiliencyHealth Promotionminority healthtext-messaging appparticipatory technology development

Outcome Measures

Primary Outcomes (1)

  • Depressive symptom count as measured by the Patient Health Questionnaire 8

    The Patient Health Questionnaire (PHQ) 8 is a standard measure of depressive symptoms.

    Change from baseline at 1 month

Other Outcomes (8)

  • Fordyce Emotions Questionnaire

    Change from baseline at 1 month

  • Brief Resilience Scale

    Change from baseline at 1 month

  • Coping Strategies

    Change from baseline at 1 month

  • +5 more other outcomes

Study Arms (2)

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.

Behavioral: Resiliency App

Delayed

OTHER

Resiliency App: The Delayed arm will receive the intervention after the Immediate Arm completes its use of the intervention.

Behavioral: Resiliency App

Interventions

Resiliency AppBEHAVIORAL
Also known as: B-RESILIENT
DelayedImmediate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy African American Families

Los Angeles, California, 90008, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jennifer O'Hora, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 8, 2016

Study Start

December 1, 2016

Primary Completion

March 28, 2017

Study Completion

March 28, 2017

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations