跳至主要内容
临床试验/NCT02986945
NCT02986945已完成不适用

Community-Partnered Participatory Development of Mobile Interventions

RAND2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
30
试验地点
2
主要终点
Depressive symptom count as measured by the Patient Health Questionnaire 8

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Resiliency App (Behavioral)

Delayed

Other

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

干预措施: Resiliency App (Behavioral)

结局指标

主要结局

Depressive symptom count as measured by the Patient Health Questionnaire 8

时间窗: Change from baseline at 1 month

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

次要结局

未报告次要终点

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验