Testing a Self-Management App for Symptoms of Posttraumatic Stress

Not Applicable

Completed

• Conditions: PTSD
• Interventions: Behavioral: Renew

• Registration Number: NCT04155736
• Lead Sponsor: Palo Alto Veterans Institute for Research

Brief Summary

The purpose of this study is to evaluate the acceptability and efficacy of a self-guided behavioral health tool delivered by mobile app (called "Renew") for people who are experiencing symptoms of posttraumatic stress. This study also aims to determine the necessity of coaching support over and above support from peers, shedding light on the critical question of level of support resources needed to maintain mHealth app engagement.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Study Start: 2020-07-11
• Primary Completion: 2021-02-06
• Study Completion: 2021-02-06
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Veterans 18 years or older
• own an Android smart phone (as the app is only available for Android)
• self-report having experiencing symptoms of posttraumatic stress (defined as a PCL-5 score of 31 or higher).

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renew without coaching	Renew	Same as "Renew with coaching" except that the users will not be assigned a study staff member as a support person.
Renew with coaching	Renew	Users will be assigned a study staff member as a support person who is notified when the user engages with the app or if they have not engaged for 7 days. Support persons are provided with psychoeducation material including information about how to be an effective support person for the user and direct messaging capacity to respond to app notifications about user engagement (e.g., user earned X points, user achieved a new level).

Primary Outcome Measures

Name	Time	Method
Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)	Approximately 10-weeks after participant enrollment	Self report measure of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate greater PTSD severity.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)	Approximately 10-weeks after participant enrollment	Self report measure of depression symptoms. It is the 9-item measure that yields a total score of 0-27, with higher scores indicating greater depressive symptom severity.
A PTSD coping self-efficacy measure, developed following Bandura's (2006) guidelines	Approximately 10-weeks after participant enrollment	Self report measure of PTSD coping self-efficacy. It is a 10-item measure that yields a total score of 0-1000, with higher scores indicating greater coping self-efficacy.
Perceived helpfulness of Renew	Approximately 6-weeks after participant enrollment	Phone interview to assess perceived helpfulness of Renew. This is a qualitative measure.
Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet, & Farley, (1988)	Approximately 10-weeks after participant enrollment	Self report measure of perceived social support. It is a 12-item measure that yields a total score of 12-84, with higher scores indicating greater perceived social support.

Trial Locations

Locations (1)

VA Palo Alto Healthcare System; 🇺🇸 Menlo Park, California, United States