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Clinical Trials/NCT04155736
NCT04155736
Completed
Not Applicable

A Randomized Controlled Trial of a Self-Management App for Symptoms of Posttraumatic Stress: The Role of Coaching Support

Palo Alto Veterans Institute for Research1 site in 1 country100 target enrollmentJuly 11, 2020
ConditionsPTSD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PTSD
Sponsor
Palo Alto Veterans Institute for Research
Enrollment
100
Locations
1
Primary Endpoint
Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 11, 2020
End Date
February 6, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)

Time Frame: 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 Outcomes

  • Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)(Approximately 10-weeks after participant enrollment)
  • A PTSD coping self-efficacy measure, developed following Bandura's (2006) guidelines(Approximately 10-weeks after participant enrollment)
  • Perceived helpfulness of Renew(Approximately 6-weeks after participant enrollment)
  • Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet, & Farley, (1988)(Approximately 10-weeks after participant enrollment)

Study Sites (1)

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