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OpenTrials
Completed

NCT Number: NCT04155736

Testing a Self-Management App for Symptoms of Posttraumatic Stress

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Healthcare System

Menlo Park, California, 94025, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RENEW

Behavioral

Renew is a behavioral health self-management app/too that focuses on three core activities: 1) in vivo exposure (to help participants approach safe situations they have been avoiding that they want to feel comfortable in), 2) expressive writing (to help participants emotionally process trauma memories), and 3) Self-Care exercises (designed to promote behavioral activation, social connectedness and relaxation; includes a breathing relaxation tool). Users have access to psychoeducation via a whiteboard video and short texts as well as Motivation content (quotes, videos, images, and songs) related to confronting challenges and overcoming fears. For each exercise that is completed, the user earns points that are connected to levels and visually reinforcing images (i.e., a growing tree).

Primary outcomes

  1. 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

  1. Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)

    Time frame: 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.

  2. A PTSD coping self-efficacy measure, developed following Bandura's (2006) guidelines

    Time frame: 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.

  3. Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet, & Farley, (1988)

    Time frame: 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.

  4. Perceived helpfulness of Renew

    Time frame: Approximately 6-weeks after participant enrollment

    Phone interview to assess perceived helpfulness of Renew. This is a qualitative measure.

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 7, 2019
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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