Testing a Self-Management App for Symptoms of Posttraumatic Stress

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04155736
• Other study ID #: 52829
• Status: Completed
• Phase: N/A
• Start date: July 11, 2020
• Est. completion date: February 6, 2021

Study information

• Verified date: March 2021
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 6, 2021
• Est. primary completion date: February 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Renew
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).

Locations

Country	Name	City	State
United States	VA Palo Alto Healthcare System	Menlo Park	California

Sponsors (1)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)	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.	Approximately 10-weeks after participant enrollment
Secondary	Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)	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.	Approximately 10-weeks after participant enrollment
Secondary	A PTSD coping self-efficacy measure, developed following Bandura's (2006) guidelines	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.	Approximately 10-weeks after participant enrollment
Secondary	Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet, & Farley, (1988)	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.	Approximately 10-weeks after participant enrollment
Secondary	Perceived helpfulness of Renew	Phone interview to assess perceived helpfulness of Renew. This is a qualitative measure.	Approximately 6-weeks after participant enrollment