Skip to content

Testing a Self-Management App for Symptoms of Posttraumatic Stress

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04155736
Enrollment
100
Registered
2019-11-07
Start date
2020-07-11
Completion date
2021-02-06
Last updated
2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

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.

Interventions

BEHAVIORALRenew

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).

Sponsors

Palo Alto Veterans Institute for Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)Approximately 10-weeks after participant enrollmentSelf 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

MeasureTime frameDescription
Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)Approximately 10-weeks after participant enrollmentSelf 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) guidelinesApproximately 10-weeks after participant enrollmentSelf 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.
Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet, & Farley, (1988)Approximately 10-weeks after participant enrollmentSelf 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.
Perceived helpfulness of RenewApproximately 6-weeks after participant enrollmentPhone interview to assess perceived helpfulness of Renew. This is a qualitative measure.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026