Testing a Self-Management App for Symptoms of Posttraumatic Stress

NCT ID: NCT04155736

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-11
• Study Completion Date: 2021-02-06

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Renew with coaching

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).

Group Type: EXPERIMENTAL

Renew

Intervention Type: 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).

Renew without coaching

Same as "Renew with coaching" except that the users will not be assigned a study staff member as a support person.

Group Type: ACTIVE_COMPARATOR

Renew

Intervention Type: 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).

Wait list

No intervention is provided

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

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

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen McLean, PhD

Role: PRINCIPAL_INVESTIGATOR

Palo Alto Veterans Institute for Research

Locations

VA Palo Alto Healthcare System

Menlo Park, California, United States

Countries

United States

References

McLean C, Davis CA, Miller M, Ruzek J, Neri E. The Effects of an Exposure-Based Mobile App on Symptoms of Posttraumatic Stress Disorder in Veterans: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Nov 4;10(11):e38951. doi: 10.2196/38951.

Reference Type: DERIVED

PMID: 36331540 (View on PubMed)

Other Identifiers

52829

Identifier Type: -

Identifier Source: org_study_id