NCT04155736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

July 11, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

October 30, 2019

Last Update Submit

March 24, 2021

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

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

    Approximately 10-weeks after participant enrollment

  • Perceived helpfulness of Renew

    Approximately 6-weeks after participant enrollment

Study Arms (3)

Renew with coaching

EXPERIMENTAL

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).

Behavioral: Renew

Renew without coaching

ACTIVE COMPARATOR

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

Behavioral: Renew

Wait list

NO INTERVENTION

No intervention is provided

Interventions

RenewBEHAVIORAL

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 with coachingRenew without coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Healthcare System

Menlo Park, California, 94025, United States

Location

Related Publications (1)

  • 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.

    PMID: 36331540DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Carmen McLean, PhD

    Palo Alto Veterans Institute for Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 7, 2019

Study Start

July 11, 2020

Primary Completion

February 6, 2021

Study Completion

February 6, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)