Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Wait list | No Intervention | No intervention is provided |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| A PTSD coping self-efficacy measure, developed following Bandura's (2006) guidelines |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carmen McLean, PhD | Palo Alto Veterans Institute for Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Healthcare System | Menlo Park | California | 94025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39036876 | Derived | Davis CA, Miller M, McLean CP. The Impact of User Engagement With Exposure Components on Posttraumatic Stress Symptoms in an mHealth Mobile App: Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jul 18;12:e49393. doi: 10.2196/49393. | |
| 36331540 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| 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 |
| Perceived helpfulness of Renew | Phone interview to assess perceived helpfulness of Renew. This is a qualitative measure. | Approximately 6-weeks after participant enrollment |