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Testing a Self-Management App for Symptoms of Posttraumatic Stress

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ClinicalTrials.gov Identifier: NCT04155736
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Palo Alto Veterans Institute for Research

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.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: Renew Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Self-Management App for Symptoms of Posttraumatic Stress: The Role of Coaching Support
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: 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).
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).

Active Comparator: Renew without coaching
Same as "Renew with coaching" except that the users will not be assigned a study staff member as a support person.
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).

No Intervention: Wait list
No intervention is provided



Primary Outcome Measures :
  1. Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013) [ Time Frame: Approximately 10-weeks after participant enrollment ]
    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.


Secondary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001) [ Time Frame: Approximately 10-weeks after participant enrollment ]
    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.

  2. A PTSD coping self-efficacy measure, developed following Bandura's (2006) guidelines [ Time Frame: Approximately 10-weeks after participant enrollment ]
    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.

  3. Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet, & Farley, (1988) [ Time Frame: Approximately 10-weeks after participant enrollment ]
    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.

  4. Perceived helpfulness of Renew [ Time Frame: Approximately 6-weeks after participant enrollment ]
    Phone interview to assess perceived helpfulness of Renew. This is a qualitative measure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155736


Contacts
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Contact: Carmen McLean, PhD (650) 614-9997 carmen.mclean4@va.gov
Contact: Madeleine Miller, BS (650) 614-9997 Madeleine.Miller@va.gov

Locations
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United States, California
VA Palo Alto Healthcare System Not yet recruiting
Menlo Park, California, United States, 94025
Contact: Carmen McLean, PhD    650-614-9997    carmen.mclean4@va.gov   
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
Investigators
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Principal Investigator: Carmen McLean, PhD Palo Alto Veterans Institute for Research

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Responsible Party: Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT04155736     History of Changes
Other Study ID Numbers: 52829
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No