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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

Tracking Information
First Submitted Date  ICMJE October 30, 2019
First Posted Date  ICMJE November 7, 2019
Last Update Posted Date November 7, 2019
Estimated Study Start Date  ICMJE January 2020
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testing a Self-Management App for Symptoms of Posttraumatic Stress
Official Title  ICMJE A Randomized Controlled Trial of a Self-Management App for Symptoms of Posttraumatic Stress: The Role of Coaching Support
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: Renew
  • 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.
    Intervention: Behavioral: Renew
  • No Intervention: Wait list
    No intervention is provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carmen McLean, PhD (650) 614-9997 carmen.mclean4@va.gov
Contact: Madeleine Miller, BS (650) 614-9997 Madeleine.Miller@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04155736
Other Study ID Numbers  ICMJE 52829
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Palo Alto Veterans Institute for Research
Study Sponsor  ICMJE Palo Alto Veterans Institute for Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carmen McLean, PhD Palo Alto Veterans Institute for Research
PRS Account Palo Alto Veterans Institute for Research
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP