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Mobile Mindfulness for Alcohol Use and PTSD Among Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04769986
Recruitment Status : Not yet recruiting
First Posted : February 25, 2021
Last Update Posted : February 25, 2021
San Francisco Veterans Affairs Medical Center
National Center for PTSD
Information provided by (Responsible Party):
Jordan Davis, University of Southern California

Brief Summary:
The purpose of the present study is to develop and test a mobile mindfulness intervention for Alcohol Use Disorder and PTSD among OEF/OIF veterans

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Posttraumatic Stress Disorder Behavioral: Mobile Mindfulness-Relapse Prevention (mMBRP) Behavioral: Exercise/healthy eating mobile app Not Applicable

Detailed Description:
The long-term goal of this proposal is to improve treatment outcomes for OEF/OIF(Operation Enduring Freedom/Operation Iraqi Freedom) veterans with alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) who are not currently accessing care through the Veterans Affairs Healthcare System (VA) or other settings. Many OEF/OIF veterans struggle with heavy drinking and related consequences and this can be especially pronounced with the co-occurrence of PTSD. Prior research has found aspects of self-regulation (emotion regulation, impulse control), stress, and craving to be important putative targets in AUD and PTSD symptom reduction. However, with upwards of 50% of veterans who have behavioral health needs not seeking treatment, it is imperative to utilize advances in technology to develop and test interventions that can reach non-treatment seeking veterans and target both symptoms of PTSD and AUD. As the proposed mechanisms (e.g., self-regulation) are becoming better understood regarding how they affect PTSD and AUD outcomes, approaches should focus on targeting these mechanisms and evaluating if they are essential facilitators of change. Mindfulness-based interventions (MBI) can target such mechanisms, but a gap in the knowledge persists regarding the utility of MBIs with veterans who screen positive for PTSD and AUD. Therefore, we propose to improve treatment outcomes for OEF/OIF veterans with PTSD and AUD by targeting self-regulation, stress, and cravings. We will develop and test a novel mobile MBI, Mobile Mindfulness Based Relapse Prevention (mMBRP), that will improve upon evidence based in-person and group MBRP by reaching veterans outside of treatment settings. The engaging and easy to use mobile MBI integrates relapse prevention, stress reduction, and self-regulation skills and is relevant to issues surrounding stigma and barriers that veterans face when seeking services. The central hypothesis will be tested through a focus on three specific aims: (1) refine and add MBRP content to the popular VA developed Mindfulness Coach mobile application through a beta testing phase where we test for feasibility and acceptability of the app, (2) pilot test the efficacy of the mMBRP mobile app on alcohol use and PTSD outcomes compared to control, and (3) assess mechanisms of change such as self-regulation, stress, and cravings, as well as exploratory moderators of gender, race/ethnicity, and recency of discharge, on mMBRP effects. The unique strengths of this proposal are its focus on an underserved population, utilization of mobile technology for intervention delivery, and use of a novel intervention known to effectively target self-regulation and stress. The expected results will define a viable and easy-to-access treatment that can improve both AUD and PTSD symptoms. Results of this study will have a positive impact on substance use outcomes for those who have experienced traumatic events and will identify mechanism of action for treatment success. The app can be disseminated through our partners in the VA and through targeted sharing on social media.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of a Mobile Mindfulness Intervention for Alcohol Use Disorder and PTSD Among OEF/OIF Veterans
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Mobile Mindfulness-Based Relapse Prevention (mMBRP)
Participants will complete the Mindfulness Coach app program that is enhanced with additional modules containing MBRP content.
Behavioral: Mobile Mindfulness-Relapse Prevention (mMBRP)
Mindfulness Coach 2.0 is a mobile application designed by the VA's National Center for PTSD. The app provides: (a) psychoeducational topics related to mindfulness; (b) audio-guided mindfulness exercises; (c) self-assessment using the Five Facet Mindfulness Questionnaire (d) a journal to track mindfulness practice sessions; (e) goal setting and tracking; (f) personal, customizable reminders; and (g) immediate access to support and crisis resources. We will enhance Mindfulness Coach with MBRP content by adding information about the triangle of awareness to understand connections among thoughts, sensations, and emotions, and specific meditations of sober breathing space and urge surfing to deal with cravings. We will add additional MBRP-specific modules. Participants will be asked to complete the intervention during 8 weeks, with two to three modules per week. After a beta test with 20 veterans, feedback will be used to refine the app for the national randomized clinical trial (RCT).

Active Comparator: Active control
Participants will complete a course of an exercise/healthy eating app program that is matched in time and effort to the intervention condition app.
Behavioral: Exercise/healthy eating mobile app
Participants in the control condition will be asked to download an exercise/healthy eating mobile app and use it for 8 weeks. Similar to Mindfulness Coach, the app will have specialized self-management guides that follow a guide-per-week format, educational videos that teach diet and exercise strategies, and a diary to track diet and exercise progress.

Primary Outcome Measures :
  1. change in PTSD symptoms [ Time Frame: Time 1: baseline; Time 2: 4 week; Time 3: 8 week; Time 4: 12 week; Time 5: 16 week ]
    The PTSD Checklist is a 20-item self-report measure that assesses the 20 DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) symptoms of PTSD.

  2. change in Alcohol use and related problems [ Time Frame: Time 1: baseline; Time 2: 4 week; Time 3: 8 week; Time 4: 12 week; Time 5: 16 week ]
    Alcohol use will be measured using an online version of the timeline follow back, which will assess past 30 day drinking days and typical drinks per occasion. Number of alcohol consequences experienced in the past month will be assessed with the 24-item Brief Young Adult Alcohol Consequences Questionnaire.

Secondary Outcome Measures :
  1. change in Treatment engagement [ Time Frame: Screening in beta test; Time 1: baseline; Time 2: 4 week; Time 3: 8 week ]
    The Mental Health/Substance Use Disorder Treatment History Inventory will be used to screen in participants who have not used care in the past 6-months as well as examine if participants engage in care during the treatment phase or during the post-treatment phase.

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:   Yes

Inclusion Criteria:

  • veterans aged 18 or older who have separated/discharged from military service from the Air Force, Army, Marine Corps, or Navy;
  • have served as part of Operations Enduring Freedom, Iraqi Freedom, or New Dawn (OEF/OIF/OND)
  • be able to read English
  • own a personal smartphone with Internet access and be interested in using apps on that phone
  • score 8 or higher on the Alcohol Use Disorder Identification Test, which represents probable AUD in civilian and military samples and is the VA's criteria for "severe risk" of AUD warranting referral to a substance use treatment clinic
  • score a 33 or higher on the PTSD check list (PCL-5), which represents probable PTSD diagnosis among OEF/OIF veterans.

Exclusion Criteria:

  • currently affiliated with active duty service or in the reserves or guard units
  • past six-month treatment for alcohol or drug use or PTSD at the Veterans Affairs Healthcare System (VA) or other health care providers or clinics;

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 identifier (NCT number): NCT04769986

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Contact: Jordan P Davis, PhD 334.332.0523
Contact: Eric R Pedesen, PhD (323) 442-4046

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United States, California
University of Southern California
Los Angeles, California, United States, 90089
Contact: Jordan P Davis, PhD    213-740-8311   
Contact: Eric R Pedersen, PhD    (323) 442-4046   
National Center for PTSD
Menlo Park, California, United States, 94025
Contact: Jason Owen, PhD    650-493-5000   
Contact: Beth Jaworski, PhD    650-493-5000   
San Francisco Veterans Affairs Healthcare System
San Francisco, California, United States, 94121
Contact: Brian Borsari, PhD    415-221-4810   
Sponsors and Collaborators
University of Southern California
San Francisco Veterans Affairs Medical Center
National Center for PTSD
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Principal Investigator: Jordan P Davis, PhD University of Southern California
Principal Investigator: Eric R Pedersen, PhD University of Southern California
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Responsible Party: Jordan Davis, Associate Professor, University of Southern California Identifier: NCT04769986    
Other Study ID Numbers: 1R34AA027845-01 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
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
Keywords provided by Jordan Davis, University of Southern California:
Additional relevant MeSH terms:
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Alcohol Drinking
Stress Disorders, Post-Traumatic
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders