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.|
|ClinicalTrials.gov Identifier: NCT04769986|
Recruitment Status : Not yet recruiting
First Posted : February 25, 2021
Last Update Posted : February 25, 2021
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
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): NCT04769986
|Contact: Jordan P Davis, PhDfirstname.lastname@example.org|
|Contact: Eric R Pedesen, PhD||(323) 442-4046||Eric.Pedersen@med.usc.edu|
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90089|
|Contact: Jordan P Davis, PhD 213-740-8311 email@example.com|
|Contact: Eric R Pedersen, PhD (323) 442-4046 Eric.Pedersen@med.usc.edu|
|National Center for PTSD|
|Menlo Park, California, United States, 94025|
|Contact: Jason Owen, PhD 650-493-5000 firstname.lastname@example.org|
|Contact: Beth Jaworski, PhD 650-493-5000 email@example.com|
|San Francisco Veterans Affairs Healthcare System|
|San Francisco, California, United States, 94121|
|Contact: Brian Borsari, PhD 415-221-4810 Brian.Borsari@va.gov|
|Principal Investigator:||Jordan P Davis, PhD||University of Southern California|
|Principal Investigator:||Eric R Pedersen, PhD||University of Southern California|