Clinical trial NCT04769986: Mobile Mindfulness for Alcohol Use and PTSD Among Veterans
Official title: Development of a Mobile Mindfulness Intervention for Alcohol Use Disorder and PTSD Among OEF/OIF Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Posttraumatic Stress Disorder
Keywords: Veterans
Mindfulness
Alcohol
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: San Francisco Veterans Affairs Medical Center
name: National Center for PTSD
First posted: 2021-02-25
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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;

Primary outcomes:
measure: change in PTSD symptoms
timeFrame: Time 1: baseline; Time 2: 4 week; Time 3: 8 week; Time 4: 12 week; Time 5: 16 week
measure: change in Alcohol use and related problems
timeFrame: Time 1: baseline; Time 2: 4 week; Time 3: 8 week; Time 4: 12 week; Time 5: 16 week
Secondary outcomes:
measure: change in Treatment engagement
timeFrame: Screening in beta test; Time 1: baseline; Time 2: 4 week; Time 3: 8 week
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Menlo Park
country: United States
facility: National Center for PTSD
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Healthcare System
state: California
Study officials:
affiliation: RAND
name: Jordan P Davis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Eric R Pedersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: