Mobile Mindfulness for Alcohol Use and PTSD Among Veterans

NCT04769986 | Completed DMC

• 1 other identifier: 1R34AA027845-01
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 3

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

Conditions

Alcohol Use Disorder; Posttraumatic Stress Disorder

Keywords

Veterans; Mindfulness; Alcohol

Outcome Measures

Primary Outcomes (2)

• change in PTSD symptoms

  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.

  Time 1: baseline; Time 2: 4 week; Time 3: 8 week; Time 4: 12 week; Time 5: 16 week

• change in Alcohol use and related problems

  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.

  Time 1: baseline; Time 2: 4 week; Time 3: 8 week; Time 4: 12 week; Time 5: 16 week

Secondary Outcomes (1)

• change in Treatment engagement

  Screening in beta test; Time 1: baseline; Time 2: 4 week; Time 3: 8 week

Study Arms (2)

Mobile Mindfulness-Based Relapse Prevention (mMBRP)

EXPERIMENTAL

Participants will complete the Mindfulness Coach app program that is enhanced with additional modules containing MBRP content.

Behavioral: Mobile Mindfulness-Relapse Prevention (mMBRP)

Active control

ACTIVE COMPARATOR

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

Interventions

Mobile Mindfulness-Relapse Prevention (mMBRP) BEHAVIORAL

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).

Mobile Mindfulness-Based Relapse Prevention (mMBRP)

Exercise/healthy eating mobile app BEHAVIORAL

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.

Active control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Southern California: lead
• San Francisco Veterans Affairs Medical Center: collaborator
• National Center for PTSD: collaborator

Study Sites (3)

University of Southern California

Los Angeles, California, 90089, United States

Location

National Center for PTSD

Menlo Park, California, 94025, United States

Location

San Francisco Veterans Affairs Healthcare System

San Francisco, California, 94121, United States

Location

Related Publications (1)

• Davis JP, Pedersen ER, Borsari B, Bowen S, Owen J, Sedano A, Fitzke R, Delacruz J, Tran DD, Buch K, Saba S, Canning L, Bunyi J. Development of a mobile mindfulness smartphone app for post-traumatic stress disorder and alcohol use problems for veterans: Beta test results and study protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2023 Jun;129:107181. doi: 10.1016/j.cct.2023.107181. Epub 2023 Apr 12.

  PMID: 37059261 DERIVED

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jordan P Davis, PhD

  RAND

  PRINCIPAL INVESTIGATOR

• Eric R Pedersen, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and the Behavioral Sciences and Population and Public Health Sciences

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 25, 2021
• Study Start: January 1, 2021
• Primary Completion: January 15, 2024
• Study Completion: August 31, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)