Mobile Mindfulness for Alcohol Use and PTSD Among Veterans
Primary Purpose
Alcohol Use Disorder, Posttraumatic Stress Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Mindfulness-Relapse Prevention (mMBRP)
Exercise/healthy eating mobile app
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Veterans, Mindfulness, Alcohol
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;
Sites / Locations
- University of Southern CaliforniaRecruiting
- National Center for PTSD
- San Francisco Veterans Affairs Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mobile Mindfulness-Based Relapse Prevention (mMBRP)
Active control
Arm Description
Participants will complete the Mindfulness Coach app program that is enhanced with additional modules containing MBRP content.
Participants will complete a course of an exercise/healthy eating app program that is matched in time and effort to the intervention condition app.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
change in Treatment engagement
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.
Full Information
NCT ID
NCT04769986
First Posted
February 17, 2021
Last Updated
April 18, 2023
Sponsor
University of Southern California
Collaborators
San Francisco Veterans Affairs Medical Center, National Center for PTSD
1. Study Identification
Unique Protocol Identification Number
NCT04769986
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
San Francisco Veterans Affairs Medical Center, National Center for PTSD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Posttraumatic Stress Disorder
Keywords
Veterans, Mindfulness, Alcohol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mobile Mindfulness-Based Relapse Prevention (mMBRP)
Arm Type
Experimental
Arm Description
Participants will complete the Mindfulness Coach app program that is enhanced with additional modules containing MBRP content.
Arm Title
Active control
Arm Type
Active Comparator
Arm Description
Participants will complete a course of an exercise/healthy eating app program that is matched in time and effort to the intervention condition app.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Mindfulness-Relapse Prevention (mMBRP)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Exercise/healthy eating mobile app
Intervention Description
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 Measure Information:
Title
change in PTSD symptoms
Description
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 Frame
Time 1: baseline; Time 2: 4 week; Time 3: 8 week; Time 4: 12 week; Time 5: 16 week
Title
change in Alcohol use and related problems
Description
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 Frame
Time 1: baseline; Time 2: 4 week; Time 3: 8 week; Time 4: 12 week; Time 5: 16 week
Secondary Outcome Measure Information:
Title
change in Treatment engagement
Description
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.
Time Frame
Screening in beta test; Time 1: baseline; Time 2: 4 week; Time 3: 8 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan P Davis, PhD
Phone
334.332.0523
Email
jordanpd@usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eric R Pedesen, PhD
Phone
(323) 442-4046
Email
Eric.Pedersen@med.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan P Davis, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric R Pedersen, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan P Davis, PhD
Phone
213-740-8311
Email
jordanpd@usc.edu
First Name & Middle Initial & Last Name & Degree
Eric R Pedersen, PhD
Phone
(323) 442-4046
Email
Eric.Pedersen@med.usc.edu
Facility Name
National Center for PTSD
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Owen, PhD
Phone
650-493-5000
Email
jason.owen@va.gov
First Name & Middle Initial & Last Name & Degree
Beth Jaworski, PhD
Phone
650-493-5000
Email
beth.jaworski@va.gov
Facility Name
San Francisco Veterans Affairs Healthcare System
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Borsari, PhD
Phone
415-221-4810
Email
Brian.Borsari@va.gov
12. IPD Sharing Statement
Plan to Share IPD
No
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Mobile Mindfulness for Alcohol Use and PTSD Among Veterans
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