Alcohol Use DisorderNCT04769986
Mobile Mindfulness for Alcohol Use and PTSD Among Veterans
A study testing Mobile Mindfulness-Relapse Prevention (mMBRP) and Exercise/healthy eating mobile app in people with Alcohol Use Disorder and Posttraumatic Stress Disorder, run by University of Southern California at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Posttraumatic Stress Disorder
- What is being tested?
- Mobile Mindfulness-Relapse Prevention (mMBRP) and Exercise/healthy eating mobile app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2021to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Southern California
Los Angeles, California, 90089
National Center for PTSD
Menlo Park, California, 94025
San Francisco Veterans Affairs Healthcare System
San Francisco, California, 94121
About this study
Official title: Development of a Mobile Mindfulness Intervention for Alcohol Use Disorder and PTSD Among OEF/OIF Veterans
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
Read the 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.
- Being tested
- Mobile Mindfulness-Relapse Prevention (mMBRP), Exercise/healthy eating mobile app
- Keywords
- Veterans, Mindfulness, Alcohol
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Mindfulness-Relapse Prevention (mMBRP)Behavioural
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).
Exercise/healthy eating mobile appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Mindfulness-Based Relapse Prevention (mMBRP) | Experimental | Participants will complete the Mindfulness Coach app program that is enhanced with additional modules containing MBRP content. Receives: 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. Receives: Behavioral: Exercise/healthy eating mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Screening in beta test; Time 1: baseline; Time 2: 4 week; Time 3: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Jan 2021
- Primary completion15 Jan 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center, National Center for PTSD
- Responsible party
- Principal investigator, Eric Pedersen, University of Southern California
- Investigators
- Jordan P Davis, PhD, Principal investigator, RANDEric R Pedersen, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769986
- Sponsor's protocol ID
- 1R34AA027845-01
- Status last verified
- May 2024
- First submitted
- 17 Feb 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37059261
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Mobile Mindfulness Intervention for Alcohol Use Disorder and PTSD Among OEF/OIF Veterans
- ClinicalTrials.gov ID
- NCT04769986
- Acronym / sponsor ID
- 1R34AA027845-01
- Keywords
- Veterans, Mindfulness, Alcohol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center, National Center for PTSD
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Mindfulness-Based Relapse Prevention (mMBRP) | Experimental | Behavioral: Mobile Mindfulness-Relapse Prevention (mMBRP)Participants will complete the Mindfulness Coach app program that is enhanced with additional modules containing MBRP content. |
| Active control | Active comparator | Behavioral: Exercise/healthy eating mobile appParticipants will complete a course of an exercise/healthy eating app program that is matched in time and effort to the intervention condition app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Mobile Mindfulness-Based Relapse Prevention (mMBRP) |
| Exercise/healthy eating mobile appParticipants 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. | Behavioural | Active control |
Primary outcome
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.
1 secondary outcome
change in Treatment engagement
Time frame: Screening in beta test; Time 1: baseline; Time 2: 4 week; Time 3: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Derived from this study: PubMed 37059261Davis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan P Davis, PhD principal investigator
RAND
Eric R Pedersen, PhD principal investigator
University of Southern California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Mindfulness-Relapse Prevention (mMBRP) and Exercise/healthy eating mobile app in people with Alcohol Use Disorder and Posttraumatic Stress Disorder, run by University of Southern California at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04769986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.