Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04769986 |
| Other study ID # |
1R34AA027845-01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
August 31, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University of Southern California |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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
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.
