Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD
This study is testing a new virtual intervention called Managing Physical Reactions to Overwhelming Emotions (IMPROVE) to see if it can help people reduce heavy alcohol use while they are also receiving medication for opioid use disorder (MOUD). IMPROVE is a three-session program delivered online with a mobile app. Researchers want to know if IMPROVE is better at reducing daily alcohol use and improving MOUD adherence compared to a health education training (HET) program, which also involves three virtual sessions and a mobile app. You might be able to join if you are 18 or older, have recently started an outpatient MOUD program, and are a heavy alcohol user. Success in this study will be measured by changes in alcohol use, how you react to stress, and your self-reported intolerance of uncertainty after 4 weeks.
- Study design
- This is an interventional study with a planned enrollment of 80 participants. Participants will be randomized to either the IMPROVE intervention or the Health Education Training (HET) control group.
- What's involved
- Participants will complete a baseline electroencephalography (EEG) and self-report questionnaires. They will then participate in three virtual sessions and use a mobile application.
- Compensation
- Not stated in the trial record.
- Follow-up
- Alcohol use, startle eyeblink potentiation, and self-reported intolerance of uncertainty will be measured at 4 weeks post-treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Alcohol UseChange from baseline to post-treatment (week 4)
Changes in proportion of heavy drinking days and drinks per drinking day following the intervention.
- Startle eyeblink potentiation during unpredictable threatChange from baseline to post-treatment (week 4)
Startle eyeblink potentiation will be collected during the No-, Predictable-, Unpredictable -Threat (NPU) startle paradigm. Startle is a cross-species index of aversive reactivity. Startle during unpredictable threat is an objective indicator of response to uncertain stress.
- Self-reported Intolerance of UncertaintyChange from baseline to post-treatment (week 4)
The Intolerance of Uncertainty- Short Form is a gold-standard self-report assessment. Subscale scores on the measure range from 7-35 for 'prospective intolerance of uncertainty' and 5-25 for 'inhibitory intolerance of uncertainty', with higher scores indicating greater intolerance of uncertainty.
- Late positive potential when viewing anxiety sensitivity evoking imagesChange from baseline to post-treatment (week 4)
The late positive potential will be collected from the emotional picture paradigm. The late positive potential captures emotional reactivity. Emotional reactivity to a battery of anxiety sensitivity-evoking images is an objective indicator of response to bodily anxiety sensations.
- Self-reported Anxiety SensitivityChange from baseline to post-treatment (week 4)
The Anxiety Sensitivity Index-3 scale is a gold standard self-report assessment. Scores range from 0 to 72 where higher scores indicate higher anxiety sensitivity.