Brief Digitally-Enhanced Intervention for Managing Emotional Pain and Reducing Alcohol Use During Medication for OUD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Alcohol Use
研究概览
简要总结
The goal of this clinical trial is to reduce heavy drinking and enhance medication for opioid use disorder (MOUD) outcomes in individuals receiving MOUD. The main questions it aims to answer are:
- Does the brief, digitally-enhanced, virtual psychotherapeutic intervention, called Managing Physical Reactions to Overwhelming Emotions (IMPROVE), impact daily alcohol use and MOUD adherence?
- Does the intervention change self-report and physiological responses to intolerance to uncertainty and anxiety sensitivity?
Researchers will compare IMPROVE to a control intervention (health education treatment) to see if IMPROVE impacts daily alcohol use and MOUD adherence.
Participants will:
- Complete a baseline electroencephalography (EEG) and self-report questionnaires.
- Complete three one-hour intervention sessions (IMPROVE or control) each one week a part.
- Complete a post-intervention EEG and self-report questionnaires.
- Complete five ecological momentary assessment (EMA) surveys a day for 21 days.
- Complete self-report questionnaires one-month after their last intervention session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be blind to the condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in outpatient medication for opioid use disorder (MOUD) program (within the past month)
- •Heavy alcohol user defined using the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria (i.e., consume 8+/15+ drinks per week [women/men] with at least two binge episodes [4/5+ drinks for women/men in a 2 hour period] in the past month)
- •Elevated psychological distress defined as a total score of > 12 on the Kessler Psychological Distress Scale (K10; 0 to 40 range)
- •18 years of age or older
- •Can read and comprehend English
排除标准
- •Do not pass the informed decision-making capacity screener, suggesting cognitive impairment or an inability to provide informed consent
- •Presence of a psychiatric or medical condition that would prevent them from providing informed consent or participating in the treatments (e.g., psychosis, mania, acute intoxication)
- •Current comorbid moderate to severe substance use disorder other than alcohol and opioids
- •Limited or no access to a smart phone that is compatible with the mobile application
- •Participation in Phase One
- •Possibility of being pregnant (by self-report)
- •Current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer
研究组 & 干预措施
Managing Physical Reactions to Overwhelming Emotions (IMPROVE)
In this arm, participants will receive the IMPROVE intervention, a clinician-delivered protocol targeting anxiety and uncertainty.
干预措施: Managing Physical Reactions to Overwhelming Emotions (IMPROVE) (Behavioral)
Health Education Training (HET)
In this arm, participants will receive a clinician-delivered protocol with a digital component, called HET. HET focuses on healthy living more broadly and does not include information about anxiety or uncertainty.
干预措施: Health Education Training (HET) (Behavioral)
结局指标
主要结局
Alcohol Use
时间窗: Change 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 threat
时间窗: Change 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 Uncertainty
时间窗: Change 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 images
时间窗: Change 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 Sensitivity
时间窗: Change 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.
次要结局
- Medication Adherence(Change from baseline to post-treatment (week 4))
- Distress-related alcohol use(Assessed multiple times a day for 21 days)
- Daily alcohol craving(Assessed multiple times a day for 21 days)
研究者
Stephanie M Gorka, PhD
Associate Professor
Ohio State University