Understanding and Targeting Stress Reactivity in Women Veterans With Alcohol Misuse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change in Alcohol Craving During Experimental Sessions
研究概览
简要总结
The purpose of the study "Stress, Emotion Regulation, and Alcohol in Women Veterans" is to learn about the effects of negative emotion and stress on behavior (including alcohol use) among women Veterans, including women with and without posttraumatic stress disorder. Additionally, the study looks at whether a woman's use of emotion regulation techniques changes the association between stress or negative emotion and behavior. Lastly, the study examines how women's reactions to stress, and the effects of stress, vary across the menstrual cycle - depending on the level of circulating hormones.
详细描述
Aims for the current study are two-fold: 1. conduct a randomized trial testing the effects of an emotion regulation skill (cognitive reappraisal) on stress-induced drinking among women with alcohol misuse and varying levels of co-occurring PTSD; 2. examine whether progesterone levels and/or severity of co-occurring PTSD - factors which impact women's stress reactivity and emotion regulation - moderate the effectiveness of the cognitive reappraisal in reducing stress-induced drinking.
The proposed study will combine experimental, in-person sessions with daily self-report data from the Veterans to assess the effect of cognitive reappraisal on alcohol craving, cognitive (inhibitory) control, physiological arousal (HRV), and alcohol use. Participation will take place across a period of at least 35 days, to encompass an entire menstrual cycle. All participants complete all sections of the study - the experimental sessions and the longitudinal (35-day) data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Current alcohol misuse, defined as scoring 3 or higher on the AUDIT-C
- •If using other illicit substances, alcohol is their primary substance of use
- •Alcohol use in the past 45 days
- •Able to write and speak in English
- •Served in the U.S. Military
- •Willing to provide blood samples at laboratory sessions to assay hormone levels and take urine ovulation tests at home
排除标准
- •Psychotic symptoms or uncontrolled Bipolar Disorder (screened for during session 1 using SCID-5 screening modules)
- •Brain damage or were in an accident that affects ability to complete the computerized task
- •Current (past 3 months) active suicidal ideation or intent
- •Current pregnancy
研究组 & 干预措施
Cognitive Reappraisal Microintervention
The CR microintervention (session 1) is drawn from Barlow & colleagues empirically supported treatment for emotional disorders (the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders). The microintervention consist of four sections: (1) Introduction to cognitive appraisal; (2) Introducing the idea of "thinking traps" that prevent reappraisal and maintain negative emotion; (3) Describing cognitive reappraisal as a strategy that can help the participant "get out" of such thinking traps; (4) Providing an example of this process (situation> negative appraisal > negative emotion > thinking trap > opportunity for cognitive reappraisal) and have participants provide a personalized example.
干预措施: Cognitive Reappraisal (Behavioral)
Psychoeducation (Control)
The manualized psychoeducational control module, serving as an attentional control, is derived from two sources: 1. The first session of the Women's Health Education Manual, which provides psychoeducation about the basic body systems and their function, with focus on components of the immune system and 2. Fact sheets published by the American College of Obstetricians and Gynecologists(ACOG), providing female-specific facts about cancer and heart health. None of this psychoeducation discusses potential relevancy of alcohol use, nor will any behavior changes be suggested during the control microintervention.
干预措施: Psychoeducation (Behavioral)
结局指标
主要结局
Change in Alcohol Craving During Experimental Sessions
时间窗: Outcomes are measured 3 times during the experimental session to examine change: At the start of the session (Baseline), after a 6-minute stress induction, and after using cognitive reappraisal (or sitting quietly, if in the control) for 6 minutes.
Craving will be measured via the Alcohol Craving Questionnaire - Short Form (ACQ-SF). The ACQ-SF comprises 12 items and is used to assess alcohol cravings among alcohol users in the current moment. Participants are asked to rate how much they agree or disagree with each statement, each regarding how they feel or think about alcohol in the moment. Each item is scored on a 7-point Likert scale that reflects their agreement on a scale of "strongly disagree" to "strongly agree". Total score is an average of responses to each of the 12 items with a range of scores from 1.00-7.00; A higher total score reflects higher craving for alcohol (worse clinical outcome), and a lower score reflects lower craving for alcohol (better clinical outcome).
Change in Heart Rate Variability (HRV) During Experimental Sessions
时间窗: Outcomes are measured 3 times during the experimental session to examine change: At start of the session (5 minute baseline), during a 6-minute stress induction, and for 5 minutes after using cognitive reappraisal (or sitting quietly, if in the control).
Heart rate variability (HRV), a physiological measure of arousal and shown to be a measure of stress reactivity and impacted by successful emotion regulation, will be assessed with a Biopac MP160 data acquisition unit with an ECG amplifier that allows for the measurement of HRV.
Change in Frequency of Alcohol Use Prior to and Through Study Completion
时间窗: Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 days
The Alcohol Timeline Follow Back (TLFB) assesses frequency/quantity of drinking. The TLFB will be used at all laboratory sessions to fill in any potentially missing data from the daily logs
Change in Intensity of Alcohol Use Prior to and Through Study Completion
时间窗: Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 days
The Alcohol Timeline Follow Back (TLFB) assesses frequency/quantity of drinking. The TLFB will be used at all laboratory sessions to fill in any potentially missing data from the daily logs
次要结局
未报告次要终点