Clinical trial NCT04393623: Stress, Emotion Regulation, and Alcohol in Women Veterans
Official title: Understanding and Targeting Stress Reactivity in Women Veterans With Alcohol Misuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Post Traumatic Stress Disorder
Keywords: Alcohol Use Disorder
Women Veterans
Endocrinology
Cognitive Reappraisal
Microintervention
Progesterone
Posttraumatic Stress Disorder
Psychophysiology
Heart Rate Variability
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-05-19
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be urn randomized to either an experimental (cognitive reappraisal) or control condition.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Alcohol Craving during Experimental Sessions
timeFrame: Two separate days during the study (ie. on two of the study days, which last up to 75 days)
measure: Change in Inhibitory Control during Experimental Sessions
timeFrame: Two separate days during the study (ie. on two of the study days, which last up to 75 days)
measure: Change in Heart Rate Variability (HRV) during Experimental Sessions
timeFrame: Two separate days during the study (ie. on two of the study days, which last up to 75 days)
measure: Change in frequency of alcohol use prior to and through study completion
timeFrame: Retrospectively for 45 days prior to study enrollment, and through study completion (up to 75 days post-baseline)
Secondary outcomes:
measure: Change in intensity of daily negative affect
timeFrame: Daily, through study completion (up to 75 days post-baseline)
measure: Change in depression symptoms from baseline to study completion, un to 75 days
timeFrame: Baseline, end of study (up to 75 days)
measure: Change in depression symptoms from baseline to study completion, un to 75 days
timeFrame: Baseline, end of study (up to 75 days)
measure: Change in use of adaptive and maladaptive emotion regulation strategies
timeFrame: weekly, through study completion (up to 75 days post-baseline)
Other outcomes:
Locations:
city: Leeds
country: United States
facility: VA Central Western Massachusetts Healthcare System, Leeds, MA
state: Massachusetts
Study officials:
affiliation: VA Central Western Massachusetts Healthcare System, Leeds, MA
name: Cathryn Glanton Holzhauer, PhD
role: PRINCIPAL_INVESTIGATOR
References: