Stress, Emotion Regulation, and Alcohol in Women Veterans

Alcohol Use Disorder Clinical Trial

— SERA  

Official title:

Understanding and Targeting Stress Reactivity in Women Veterans With Alcohol Misuse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04393623
• Other study ID #: MHBB-017-18F
• Secondary ID: DVA/CSR&D CDA-2
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Cathryn G Holzhauer, PhD
• Phone: (413) 584-4040
• Email: cathryn.holzhauer[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Cognitive Reappraisal
This cognitive reappraisal microintervention lasts 45-60 minutes.
• Psychoeducation
This psychoeducational microintervention lasts 45-60 minutes.

Locations

Country	Name	City	State
United States	VA Central Western Massachusetts Healthcare System, Leeds, MA	Leeds	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alcohol Craving during Experimental Sessions	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".	Two separate days during the study (ie. on two of the study days, which last up to 75 days)
Primary	Change in Inhibitory Control during Experimental Sessions	Inhibitory Control, a measure of behavioral impulsivity, will be assessed with a computerized task (a stop-signal task, STOP-IT). Participants' stop signal reaction time (SSRT) reflects varying levels of inhibitory control (lower SSRT reflects better inhibitory control).	Two separate days during the study (ie. on two of the study days, which last up to 75 days)
Primary	Change in Heart Rate Variability (HRV) during Experimental Sessions	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.	Two separate days during the study (ie. on two of the study days, which last up to 75 days)
Primary	Change in frequency of alcohol use prior to and through study completion	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	Retrospectively for 45 days prior to study enrollment, and through study completion (up to 75 days post-baseline)
Secondary	Change in intensity of daily negative affect	The Positive and Negative Affect Schedule (PANAS) is a 10 item questionnaire that measures self reported positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Scores range from 10-50.	Daily, through study completion (up to 75 days post-baseline)
Secondary	Change in depression symptoms from baseline to study completion, un to 75 days	Beck Depression Inventory II (BDI-II) is a self-report questionnaire assessing depression symptoms over the prior two weeks (scores range 0-63) and higher scores indicate greater depression symptomatology. All item scores are summed to attain a total score.	Baseline, end of study (up to 75 days)
Secondary	Change in depression symptoms from baseline to study completion, un to 75 days	PTSD Checklist for DSM-5 with Life Events checklist and Criterion A (PCL-5) is a 20-item self-report questionnaires assessing current symptoms of PTSD, used to assess current (past 30 days) PTSD severity. Total scores are calculated by summing all values. Scores on the PCL-5 range from 0-80 and reflect a global PTSD severity score, with higher scores indicating greater severity.	Baseline, end of study (up to 75 days)
Secondary	Change in use of adaptive and maladaptive emotion regulation strategies	Emotion Regulation Questionnaire (ERQ) is 10-item questionnaire measuring emotion regulation. Items are rated on a 7-point Likert-scale ranging from 1 (strongly disagree) to 7 (strongly agree). Specifically, the measure assesses use of the strategies cognitive reappraisal and emotional suppression, which are separate subscales. Higher scores reflect greater use of each type of emotion regulation strategy.	weekly, through study completion (up to 75 days post-baseline)