Stress, Emotion Regulation, and Alcohol in Women Veterans

NCT04393623 | Completed Results

• 2 other identifiers: MHBB-017-18FDVA/CSR&D CDA-2 CX001951
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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". 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).

  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.

• 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.

  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).

• 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

  Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 days

• Change in Intensity 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

  Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 days

Study Arms (2)

Cognitive Reappraisal Microintervention

EXPERIMENTAL

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.

Behavioral: Cognitive Reappraisal

Psychoeducation (Control)

ACTIVE COMPARATOR

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.

Behavioral: Psychoeducation

Interventions

Cognitive Reappraisal BEHAVIORAL

This cognitive reappraisal microintervention lasts 45-60 minutes.

Cognitive Reappraisal Microintervention

Psychoeducation BEHAVIORAL

This psychoeducational microintervention lasts 45-60 minutes.

Psychoeducation (Control)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, 01053-9764, United States

Location

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Limitations and Caveats

The results reported here reflect the main effects of the intervention condition (Cognitive Reappraisal versus Control condition) on outcome measures assessed in the laboratory and in daily life during study participation. Secondary analyses of study data indicate that severity of Alcohol Use Disorder may impact condition effects, and therefore will be examined in future analyses. Broadening of study inclusion and exclusion criteria during the study has elicited additional analyses.

Results Point of Contact

• Title: Cathryn Glanton Holzhauer, PhD
• Organization: University of Connecticut School of Medicine

caholzhauer@uchc.edu

(860) 679-4154

Study Officials

• Cathryn Glanton Holzhauer, PhD

  VA Central Western Massachusetts Healthcare System, Leeds, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be urn randomized to either an experimental (cognitive reappraisal) or control condition.

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 19, 2020
• Study Start: November 1, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)