Stress, Emotion Regulation, and Alcohol in Women Veterans

NCT ID: NCT04393623

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2024-09-30

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.

Conditions

Alcohol Use Disorder; Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Reappraisal

Intervention Type: BEHAVIORAL

This cognitive reappraisal microintervention lasts 45-60 minutes.

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.

Group Type: ACTIVE_COMPARATOR

Psychoeducation

Intervention Type: BEHAVIORAL

This psychoeducational microintervention lasts 45-60 minutes.

Interventions

Cognitive Reappraisal

This cognitive reappraisal microintervention lasts 45-60 minutes.

Intervention Type: BEHAVIORAL

Psychoeducation

This psychoeducational microintervention lasts 45-60 minutes.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cathryn Glanton Holzhauer, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Central Western Massachusetts Healthcare System, Leeds, MA

Locations

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

DVA/CSR&D CDA-2 CX001951

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MHBB-017-18F

Identifier Type: -

Identifier Source: org_study_id