Stress, Emotion Regulation, and Alcohol in Women Veterans (SERA)

VA Office of Research and Development

Status: Completed

Conditions: Post Traumatic Stress Disorder; Alcohol Use Disorder

Treatments: Behavioral: Psychoeducation; Behavioral: Cognitive Reappraisal

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04393623

MHBB-017-18F

DVA/CSR&D CDA-2 CX001951 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Cognitive Reappraisal Microintervention

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Reappraisal

Psychoeducation (Control)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychoeducation