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

Understanding and Targeting Stress Reactivity in Women Veterans With Alcohol Misuse

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.

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Stress Disorder; Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Cognitive Reappraisal; Behavioral: Psychoeducation

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cathryn G Holzhauer, PhD; Phone Number: (413) 584-4040; Email: cathryn.holzhauer@va.gov
• Study Contact Backup: Name: Amber N Brown; Phone Number: 6528 (413) 584-4040; Email: Amber.Brown8@va.gov

Study Locations

• United States
  • Massachusetts
    • Leeds, Massachusetts, United States, 01053-9764
      • Recruiting
      • VA Central Western Massachusetts Healthcare System, Leeds, MA
      • Contact: Cathryn G Holzhauer, PhD; Phone Number: (413) 584-4040; Email: cathryn.holzhauer@va.gov
      • Contact: Amber N Brown; Phone Number: 6528 (413) 584-4040; Email: Amber.Brown8@va.gov
      • Principal Investigator: Cathryn Glanton Holzhauer, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Cognitive Reappraisal; This cognitive reappraisal microintervention lasts 45-60 minutes.
Active Comparator: 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.	Behavioral: Psychoeducation; This psychoeducational microintervention lasts 45-60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Cathryn Glanton Holzhauer, PhD, VA Central Western Massachusetts Healthcare System, Leeds, MA

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Heart Rate Variability; Endocrinology; Posttraumatic Stress Disorder; Alcohol Use Disorder; Progesterone; Cognitive Reappraisal; Psychophysiology; Women Veterans; Microintervention
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Trauma and Stressor Related Disorders; Alcohol Drinking; Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: MHBB-017-18F; DVA/CSR&D CDA-2 CX001951 (Other Grant/Funding Number: Veterans Health Administration, Office of Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No