Stress, Emotion Regulation, and Alcohol in Women Veterans

Part of paid clinical trials in Leeds, Massachusetts.

Sponsor
VA Office of Research and Development
Study ID
NCT04393623
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Reappraisal — BEHAVIORAL
    This cognitive reappraisal microintervention lasts 45-60 minutes.
  • Psychoeducation — BEHAVIORAL
    This psychoeducational microintervention lasts 45-60 minutes.

Study Details

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.

Key Dates

Start date
Nov 1, 2020
Status verified
Feb 2026
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
81 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Alcohol Craving During Experimental Sessions [ Time Frame: 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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
VA Central Western Massachusetts Healthcare System, Leeds, MALeedsMassachusetts01053-9764-

Find similar trials in Leeds, MA

By condition
Substance use disorderPTSD (post-traumatic stress disorder)
By specialty
Behavioral healthAddiction medicinePsychiatryMental health
By research site
VA Central Western Massachusetts Healthcare System, Leeds, MA· Leeds, MA

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