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

Primary Purpose

Alcohol Use Disorder, Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Reappraisal
Psychoeducation
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder focused on measuring Alcohol Use Disorder, Women Veterans, Endocrinology, Cognitive Reappraisal, Microintervention, Progesterone, Posttraumatic Stress Disorder, Psychophysiology, Heart Rate Variability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • VA Central Western Massachusetts Healthcare System, Leeds, MARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Reappraisal Microintervention

Psychoeducation (Control)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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".
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).
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.
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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 27, 2020
Last Updated
August 24, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04393623
Brief Title
Stress, Emotion Regulation, and Alcohol in Women Veterans
Acronym
SERA
Official Title
Understanding and Targeting Stress Reactivity in Women Veterans With Alcohol Misuse
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be urn randomized to either an experimental (cognitive reappraisal) or control condition.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Reappraisal Microintervention
Arm Type
Experimental
Arm 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.
Arm Title
Psychoeducation (Control)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Reappraisal
Intervention Description
This cognitive reappraisal microintervention lasts 45-60 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
This psychoeducational microintervention lasts 45-60 minutes.
Primary Outcome Measure Information:
Title
Change in Alcohol Craving during Experimental Sessions
Description
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".
Time Frame
Two separate days during the study (ie. on two of the study days, which last up to 75 days)
Title
Change in Inhibitory Control during Experimental Sessions
Description
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).
Time Frame
Two separate days during the study (ie. on two of the study days, which last up to 75 days)
Title
Change in Heart Rate Variability (HRV) during Experimental Sessions
Description
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.
Time Frame
Two separate days during the study (ie. on two of the study days, which last up to 75 days)
Title
Change in frequency of alcohol use prior to and through study completion
Description
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
Time Frame
Retrospectively for 45 days prior to study enrollment, and through study completion (up to 75 days post-baseline)
Secondary Outcome Measure Information:
Title
Change in intensity of daily negative affect
Description
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.
Time Frame
Daily, through study completion (up to 75 days post-baseline)
Title
Change in depression symptoms from baseline to study completion, un to 75 days
Description
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.
Time Frame
Baseline, end of study (up to 75 days)
Title
Change in depression symptoms from baseline to study completion, un to 75 days
Description
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.
Time Frame
Baseline, end of study (up to 75 days)
Title
Change in use of adaptive and maladaptive emotion regulation strategies
Description
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.
Time Frame
weekly, through study completion (up to 75 days post-baseline)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathryn G Holzhauer, PhD
Phone
(413) 584-4040
Email
cathryn.holzhauer@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Amber N Brown
Phone
(413) 584-4040
Ext
6528
Email
Amber.Brown8@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathryn Glanton Holzhauer, PhD
Organizational Affiliation
VA Central Western Massachusetts Healthcare System, Leeds, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Central Western Massachusetts Healthcare System, Leeds, MA
City
Leeds
State/Province
Massachusetts
ZIP/Postal Code
01053-9764
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber N Brown
Phone
(413) 584-4040
Ext
6528
Email
Amber.Brown8@va.gov
First Name & Middle Initial & Last Name & Degree
Cathryn G Holzhauer, PhD
Phone
(413) 584-4040
Email
cathryn.holzhauer@va.gov
First Name & Middle Initial & Last Name & Degree
Cathryn Glanton Holzhauer, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Stress, Emotion Regulation, and Alcohol in Women Veterans

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