Alcohol Use DisorderSERANCT04393623

Stress, Emotion Regulation, and Alcohol in Women Veterans

A study testing Cognitive Reappraisal and Psychoeducation in people with Alcohol Use Disorder and Post Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Alcohol Use Disorder, Post Traumatic Stress Disorder
What is being tested?: Cognitive Reappraisal and Psychoeducation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2020to 30 Sep 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, 01053-9764

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: Cognitive Reappraisal, Psychoeducation
Keywords: Alcohol Use Disorder, Women Veterans, Endocrinology, Cognitive Reappraisal, Microintervention, Progesterone, Posttraumatic Stress Disorder, Psychophysiology, Heart Rate Variability
Medical subject headings: Alcoholism, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive ReappraisalBehavioural
This cognitive reappraisal microintervention lasts 45-60 minutes.
PsychoeducationBehavioural
This psychoeducational microintervention lasts 45-60 minutes.

Study groups in NCT04393623
Study group	Role	What they receive
Cognitive Reappraisal Microintervention	Experimental	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. Receives: Behavioral: Cognitive Reappraisal
Psychoeducation (Control)	Active comparator	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. Receives: Behavioral: Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

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". Total score is an average of responses to each of the 12 items with a range of scores from 1.00-7.00; A higher total score reflects higher craving for alcohol (worse clinical outcome), and a lower score reflects lower craving for alcohol (better clinical outcome).
Measured: 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.
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.
Measured: Outcomes are measured 3 times during the experimental session to examine change: At start of the session (5 minute baseline), during a 6-minute stress induction, and for 5 minutes after using cognitive reappraisal (or sitting quietly, if in the control).
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
Measured: Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 days
Change in Intensity 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
Measured: Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202030 Sep 2024

First posted19 May 2020
Study start1 Nov 2020
Primary completion30 Sep 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be urn randomized to either an experimental (cognitive reappraisal) or control condition.
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04393623
Sponsor's protocol ID: MHBB-017-18F
Other IDs: DVA/CSR&D CDA-2 CX001951
Acronym: SERA
Status last verified: Feb 2026
First submitted: 27 Apr 2020
Last updated: 27 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Understanding and Targeting Stress Reactivity in Women Veterans With Alcohol Misuse
ClinicalTrials.gov ID: NCT04393623
Acronym / sponsor ID: SERA / MHBB-017-18F
Conditions: Alcohol Use Disorder, Post Traumatic Stress Disorder
Keywords: Alcohol Use Disorder, Women Veterans, Endocrinology, Cognitive Reappraisal, Microintervention, Progesterone, Posttraumatic Stress Disorder, Psychophysiology
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Nov 2020 (actual)
Primary completion: 30 Sep 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 19 May 2020 (actual)
Results: Posted 27 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be urn randomized to either an experimental (cognitive reappraisal) or control condition.

Arm	Type	Receives
Cognitive Reappraisal Microintervention	Experimental	Behavioral: Cognitive ReappraisalThe 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.
Psychoeducation (Control)	Active comparator	Behavioral: PsychoeducationThe 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive ReappraisalThis cognitive reappraisal microintervention lasts 45-60 minutes.	Behavioural	Cognitive Reappraisal Microintervention
PsychoeducationThis psychoeducational microintervention lasts 45-60 minutes.	Behavioural	Psychoeducation (Control)

Primary outcome

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.
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". Total score is an average of responses to each of the 12 items with a range of scores from 1.00-7.00; A higher total score reflects higher craving for alcohol (worse clinical outcome), and a lower score reflects lower craving for alcohol (better clinical outcome).
Change in Heart Rate Variability (HRV) During Experimental Sessions
Time frame: Outcomes are measured 3 times during the experimental session to examine change: At start of the session (5 minute baseline), during a 6-minute stress induction, and for 5 minutes after using cognitive reappraisal (or sitting quietly, if in the control).
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
Time frame: Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 days
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
Change in Intensity of Alcohol Use Prior to and Through Study Completion
Time frame: Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 days
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

Results and safety

Results posted to the registry on 27 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitive Reappraisal Microintervention	38	34
Psychoeducation (Control)	39	34

Primary outcome: 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.. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Cognitive Reappraisal Microintervention n = 32	Psychoeducation (Control) n = 34
ACQ score - Baseline (Range: 1-7)	2.87 (0.78)	2.97 (0.69)
ACQ Score - Post-Stress Induction (Range: 1-7)	3.18 (1.11)	3.22 (0.86)
ACQ Score - Post Cognitive Reappraisal/Sitting Quietly (Range: 1-7)	3.27 (1.01)	3.24 (1.02)

Cognitive Reappraisal Microintervention vs Psychoeducation (Control): Wilks' Lambda: .998, p = .94, Mixed Models Analysis

Population analysed: Data reflects participants in the Control Condition who completed at least one experimental session and including in Alcohol Craving Analyses

Primary outcome: Change in Heart Rate Variability (HRV) During Experimental Sessions

Time frame: Outcomes are measured 3 times during the experimental session to examine change: At start of the session (5 minute baseline), during a 6-minute stress induction, and for 5 minutes after using cognitive reappraisal (or sitting quietly, if in the control).. Mean (Standard Deviation). Unit: milliseconds (ms)

Measure	Cognitive Reappraisal Microintervention n = 32	Psychoeducation (Control) n = 34
RMSSD - Baseline	47.20 (48.96)	36.64 (22.48)
RMSSD - Post-Stress Induction	108.33 (246.57)	34.82 (23.23)
RMSSD - Post Cognitive Reappraisal/Sitting Quietly	62.69 (91.60)	40.68 (30.30)

Cognitive Reappraisal Microintervention vs Psychoeducation (Control): Wilks' Lambda: .912, Mixed Models Analysis

Population analysed: Data reflects participants in the Control Condition who completed at least one experimental session and including in Alcohol Craving Analyses

Primary outcome: Change in Frequency of Alcohol Use Prior to and Through Study Completion

Time frame: Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 days. Mean (Standard Deviation). Unit: Percent Days Drinking (PDD)

Measure	Cognitive Reappraisal Microintervention n = 32	Psychoeducation (Control) n = 34
Percent Days Drinking (PDD) - Baseline (45 days prior to study enrollment)	46.49 (29.82)	45.91 (27.74)
Percent Days Drinking (PDD) - Post (From Baseline through Study Completion)	54.57 (30.24)	47.15 (28.14)

Cognitive Reappraisal Microintervention vs Psychoeducation (Control): Wilks' Lambda: .996, Mixed Models Analysis

Population analysed: Data reflects participants in the Control Condition who completed at least one experimental session and including in Alcohol Craving Analyses

Primary outcome: Change in Intensity of Alcohol Use Prior to and Through Study Completion

Measure	Cognitive Reappraisal Microintervention n = 32	Psychoeducation (Control) n = 34
MDPDD - Baseline (45 days prior to study enrollment)	2.98 (1.74)	2.42 (1.12)
MDPDD - Post (From Baseline through Study Completion)	2.63 (1.18)	2.37 (1.12)

Cognitive Reappraisal Microintervention vs Psychoeducation (Control): Wilks' Lambda: 0.978, Mixed Models Analysis

Population analysed: Data reflects participants in the Control Condition who completed at least one experimental session and including in Alcohol Craving Analyses

Adverse events

Time frame: From enrollment to the end of study participation, up to 75 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cognitive Reappraisal Microintervention	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Psychoeducation (Control)	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Limitations and caveats (from the sponsor): The results reported here reflect the main effects of the intervention condition (Cognitive Reappraisal versus Control condition) on outcome measures assessed in the laboratory and in daily life during study participation. Secondary analyses of study data indicate that severity of Alcohol Use Disorder may impact condition effects, and therefore will be examined in future analyses. Broadening of study inclusion and exclusion criteria during the study has elicited additional analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cathryn Glanton Holzhauer, PhD principal investigator

VA Central Western Massachusetts Healthcare System, Leeds, MA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04393623.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.