An interventional study of Cognitive Reappraisal and Psychoeducation in Alcohol Use Disorder and Post Traumatic Stress Disorder, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Other
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.
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 81 is close to the median of 87 across 1,371 interventional studies indexed under Alcoholism.
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Exclusion Criteria:
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
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 cognitive reappraisal microintervention lasts 45-60 minutes.
This psychoeducational microintervention lasts 45-60 minutes.
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).
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.
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.
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).
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
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
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
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
Participants were women recruited from two sources: 1. Department of Veteran Affairs Medical Center and 2. recruited from the general population/surrounding community. All participants were recruited in the Northeast region of the US.
| Milestone | Cognitive Reappraisal Microintervention | Psychoeducation (Control) |
|---|---|---|
| Started | 38 | 39 |
| Session 2 (intervention) | 34 | 36 |
| Session 3 (experimental) | 32 | 34 |
| Completed | 34 | 34 |
| Not completed | 4 | 5 |
| Withdrew: Lost to follow-up | 4 | 5 |
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).
| Units on a Scale | Cognitive Reappraisal Microintervention | Psychoeducation (Control) |
|---|---|---|
| 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 |
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.
| milliseconds (ms) | Cognitive Reappraisal Microintervention | Psychoeducation (Control) |
|---|---|---|
| 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 |
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
| Percent Days Drinking (PDD) | Cognitive Reappraisal Microintervention | Psychoeducation (Control) |
|---|---|---|
| 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 |
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
| Mean Drinks per Drinking Day (MDPDD) | Cognitive Reappraisal Microintervention | Psychoeducation (Control) |
|---|---|---|
| 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 |
Collected over From enrollment to the end of study participation, up to 75 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive Reappraisal Microintervention | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Psychoeducation (Control) | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Age, Continuous(Years) | Cognitive Reappraisal Microintervention | Psychoeducation (Control) | Total |
|---|---|---|---|
| Mean | 41 ± 10 | 41 ± 14 | 41 ± 12 |
| Sex: Female, Male(Participants) | Cognitive Reappraisal Microintervention | Psychoeducation (Control) | Total |
|---|---|---|---|
| Female | 38 | 39 | 77 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cognitive Reappraisal Microintervention | Psychoeducation (Control) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 34 | 36 | 70 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Cognitive Reappraisal Microintervention | Psychoeducation (Control) | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 1 | 5 |
| Not Hispanic or Latino | 34 | 38 | 72 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Veteran Status(Participants) | Cognitive Reappraisal Microintervention | Psychoeducation (Control) | Total |
|---|---|---|---|
| Veterans | 31 | 30 | 61 |
| Non-Veterans | 7 | 9 | 16 |
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