Trial Outcomes & Findings for Stress, Emotion Regulation, and Alcohol in Women Veterans (NCT NCT04393623)
NCT ID: NCT04393623
Last Updated: 2026-02-27
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
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.
Results posted on
2026-02-27
Participant Flow
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.
Participants completed an initial phone screen to determine general eligibility; if eligible, they were scheduled for session 1 (n=81). At session 1, participants consented to the study and then were further screened via clinical interview for remaining inclusion/exclusion criteria. One participant was not eligible after the clinical interview, leaving n=80. 3 participants were lost to contact between the first session and the intervention session, and therefore not randomized, leaving n=77.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
39
|
|
Overall Study
Session 2 (Intervention)
|
34
|
36
|
|
Overall Study
Session 3 (Experimental)
|
32
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
Baseline Characteristics
Stress, Emotion Regulation, and Alcohol in Women Veterans
Baseline characteristics by cohort
| Measure |
Cognitive Reappraisal Microintervention
n=38 Participants
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.
|
Psychoeducation (Control)
n=39 Participants
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.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 Years
STANDARD_DEVIATION 10 • n=24 Participants
|
41 Years
STANDARD_DEVIATION 14 • n=20 Participants
|
41 Years
STANDARD_DEVIATION 12 • n=40 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=24 Participants
|
39 Participants
n=20 Participants
|
77 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=24 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=24 Participants
|
36 Participants
n=20 Participants
|
70 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=24 Participants
|
38 Participants
n=20 Participants
|
72 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Veteran Status
Veterans
|
31 Participants
n=24 Participants
|
30 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
|
Veteran Status
Non-Veterans
|
7 Participants
n=24 Participants
|
9 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 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.Population: Data reflects participants in the Control Condition who completed at least one experimental session and including in Alcohol Craving Analyses
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).
Outcome measures
| Measure |
Cognitive Reappraisal Microintervention
n=32 Participants
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.
|
Psychoeducation (Control)
n=34 Participants
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.
|
|---|---|---|
|
Change in Alcohol Craving During Experimental Sessions
ACQ Score - Post-Stress Induction (Range: 1-7)
|
3.18 Units on a Scale
Standard Deviation 1.11
|
3.22 Units on a Scale
Standard Deviation 0.86
|
|
Change in Alcohol Craving During Experimental Sessions
ACQ score - Baseline (Range: 1-7)
|
2.87 Units on a Scale
Standard Deviation 0.78
|
2.97 Units on a Scale
Standard Deviation 0.69
|
|
Change in Alcohol Craving During Experimental Sessions
ACQ Score - Post Cognitive Reappraisal/Sitting Quietly (Range: 1-7)
|
3.27 Units on a Scale
Standard Deviation 1.01
|
3.24 Units on a Scale
Standard Deviation 1.02
|
PRIMARY outcome
Timeframe: 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).Population: Data reflects participants in the Control Condition who completed at least one experimental session and including in Alcohol Craving Analyses
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.
Outcome measures
| Measure |
Cognitive Reappraisal Microintervention
n=32 Participants
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.
|
Psychoeducation (Control)
n=34 Participants
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.
|
|---|---|---|
|
Change in Heart Rate Variability (HRV) During Experimental Sessions
RMSSD - Baseline
|
47.20 milliseconds (ms)
Standard Deviation 48.96
|
36.64 milliseconds (ms)
Standard Deviation 22.48
|
|
Change in Heart Rate Variability (HRV) During Experimental Sessions
RMSSD - Post-Stress Induction
|
108.33 milliseconds (ms)
Standard Deviation 246.57
|
34.82 milliseconds (ms)
Standard Deviation 23.23
|
|
Change in Heart Rate Variability (HRV) During Experimental Sessions
RMSSD - Post Cognitive Reappraisal/Sitting Quietly
|
62.69 milliseconds (ms)
Standard Deviation 91.60
|
40.68 milliseconds (ms)
Standard Deviation 30.30
|
PRIMARY outcome
Timeframe: Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 daysPopulation: Data reflects participants in the Control Condition who completed at least one experimental session and including in Alcohol Craving Analyses
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
Outcome measures
| Measure |
Cognitive Reappraisal Microintervention
n=32 Participants
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.
|
Psychoeducation (Control)
n=34 Participants
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.
|
|---|---|---|
|
Change in Frequency of Alcohol Use Prior to and Through Study Completion
Percent Days Drinking (PDD) - Baseline (45 days prior to study enrollment)
|
46.49 Percent Days Drinking (PDD)
Standard Deviation 29.82
|
45.91 Percent Days Drinking (PDD)
Standard Deviation 27.74
|
|
Change in Frequency of Alcohol Use Prior to and Through Study Completion
Percent Days Drinking (PDD) - Post (From Baseline through Study Completion)
|
54.57 Percent Days Drinking (PDD)
Standard Deviation 30.24
|
47.15 Percent Days Drinking (PDD)
Standard Deviation 28.14
|
PRIMARY outcome
Timeframe: Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 daysPopulation: Data reflects participants in the Control Condition who completed at least one experimental session and including in Alcohol Craving Analyses
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
Outcome measures
| Measure |
Cognitive Reappraisal Microintervention
n=32 Participants
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.
|
Psychoeducation (Control)
n=34 Participants
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.
|
|---|---|---|
|
Change in Intensity of Alcohol Use Prior to and Through Study Completion
MDPDD - Baseline (45 days prior to study enrollment)
|
2.98 Mean Drinks per Drinking Day (MDPDD)
Standard Deviation 1.74
|
2.42 Mean Drinks per Drinking Day (MDPDD)
Standard Deviation 1.12
|
|
Change in Intensity of Alcohol Use Prior to and Through Study Completion
MDPDD - Post (From Baseline through Study Completion)
|
2.63 Mean Drinks per Drinking Day (MDPDD)
Standard Deviation 1.18
|
2.37 Mean Drinks per Drinking Day (MDPDD)
Standard Deviation 1.12
|
Adverse Events
Cognitive Reappraisal Microintervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Psychoeducation (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cathryn Glanton Holzhauer, PhD
University of Connecticut School of Medicine
Phone: (860) 679-4154
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place