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| ID | Type | Description | Link |
|---|---|---|---|
| DVA/CSR&D CDA-2 CX001951 | Other Grant/Funding Number | Veterans Health Administration, Office of Research |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Reappraisal | Behavioral | This cognitive reappraisal microintervention lasts 45-60 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cathryn Glanton Holzhauer, PhD | VA Central Western Massachusetts Healthcare System, Leeds, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Central Western Massachusetts Healthcare System, Leeds, MA | Leeds | Massachusetts | 01053-9764 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants were women 18 years or older |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Data reflects participants in the Control Condition who completed at least one experimental session and including in Alcohol Craving Analyses | Posted | Mean | Standard Deviation | Units on a Scale | 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. |
From enrollment to the end of study participation, up to 75 days.
There are no differences in definition of adverse events or any other relevant information about the way this study collected information about adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cathryn Glanton Holzhauer, PhD | University of Connecticut School of Medicine | (860) 679-4154 | caholzhauer@uchc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2022 | Dec 11, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2024 | Nov 5, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Participants will be urn randomized to either an experimental (cognitive reappraisal) or control condition.
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| Psychoeducation | Behavioral | This psychoeducational microintervention lasts 45-60 minutes. |
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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 |
| Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 days |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
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| Sex: Female, Male | This study only included people who identify as women | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Whether participants consider themselves latino/hispanic or not. | Count of Participants | Participants |
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| Veteran Status | Number of participants in each group who were Veterans or non-Veterans | Count of Participants | Participants | No |
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| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
| OG001 | 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. |
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| Primary | 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. | Data reflects participants in the Control Condition who completed at least one experimental session and including in Alcohol Craving Analyses | Posted | Mean | Standard Deviation | milliseconds (ms) | 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). |
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| Primary | 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 | Data reflects participants in the Control Condition who completed at least one experimental session and including in Alcohol Craving Analyses | Posted | Mean | Standard Deviation | Percent Days Drinking (PDD) | Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 days |
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| Primary | 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 | Data reflects participants in the Control Condition who completed at least one experimental session and including in Alcohol Craving Analyses | Posted | Mean | Standard Deviation | Mean Drinks per Drinking Day (MDPDD) | Baseline was measured retrospectively for 45 days prior to study enrollment. Post was measured from baseline through study completion, up to 75 days |
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| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | 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. | 0 | 39 | 0 | 39 | 0 | 39 |
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| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| RMSSD - Post Cognitive Reappraisal/Sitting Quietly |
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