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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
81
This cognitive reappraisal microintervention lasts 45-60 minutes.
This psychoeducational microintervention lasts 45-60 minutes.
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, United States
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".
Time frame: Two separate days during the study (ie. on two of the study days, which last up to 75 days)
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).
Time frame: Two separate days during the study (ie. on two of the study days, which last up to 75 days)
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: Two separate days during the study (ie. on two of the study days, which last up to 75 days)
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: Retrospectively for 45 days prior to study enrollment, and through study completion (up to 75 days post-baseline)
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.
Time frame: Daily, through study completion (up to 75 days post-baseline)
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.
Time frame: Baseline, end of study (up to 75 days)
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.
Time frame: Baseline, end of study (up to 75 days)
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.
Time frame: weekly, through study completion (up to 75 days post-baseline)
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