Alcohol Use Disorder, Post Traumatic Stress Disorder
Conditions
Keywords
Alcohol Use Disorder, Women Veterans, Endocrinology, Cognitive Reappraisal, Microintervention, Progesterone, Posttraumatic Stress Disorder, Psychophysiology, Heart Rate Variability
Brief summary
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.
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.
Interventions
BEHAVIORALCognitive Reappraisal
This cognitive reappraisal microintervention lasts 45-60 minutes.
BEHAVIORALPsychoeducation
This psychoeducational microintervention lasts 45-60 minutes.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants will be urn randomized to either an experimental (cognitive reappraisal) or control condition.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Craving During Experimental Sessions | 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 | 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 | 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 | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCathryn Glanton Holzhauer, PhD
VA Central Western Massachusetts Healthcare System, Leeds, MA
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41 Years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 0 Participants |
| Veteran Status Non-Veterans | 7 Participants |
| Veteran Status Veterans | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 39 |
| other Total, other adverse events | 0 / 38 | 0 / 39 |
| serious Total, serious adverse events | 0 / 38 | 0 / 39 |
Outcome results
None listed