Clinical trial NCT03037749: Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence
Official title: Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Domestic Violence
Alcohol Consumption
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: The Mind Research Network
First posted: 2017-01-31
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a within subjects design where distressed violent and distressed nonviolent partners participated in a placebo-controlled alcohol administration study with an emotion-regulation task.
Primary purpose: BASIC_SCIENCE

Brief summary: Intimate partner violence (IPV) is a serious public health problem costing $8.3 billion per year with over $6 billion in direct medical and mental health costs alone. Alcohol is present in most incidents of IPV, and contributes to more frequent and severe IPV incidents. These facts, coupled with the fact that there are no effective interventions for IPV, make understanding mechanisms through which alcohol is associated with IPV critical.

Detailed description: Intimate partner violence (IPV) is a significant public health problem for which there are currently no effective treatments. Alcohol use is present in most instances of IPV and is associated with an increase in the frequency and severity of IPV. The investigators believe that alcohol may be related to the increase in frequency and severity of IPV through a process of over-arousal that results from the cortically and psychophysiological arousing effects of alcohol during the ascending limb of intoxication and at peak Blood Alcohol Concentration (BAC) compounded by the unique behavioral and affective patterns of violent couples. The first aim of the proposal is to determine if increases in arousal after alcohol exposure is potentiated by evocative partner stimuli and is greater for distressed violent (DV) partners than distressed nonviolent (DNV) partners. A second aim is to determine if alcohol induced arousal interferes with DV partners' ability to regulate emotion in response to evocative partner stimuli compared to DNV partners. The proposed study is an experimental comparison of the effects of alcohol on arousal and emotion regulation between 35 DV and 35 DNV partners. One partner from each DV couple will be pseudo-randomly selected and yoked to a DNV partner of the same sex and comparable relationship satisfaction for participant in the experiment. To test the overall hypothesis that over-arousal is a mechanism through which alcohol is associated with increases in the frequency and severity of IPV, the selected partners will participate in a counter-balanced placebo session and an alcohol administration session during which electroencephalography (EEG), psychophysiology and pupillary response measurements of arousal will be collected during an emotion regulation task. The data will be analyzed using a repeated measures ANOVA with a between-subjects factor. The investigators expect that DV partners will experience significantly greater arousal than DNV partners during the evocative stimuli condition. The investigators also expect that DV partners will experience greater difficulty regulating emotion during evocative stimuli than DNV partners and that this effect will be compounded during the alcohol administration condition. Findings from this study will provide firm evidence that alcohol is associated with IPV through a mechanism of over-arousal and provide key targets for intervention to prevent future IPV. The data from the current proposal will be used to test biofeedback as an adjunct to a novel behavioral intervention to reduce drinking and increase behavioral flexibility in couples with a history of IPV.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* Heterosexual,
* Be in a distressed relationship
* consume at least one to two alcoholic drinks per sitting each week for females and three to four alcoholic drinks for males
* report two binge drinking episodes (\>4 drinks for males, \>3 drinks for females) in month prior to assessment
* be married or cohabitating for at least six months
* both partners must be willing to participate
* must have a breath alcohol level of 0.0 g% at all visits.
* Distressed Violent couples must have a history of at least mild physical aggression in the past six months (e.g.,twisted partner's arm or hair).

Exclusion Criteria:

* currently separated
* an order of protection in place
* facing violence-related criminal charges
* currently in a domestic violence shelter
* evidence of psychosis or severe personality disturbance
* pregnant
* taking a medication contraindicated for use with alcohol
* currently taking insulin or oral hypoglycemic medication,
* an AUDIT score greater than 19 indicating dependent drinking
* illicit drug use (except marijuana)
* provide a positive urinalysis at first emotion-regulation session

Primary outcomes:
measure: neurophysiological arousal collected via electroencephalography
timeFrame: two years
measure: neurophysiological arousal collected via electrocardiogram
timeFrame: two years
measure: neurophysiological arousal collected via galvanic skin response
timeFrame: two years
measure: neurophysiological response collected via respiration
timeFrame: two years
measure: neurophysiological response collected via eye tracking
timeFrame: two years
measure: emotion regulation
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of Oklahoma
name: Brandi C Fink, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Mind Research Network
name: Eric D. Claus, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: