Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence
Primary Purpose
Domestic Violence, Alcohol Consumption
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol beverage
Placebo beverage
Sponsored by

About this trial
This is an interventional basic science trial for Domestic Violence
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
Sites / Locations
- University of New Mexico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Distressed Violent Partners
Distressed Nonviolent Partners
Arm Description
Distressed violent partners engage in a placebo-controlled alcohol administration study with an emotion-regulation task.
Distressed nonviolent partners engage in a placebo-controlled alcohol administration study with an emotion-regulation task.
Outcomes
Primary Outcome Measures
neurophysiological arousal collected via electroencephalography
electroencephalography. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses. Greater alpha and beta frequencies relative to reduced to theta and delta frequencies indicate greater cortical arousal. The experimental conditions of this study will allow us to determine if distressed violent partners experience greater cortical arousal in certain conditions.
neurophysiological arousal collected via electrocardiogram
respiratory sinus arrythymia. This is a measure of heart rate variability that is an index of a person's ability to regulate their emotion. The responses on this measure are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.
neurophysiological arousal collected via galvanic skin response
galvanic skin response. When people are neurophysiologically aroused, their skin sweats more. This responses on this measures these changes between conditions and groups, and are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.
neurophysiological response collected via respiration
respiration. When neurophysiologically aroused people breathe faster. This responses on this measure will are evaluated against the comparison group to determine if the distressed violent group is more neurophysiologically aroused in certain experimental conditions. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.
neurophysiological response collected via eye tracking
pupillary response. When people are neurophysiologically aroused their pupils dilate. This responses on this measure are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.
emotion regulation
This is an experimental task that all participants in both the distressed violent group and the distressed nonviolent group complete. In the emotion regulation task, an comparison of the aggregated primary outcome measures will be compared between groups to determine if distressed violent participants experience greater neurophysiological arousal than distressed nonviolent participants.
Secondary Outcome Measures
Full Information
NCT ID
NCT03037749
First Posted
April 19, 2016
Last Updated
January 4, 2019
Sponsor
University of New Mexico
Collaborators
The Mind Research Network
1. Study Identification
Unique Protocol Identification Number
NCT03037749
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 27, 2015 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
The Mind Research Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Domestic Violence, Alcohol Consumption
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Distressed violent and distressed nonviolent couples participate in a placebo-controlled alcohol administration study with an emotion-regulation task.
Masking
Participant
Masking Description
Participants are given either an alcohol beverage or a placebo beverage.
Allocation
Non-Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Distressed Violent Partners
Arm Type
Experimental
Arm Description
Distressed violent partners engage in a placebo-controlled alcohol administration study with an emotion-regulation task.
Arm Title
Distressed Nonviolent Partners
Arm Type
Experimental
Arm Description
Distressed nonviolent partners engage in a placebo-controlled alcohol administration study with an emotion-regulation task.
Intervention Type
Drug
Intervention Name(s)
Alcohol beverage
Intervention Description
Alcohol beverage
Intervention Type
Drug
Intervention Name(s)
Placebo beverage
Intervention Description
Placebo beverage
Primary Outcome Measure Information:
Title
neurophysiological arousal collected via electroencephalography
Description
electroencephalography. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses. Greater alpha and beta frequencies relative to reduced to theta and delta frequencies indicate greater cortical arousal. The experimental conditions of this study will allow us to determine if distressed violent partners experience greater cortical arousal in certain conditions.
Time Frame
two years
Title
neurophysiological arousal collected via electrocardiogram
Description
respiratory sinus arrythymia. This is a measure of heart rate variability that is an index of a person's ability to regulate their emotion. The responses on this measure are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.
Time Frame
two years
Title
neurophysiological arousal collected via galvanic skin response
Description
galvanic skin response. When people are neurophysiologically aroused, their skin sweats more. This responses on this measures these changes between conditions and groups, and are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.
Time Frame
two years
Title
neurophysiological response collected via respiration
Description
respiration. When neurophysiologically aroused people breathe faster. This responses on this measure will are evaluated against the comparison group to determine if the distressed violent group is more neurophysiologically aroused in certain experimental conditions. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.
Time Frame
two years
Title
neurophysiological response collected via eye tracking
Description
pupillary response. When people are neurophysiologically aroused their pupils dilate. This responses on this measure are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.
Time Frame
two years
Title
emotion regulation
Description
This is an experimental task that all participants in both the distressed violent group and the distressed nonviolent group complete. In the emotion regulation task, an comparison of the aggregated primary outcome measures will be compared between groups to determine if distressed violent participants experience greater neurophysiological arousal than distressed nonviolent participants.
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandi C Fink, Ph.D.
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric D. Claus, Ph.D.
Organizational Affiliation
The Mind Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
12. IPD Sharing Statement
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Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence
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