- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03037749
Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence
January 4, 2019 updated by: Brandi Fink, University of New Mexico
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- University of New Mexico
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Distressed Violent Partners
Distressed violent partners engage in a placebo-controlled alcohol administration study with an emotion-regulation task.
|
Alcohol beverage
Placebo beverage
|
Experimental: Distressed Nonviolent Partners
Distressed nonviolent partners engage in a placebo-controlled alcohol administration study with an emotion-regulation task.
|
Alcohol beverage
Placebo beverage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
neurophysiological arousal collected via electroencephalography
Time Frame: two years
|
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.
|
two years
|
neurophysiological arousal collected via electrocardiogram
Time Frame: two years
|
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.
|
two years
|
neurophysiological arousal collected via galvanic skin response
Time Frame: two years
|
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.
|
two years
|
neurophysiological response collected via respiration
Time Frame: two years
|
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.
|
two years
|
neurophysiological response collected via eye tracking
Time Frame: two years
|
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.
|
two years
|
emotion regulation
Time Frame: two years
|
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.
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Brandi C Fink, Ph.D., University of New Mexico
- Principal Investigator: Eric D. Claus, Ph.D., The Mind Research Network
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2015
Primary Completion (Actual)
August 31, 2018
Study Completion (Actual)
August 31, 2018
Study Registration Dates
First Submitted
April 19, 2016
First Submitted That Met QC Criteria
January 27, 2017
First Posted (Estimate)
January 31, 2017
Study Record Updates
Last Update Posted (Actual)
January 8, 2019
Last Update Submitted That Met QC Criteria
January 4, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-433
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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