Clinical trial NCT04192448: Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression
Official title: The Roles of Acute Alcohol Intoxication, State Anger, and Emotion Regulation on Men's Sexual Aggression Intentions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Intoxication
Anger
Keywords: Sexual Violence
Alcohol consumption
Lead sponsor: Morehead State University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2019-12-10
Enrollment: 3
Sex: MALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study utilizes a 2x2 (Alcohol and Emotion) design in which participants will be randomly assigned to one of four groups: AlcoholxAnger, AlcoholxControl, SoberxAnger, SoberxControl
Primary purpose: BASIC_SCIENCE

Brief summary: Given the public health and social relevance of sexual aggression and the gap in the extant literature regarding state anger, emotion regulation, alcohol, and sexual aggression, the present study will contribute to our understanding of emotion regulation's role in sexual aggression perpetration. The proposed 2-year research plan will examine the effects of alcohol intoxication, state anger, and emotion regulation on men's sexual aggression intentions. This study will recruit non-monogamous, men (individuals who identify their gender as male and whose biological sex is male) who have sex with women, ages 21-35. While more research on female perpetrators is needed, the proposed study will exclusively recruit males for the following reasons: 1) the scientific literature indicating the majority of sexually aggressive acts are perpetrated by men; and 2) the current sexual aggression analog has not been piloted with female participants and would require preliminary experiments to determine its appropriateness. The study will utilize a 2x2 design in which participants are randomized to beverage condition \[alcohol (target BAC= .08gm%) or control (no alcohol control)\] and an emotion induction (anger induction or control). The outcomes will be assessed using a sexual aggression analog which participants will complete on the descending limb of alcohol intoxication and indicate the likelihood that they would engage in various sexually aggressive acts. The study also includes self-report measurements of state anger and emotion regulation to explore emotion regulation as a moderator in the associations among alcohol intoxication, state anger, and sexual aggression intentions.

Detailed description: Males ages 21 to 35 will be recruited from the community through fliers and advertisements in bars and local publications (print and electronic) and instructed to call the lab for telephone screening or complete an online web-screening survey. Sexual aggression is a pervasive and highly prevalent problem on college campuses, so the project will heavily advertise at the local college campus. The screening will include an assessment of typical alcohol consumption patterns, risk for current or past alcohol use disorder, and sexual risk-taking.

Participants (N=180) will be compensated $10 per hour of lab participation for a maximum payment of $80. Participants will begin by completing a series of background measures (see Measures) related to alcohol consumption and expectations, sexual aggression perpetration history, trait anger, and trait emotion regulation. Participants will complete factors of personality that have demonstrated associations with both emotion regulation and sexual aggression as covariates, including psychopathy, sensation seeking, and impulsivity.

Participants will be randomly assigned to receive beverages consisting of either an alcohol dose (target peak BAC =.08gm%) or a control (non-alcoholic) beverage. Participants will be informed into which alcohol condition they have been assigned. Using a double-blind procedure, participants will be block randomized by self-reported sexual aggression perpetration history \[(none = no history of perpetration) vs. (low = history of unwanted sexual contact or sexual coercion) vs. (high = attempted or completed perpetration of incapacitated or forced rape)\]. A computer algorithm will be used to assign participants to the experimental conditions such that participants with none, low, and high perpetration history are evenly distributed across beverage conditions. Individuals assigned to the alcohol condition will consume a beverage comprised of cranberry juice and 100 proof vodka, while individuals assigned to the control condition will consume a beverage comprised of cranberry juice and water. The total liquid is divided equally between three cups, and participant is given nine minutes to consume the total amount (e.g., three minutes per cup). To ensure stable absorption of alcohol and decrease the likelihood of nausea, the experimenter will instruct the participant to consume the beverages evenly and to avoid drinking quickly. Following beverage administration, participants will be Breathalyzed every five minutes until they attain two Breathalyzer readings of .08%gm to ensure their BAC will descend during the emotion induction and sexual aggression analog. A yoking procedure will be employed for control participants in which each control participant is paired with an alcohol dose participant and receive an equal number of Breathalyzer checks.

Participants will also be randomly assigned to an emotion induction condition consisting of either an anger emotion induction or a control emotion induction. This study will employ deception as individuals will not be told they have been assigned to different emotion induction conditions. The emotion induction consists of two parts: 1) an emotion recall task; and 2) provocation task. Individuals assigned to the anger induction will be instructed to recall an incident in the last 30 days when they felt angry, frustrated, or "pissed off". They will then be given five minutes to write as much as possible about that incident and their response. Participants in the control condition will be instructed to write for five minutes about a neutral topic (e.g., cooking dinner, going for a walk; Marci et al., 2007). The writing samples from all participants will be collected and coded by independent coders to identify whether participants accurately engaged in the task. Following the emotion recall portion of the induction, participants will begin a provocation task. Both groups will begin an attention task. Participants assigned to the anger condition will be given negative feedback about their performance. Participants assigned to the control condition will complete the task without feedback and then will be thanked for their participation.

Upon completion of both portions of the emotion induction, participants will read and project themselves into a written hypothetical sexual situation displayed on a computer. The stimulus story will be approximately 1,600 words and be written at a 5th grade reading level. The story will depict a sexual encounter between the participant and a hypothetical female, in which the female in the story will initially engage in consensual sexual activity however will gradually display and express resistance to engaging in intercourse. Participants will then complete assessment of outcome measures.

Immediately after completing the scenario, participants will be required to watch one of three neutral videos (e.g., comedy clips, nature documentaries) to assist with distancing and detaching from the content of the story. After completing the videos, sober participants will be debriefed and paid for their time. Intoxicated participants will be provided with food, beverages, and entertainment until their BAC descended to below .04%gm. Once their BAC has descended to below .04%gm, these participants will be debriefed and paid for their time.

Eligibility criteria: Inclusion Criteria:

* Biologically male and identify their gender as male
* Between the ages of 21-35
* Must be Interested in sexual activity with women
* Must have engaged in at least one instance of sex without a condom in the last six months
* Must on average consume between 5 and 25 standard drinks per week
* Must have previously had an instance of heavy episodic drinking (HED; at least five alcoholic drinks in two hours) in the last six months
* No history of or current alcohol problems (as determined by the Brief Michigan Alcoholism Screening Test)
* No past or current medical condition or take medications which contraindicate alcohol consumption

Exclusion Criteria:

* being in a monogamous relationship of longer than six months or not having sexual intercourse at all within the past six months
* Any history or current alcohol problems (as determined by the Brief Michigan Alcoholism Screening Test)
* Currently taking medications which contraindicate alcohol consumption
* Currently or ever diagnosed with a medical condition that contraindicates alcohol consumption
* Currently enrolled as a student at Morehead State University

Primary outcomes:
measure: Sexual Aggression Intentions
timeFrame: 20 minutes
Secondary outcomes:
measure: Physical Aggression Intentions
timeFrame: 20 minutes
measure: Psychological Aggression Intentions
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Morehead
country: United States
facility: Morehead State University
state: Kentucky
Study officials:
affiliation: Assistant Professor
name: Elizabeth C Neilson, PhD
role: PRINCIPAL_INVESTIGATOR
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