Sexual AggressionNCT03159468
Emotion Regulation Interventions for Alcohol-Related Sexual Aggression
A study testing Cognitive Restructuring, Mindfulness and Alcohol consumption in people with Sexual Aggression and Heavy Drinking, run by University of Washington at 1 site in United States.
Trial summary
Rates of sexual assault are alarmingly high, and alcohol is consistently implicated in the majority of these assaults. Despite well-intentioned prevention efforts, this pandemic continues unabated, warranting the development of novel and innovative approaches to the reduction of sexual aggression. Read more about this study
- Who is it for?
- Ages 21 to 30 years, men only
- Conditions the study is for
- Sexual Aggression, Heavy Drinking
- What is being tested?
- Cognitive Restructuring, Mindfulness and Alcohol consumption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2016to 29 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Single
- Male
- Age 21-30
- Heterosexually active within past year
- Heavy episodic drinker
- Self-reported history of sexual aggression
Who cannot join
- History of alcohol problems
- Medical condition or medications that contraindicate alcohol consumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alcohol-Related Sexual Aggression: An Emotion Regulation Intervention
Rates of sexual assault are alarmingly high, and alcohol is consistently implicated in the majority of these assaults. Despite well-intentioned prevention efforts, this pandemic continues unabated, warranting the development of novel and innovative approaches to the reduction of sexual aggression. The goal of this research is to evaluate the efficacy of two brief online emotion regulation interventions for reducing alcohol-related sexual aggression in heavy episodic drinking young men with a sexual aggression history. Previous research suggests that emotion regulation difficulties are associated with both alcohol consumption and aggressive behavior. Despite the potential prevention utility of improving sexually aggressive men's emotion regulation skills in order to reduce their alcohol-related sexual aggression, this approach has yet to be explored. Thus, this study evaluates the effects of two brief online ER interventions - cognitive restructuring and mindfulness - on men's emotion regulation during a sexual aggression-related analogue. Additionally, these effects will be evaluated during both sober and intoxicated states through a laboratory- based alcohol administration experiment.
- Conditions
- Sexual Aggression, Heavy Drinking
- Being tested
- Cognitive Restructuring, Mindfulness, Alcohol consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RestructuringBehavioural
Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.
MindfulnessBehavioural
Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.
Alcohol consumptionOther
Participants consume an alcoholic beverage in the lab.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Restructuring & Alcohol Condition | Experimental | Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions. They will then consume an alcoholic beverage in the lab. Receives: Behavioral: Cognitive Restructuring; Other: Alcohol consumption |
| Mindfulness & Alcohol Condition | Experimental | Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions. They will then consume an alcoholic beverage in the lab. Receives: Behavioral: Mindfulness; Other: Alcohol consumption |
| Nutrition Information & Alcohol Condition | Experimental | Participants will receive general information about nutrition. They will then consume an alcoholic beverage in the lab. Receives: Other: Alcohol consumption |
| Cognitive Restructuring & No Alcohol Condition | Experimental | Participants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions. They will then consume a non-alcoholic beverage in the lab. Receives: Behavioral: Cognitive Restructuring |
| Mindfulness & No Alcohol Condition | Experimental | Participants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions. They will then consume a non-alcoholic beverage in the lab. Receives: Behavioral: Mindfulness |
| Nutrition Information & No Alcohol Condition | No intervention | Participants will receive general information about nutrition. They will then consume a non-alcoholic beverage in the lab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Aggression Intentions
Sexual Aggression Intentions Scale. Construct: Self-reported ratings of sexual aggression likelihood in a hypothetical scenario. Minimum value of 1 ("Very unlikely"). Maximum value of 7 ("Very likely"). Higher scores mean a worse outcome.
Measured: Within one hour after receiving the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start31 Dec 2016
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sexual AggressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Arizona State University
- Responsible party
- Principal investigator, Kelly Cue Davis, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159468
- Sponsor's protocol ID
- STUDY00002103
- Other IDs
- 1R21AA023811-01A1
- Status last verified
- Jul 2019
- First submitted
- 12 May 2017
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol-Related Sexual Aggression: An Emotion Regulation Intervention
- ClinicalTrials.gov ID
- NCT03159468
- Acronym / sponsor ID
- STUDY00002103
- Conditions
- Sexual Aggression, Heavy Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Arizona State University
- Study start
- 31 Dec 2016 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Posted 26 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rates of sexual assault are alarmingly high, and alcohol is consistently implicated in the majority of these assaults. Despite well-intentioned prevention efforts, this pandemic continues unabated, warranting the development of novel and innovative approaches to the reduction of sexual aggression. The goal of this research is to evaluate the efficacy of two brief online emotion regulation interventions for reducing alcohol-related sexual aggression in heavy episodic drinking young men with a sexual aggression history. Previous research suggests that emotion regulation difficulties are associated with both alcohol consumption and aggressive behavior. Despite the potential prevention utility of improving sexually aggressive men's emotion regulation skills in order to reduce their alcohol-related sexual aggression, this approach has yet to be explored. Thus, this study evaluates the effects of two brief online ER interventions - cognitive restructuring and mindfulness - on men's emotion regulation during a sexual aggression-related analogue. Additionally, these effects will be evaluated during both sober and intoxicated states through a laboratory- based alcohol administration experiment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cognitive Restructuring & Alcohol Condition | Experimental | Behavioral: Cognitive Restructuring, Other: Alcohol consumptionParticipants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions. They will then consume an alcoholic beverage in the lab. |
| Mindfulness & Alcohol Condition | Experimental | Behavioral: Mindfulness, Other: Alcohol consumptionParticipants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions. They will then consume an alcoholic beverage in the lab. |
| Nutrition Information & Alcohol Condition | Experimental | Other: Alcohol consumptionParticipants will receive general information about nutrition. They will then consume an alcoholic beverage in the lab. |
| Cognitive Restructuring & No Alcohol Condition | Experimental | Behavioral: Cognitive RestructuringParticipants will receive a brief online training regarding the use of cognitive restructuring skills to cope with negative emotions. They will then consume a non-alcoholic beverage in the lab. |
| Mindfulness & No Alcohol Condition | Experimental | Behavioral: MindfulnessParticipants will receive a brief online training regarding the use of mindfulness skills to cope with negative emotions. They will then consume a non-alcoholic beverage in the lab. |
| Nutrition Information & No Alcohol Condition | No intervention | –Participants will receive general information about nutrition. They will then consume a non-alcoholic beverage in the lab. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Single
- Male
- Age 21-30
- Heterosexually active within past year
- Heavy episodic drinker
Key exclusion criteria (2 listed)
- History of alcohol problems
- Medical condition or medications that contraindicate alcohol consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive RestructuringParticipants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations. | Behavioural | Cognitive Restructuring & Alcohol Condition, Cognitive Restructuring & No Alcohol Condition |
| MindfulnessParticipants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations. | Behavioural | Mindfulness & Alcohol Condition, Mindfulness & No Alcohol Condition |
| Alcohol consumptionParticipants consume an alcoholic beverage in the lab. | Other | Cognitive Restructuring & Alcohol Condition, Mindfulness & Alcohol Condition, Nutrition Information & Alcohol Condition |
Primary outcome
Sexual Aggression Intentions
Time frame: Within one hour after receiving the intervention
Sexual Aggression Intentions Scale. Construct: Self-reported ratings of sexual aggression likelihood in a hypothetical scenario. Minimum value of 1 ("Very unlikely"). Maximum value of 7 ("Very likely"). Higher scores mean a worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Restructuring, Mindfulness and Alcohol consumption in people with Sexual Aggression and Heavy Drinking, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Aggression Intentions (time frame: Within one hour after receiving the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.