Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence

Stress, Psychological Clinical Trial

— PASSION  

Official title:

Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04625465
• Other study ID #: R01AA025995
• Status: Completed
• Phase: N/A
• Start date: November 12, 2020
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: Georgia State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We will recruit sexual and gender minority couples to complete 56 days of daily surveys in order to evaluate (1) the impact of COVID-19 stress and sexual and gender minority stress on heavy episodic drinking and intimate partner violence (IPV) perpetration, and (2) a brief, mobile-phone delivered text messaging intervention to mitigate the effects of these stressors. This project has high potential to inform how pandemic stress contributes to etiological models of alcohol-related IPV perpetration in sexual and gender minority couples and inform a culturally-sensitive, low burden, and easy to disseminate intervention to mitigate these effects critical during a pandemic when access to care is limited.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria (applies to both partners):

• Both partners must identify as cisgender and sexual minority or at least one partner must identify as a gender minority (i.e., one's gender identity is non-congruent with their sex assigned at birth)
• 21 years or older
• In an intimate relationship lasting at least one month in which there are at least 2 days of face-to-face contact each week
• Consumption of 4 (assigned female at birth) or 5 (assigned male at birth) alcoholic drinks on at least three days in the past year

Exclusion Criteria:

• Seeking treatment or being in recovery for an alcohol or substance use disorder.
• Endorsement of severe physical IPV (e.g., use of a weapon) in the past year.
• Women who self-report that they are trying to get pregnant, that they are currently pregnant, or that they are currently breastfeeding .

Related Conditions & MeSH terms

• Aggression
• Alcohol Consumption
• Alcohol Drinking
• Stress, Psychological
• Violence, Domestic

Intervention

Behavioral:
• CBT Text Messaging
Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction).
• Attention Control Text Messaging
Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Georgia State University	University at Buffalo, University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intimate Partner Violence Events (Burst 1)	Participants will be asked if they experienced relationship conflict since the last report. If so, they will be asked questions about physical and/or verbal perpetration and victimization and time of occurrence.	Burst 1, Daily for 14 days
Primary	Intimate Partner Violence Events (Burst 2)	Participants will be asked if they experienced relationship conflict since the last report. If so, they will be asked questions about physical and/or verbal perpetration and victimization and time of occurrence.	Burst 2, Daily for 14 days
Primary	Intimate Partner Violence Events (Burst 3)	Participants will be asked if they experienced relationship conflict since the last report. If so, they will be asked questions about physical and/or verbal perpetration and victimization and time of occurrence.	Burst 3, Daily for 14 days
Primary	Intimate Partner Violence Events (Burst 4)	Participants will be asked if they experienced relationship conflict since the last report. If so, they will be asked questions about physical and/or verbal perpetration and victimization and time of occurrence.	Burst 4, Daily for 14 days
Primary	Drinking Episodes (Burst 1)	Participants will be asked if they consumed alcohol since the last daily report. If so, they will be asked questions about the time they drank, amount of alcohol consumed, subjective intoxication, location, with whom they drank, and illicit substance use.	Burst 1, Daily for 14 days
Primary	Drinking Episodes (Burst 2)	Participants will be asked if they consumed alcohol since the last daily report. If so, they will be asked questions about the time they drank, amount of alcohol consumed, subjective intoxication, location, with whom they drank, and illicit substance use.	Burst 2, Daily for 14 days
Primary	Drinking Episodes (Burst 3)	Participants will be asked if they consumed alcohol since the last daily report. If so, they will be asked questions about the time they drank, amount of alcohol consumed, subjective intoxication, location, with whom they drank, and illicit substance use.	Burst 3, Daily for 14 days
Primary	Drinking Episodes (Burst 4)	Participants will be asked if they consumed alcohol since the last daily report. If so, they will be asked questions about the time they drank, amount of alcohol consumed, subjective intoxication, location, with whom they drank, and illicit substance use.	Burst 4, Daily for 14 days
Secondary	Sexual or Gender Minority Stress (Burst 1)	Participants will be asked if they experienced discrimination related to their sexual or gender identity.	Burst 1, Daily for 14 days
Secondary	Sexual or Gender Minority Stress (Burst 2)	Participants will be asked if they experienced discrimination related to their sexual or gender identity.	Burst 2, Daily for 14 days
Secondary	Sexual or Gender Minority Stress (Burst 3)	Participants will be asked if they experienced discrimination related to their sexual or gender identity.	Burst 3, Daily for 14 days
Secondary	Sexual or Gender Minority Stress (Burst 4)	Participants will be asked if they experienced discrimination related to their sexual or gender identity.	Burst 4, Daily for 14 days
Secondary	COVID-19 Stress (Burst 1)	Participants will be asked if they experienced stress related to the COVID-19 pandemic.	Burst 1, Daily for 14 days
Secondary	COVID-19 Stress (Burst 2)	Participants will be asked if they experienced stress related to the COVID-19 pandemic.	Burst 2, Daily for 14 days
Secondary	COVID-19 Stress (Burst 3)	Participants will be asked if they experienced stress related to the COVID-19 pandemic.	Burst 3, Daily for 14 days
Secondary	COVID-19 Stress (Burst 4)	Participants will be asked if they experienced stress related to the COVID-19 pandemic.	Burst 4, Daily for 14 days