Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence

Study Overview
=================
Brief 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.

Official Title
-----------------
Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence

Conditions
-----------------
Alcohol Consumption, Violence, Domestic, Stress, Psychological, Aggression

Intervention / Treatment
-----------------
* Behavioral: CBT Text Messaging
* Behavioral: Attention Control Text Messaging


Participation Criteria
=================
Eligibility Criteria
-----------------
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 .

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be enrolled into a measurement burst daily diary design comprised of four 14-day bursts of daily surveys with three 14-day intervals that do not include daily surveys. There are three intervention conditions: (A) no intervention; (B) attention-control text messaging; or (C) CBT text messaging intervention. Between bursts 1 and 2 (Interval 1), all participants will be assigned to condition A (no intervention) such that all will complete the first two bursts (28 days) before receiving an intervention. Between bursts 2 and 3 (Interval 2) and bursts 3 and 4 (Interval 3), couples will be randomized to one of the following eight patterns of conditions: AA, AB, AC, BA, BB, BC, CA, or CB. There is no CC condition because the CBT intervention is not intended to be given in multiple two-week intervals.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Intervention, No Intervention (AA)<br>Participants do not receive text messages during Interval 2 or Interval 3. | |
| Active Comparator: No Intervention, Attention-Control Texts (AB)<br>Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3. | Behavioral: Attention Control Text Messaging<br>* 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.<br>|
| Experimental: No Intervention, CBT Texts (AC)<br>Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3. | Behavioral: CBT Text Messaging<br>* 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).<br>|
| Active Comparator: Attention-Control Texts, No Intervention (BA)<br>Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3. | Behavioral: Attention Control Text Messaging<br>* 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.<br>|
| Active Comparator: Attention-Control Texts, Attention-Control Texts (BB)<br>Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3. | Behavioral: Attention Control Text Messaging<br>* 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.<br>|
| Experimental: Attention-Control Texts, CBT Texts (BC)<br>Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3. | Behavioral: CBT Text Messaging<br>* 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).<br>Behavioral: Attention Control Text Messaging<br>* 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.<br>|
| Experimental: CBT Texts, No Intervention (CA)<br>Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3. | Behavioral: CBT Text Messaging<br>* 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).<br>|
| Experimental: CBT Texts, Attention-Control Texts (CB)<br>Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3. | Behavioral: CBT Text Messaging<br>* 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).<br>Behavioral: Attention Control Text Messaging<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sexual minority, gender minority