NCT04625465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
474

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 12, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 14, 2025

Completed
Last Updated

July 14, 2025

Status Verified

June 1, 2025

Enrollment Period

3.1 years

First QC Date

November 6, 2020

Results QC Date

April 30, 2025

Last Update Submit

June 24, 2025

Conditions

Keywords

sexual minoritygender minority

Outcome Measures

Primary Outcomes (10)

  • Alcohol Use (Burst 1)

    Proportion of reporting days on which alcohol was consumed

    Burst 1, Daily for 14 days

  • Alcohol Use (Burst 2)

    Proportion of reporting days on which alcohol was consumed

    Burst 2, Daily for 14 days

  • Alcohol Use (Burst 3)

    Proportion of reporting days on which alcohol was consumed

    Burst 3, Daily for 14 days

  • Alcohol Use (Burst 4)

    Proportion of reporting days on which alcohol was consumed

    Burst 4, Daily for 14 days

  • Intimate Partner Violence (IPV) Perpetration (Burst 1)

    Proportion of reporting days on which IPV perpetration occurred

    Burst 1, Daily for 14 days

  • IPV Perpetration (Burst 2)

    Proportion of reporting days on which IPV perpetration occurred

    Burst 2, Daily for 14 days

  • IPV Perpetration (Burst 3)

    Proportion of reporting days on which IPV perpetration occurred

    Burst 3, Daily for 14 days

  • IPV Perpetration (Burst 4)

    Proportion of reporting days on which IPV perpetration occurred

    Burst 4, Daily for 14 days

  • Alcohol Use --> IPV Perpetration (Pre-Intervention)

    Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2).

    Bursts 1 and 2 (daily for 14 x 2 days)

  • Alcohol Use --> IPV Perpetration (Post-Intervention)

    Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2).

    Bursts 3 and 4 (daily for 14 x 2 days)

Secondary Outcomes (12)

  • Sexual Minority Stress (Burst 1)

    Burst 1, Daily for 14 days

  • Sexual Minority Stress (Burst 2)

    Burst 2, Daily for 14 days

  • Sexual Minority Stress (Burst 3)

    Burst 3, Daily for 14 days

  • Sexual Minority Stress (Burst 4)

    Burst 4, Daily for 14 days

  • Gender Minority Stress (Burst 1)

    Burst 1, Daily for 14 days

  • +7 more secondary outcomes

Study Arms (8)

No Intervention, No Intervention (AA)

NO INTERVENTION

Participants do not receive text messages during Interval 2 or Interval 3.

No Intervention, Attention-Control Texts (AB)

ACTIVE COMPARATOR

Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.

Behavioral: Attention Control Text Messaging

No Intervention, CBT Texts (AC)

EXPERIMENTAL

Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.

Behavioral: CBT Text Messaging

Attention-Control Texts, No Intervention (BA)

ACTIVE COMPARATOR

Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.

Behavioral: Attention Control Text Messaging

Attention-Control Texts, Attention-Control Texts (BB)

ACTIVE COMPARATOR

Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.

Behavioral: Attention Control Text Messaging

Attention-Control Texts, CBT Texts (BC)

EXPERIMENTAL

Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.

Behavioral: CBT Text MessagingBehavioral: Attention Control Text Messaging

CBT Texts, No Intervention (CA)

EXPERIMENTAL

Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.

Behavioral: CBT Text Messaging

CBT Texts, Attention-Control Texts (CB)

EXPERIMENTAL

Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.

Behavioral: CBT Text MessagingBehavioral: Attention Control Text Messaging

Interventions

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 Texts, CBT Texts (BC)CBT Texts, Attention-Control Texts (CB)CBT Texts, No Intervention (CA)No Intervention, CBT Texts (AC)

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.

Attention-Control Texts, Attention-Control Texts (BB)Attention-Control Texts, CBT Texts (BC)Attention-Control Texts, No Intervention (BA)CBT Texts, Attention-Control Texts (CB)No Intervention, Attention-Control Texts (AB)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30302, United States

Location

MeSH Terms

Conditions

Alcohol DrinkingStress, PsychologicalAggression

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorBehavioral SymptomsAberrant Motor Behavior in DementiaSocial Behavior

Results Point of Contact

Title
Dr. Dominic Parrott, Distinguished University Professor of Psychology
Organization
Georgia State University

Study Officials

  • Dominic J Parrott, Ph.D.

    Georgia State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 12, 2020

Study Start

November 12, 2020

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

July 14, 2025

Results First Posted

July 14, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

After the grant period, access to the data will be provided through the Inter-University Consortium for Political and Social Research (ICPSR). Users will be required to agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data source and funders. One year after the study is completed, all data will be compiled and organized into a single repository at ICPSR. Data will be made publicly available through ICPSR's website.

Time Frame
One year after the study is completed, all data will be compiled and organized into a single repository at ICPSR.
Access Criteria
Users will be required to agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data source and funders.

Locations