Alcohol ConsumptionPASSIONNCT04625465

Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence

A study testing CBT Text Messaging in people with Alcohol Consumption and Violence, Domestic, run by Georgia State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Alcohol Consumption, Violence, Domestic, Stress, Psychological
What is being tested?: CBT Text Messaging
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 474 participants
Where: 1 siteUnited States
Study dates: 12 Nov 2020to 15 Dec 2023
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 .

Trial locations and contacts

1 site in 1 country.

United States1 site

Georgia State University
Atlanta, Georgia, 30302

Other trials in United States

About this study

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.

Conditions: Alcohol Consumption, Violence, Domestic, Stress, Psychological, Aggression
Being tested: CBT Text Messaging, Attention Control Text Messaging
Keywords: sexual minority, gender minority
Medical subject headings: Alcohol Drinking, Stress, Psychological, Aggression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBT Text MessagingBehavioural
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 MessagingBehavioural
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.

Study groups in NCT04625465
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: CBT Text Messaging; Behavioral: 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. Receives: 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. Receives: Behavioral: CBT Text Messaging; Behavioral: Attention Control Text Messaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Alcohol Use (Burst 1)
Proportion of reporting days on which alcohol was consumed
Measured: Burst 1, Daily for 14 days
Alcohol Use (Burst 2)
Proportion of reporting days on which alcohol was consumed
Measured: Burst 2, Daily for 14 days
Alcohol Use (Burst 3)
Proportion of reporting days on which alcohol was consumed
Measured: Burst 3, Daily for 14 days
Alcohol Use (Burst 4)
Proportion of reporting days on which alcohol was consumed
Measured: Burst 4, Daily for 14 days
Intimate Partner Violence (IPV) Perpetration (Burst 1)
Proportion of reporting days on which IPV perpetration occurred
Measured: Burst 1, Daily for 14 days
IPV Perpetration (Burst 2)
Proportion of reporting days on which IPV perpetration occurred
Measured: Burst 2, Daily for 14 days
IPV Perpetration (Burst 3)
Proportion of reporting days on which IPV perpetration occurred
Measured: Burst 3, Daily for 14 days
IPV Perpetration (Burst 4)
Proportion of reporting days on which IPV perpetration occurred
Measured: 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).
Measured: 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).
Measured: Bursts 3 and 4 (daily for 14 x 2 days)

Secondary outcomes (12)

Sexual Minority Stress (Burst 1)
Total daily count across 15 daily sexual minority stress (SMS) indicators
Measured: Burst 1, Daily for 14 days
Sexual Minority Stress (Burst 2)
Total daily count across 15 daily sexual minority stress (SMS) indicators
Measured: Burst 2, Daily for 14 days
Sexual Minority Stress (Burst 3)
Total daily count across 15 daily sexual minority stress (SMS) indicators
Measured: Burst 3, Daily for 14 days
Sexual Minority Stress (Burst 4)
Total daily count across 15 daily sexual minority stress (SMS) indicators
Measured: Burst 4, Daily for 14 days
Gender Minority Stress (Burst 1)
Total daily count across 14 daily gender minority stress (GMS) indicators
Measured: Burst 1, Daily for 14 days
Gender Minority Stress (Burst 2)
Total daily count across 14 daily gender minority stress (GMS) indicators
Measured: Burst 2, Daily for 14 days
Gender Minority Stress (Burst 3)
Total daily count across 14 daily gender minority stress (GMS) indicators
Measured: Burst 3, Daily for 14 days
Gender Minority Stress (Burst 4)
Total daily count across 14 daily gender minority stress (GMS) indicators
Measured: Burst 4, Daily for 14 days
COVID Stress (Burst 1)
Average daily count of COVID stress (CS) indicators
Measured: Burst 1, Daily for 14 days
COVID Stress (Burst 2)
Average daily count of COVID stress (CS) indicators
Measured: Burst 2, Daily for 14 days
COVID Stress (Burst 3)
Average daily count of COVID stress (CS) indicators
Measured: Burst 3, Daily for 14 days
COVID Stress (Burst 4)
Average daily count of COVID stress (CS) indicators
Measured: Burst 4, Daily for 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 202015 Dec 2023

First posted12 Nov 2020
Study start12 Nov 2020
Primary completion15 Dec 2023
Study completion15 Dec 2023

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 Alcohol ConsumptionStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Crossover
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 blind
Who is masked: Participant
Enrolment: 474 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04625465
Sponsor's protocol ID: R01AA025995
Acronym: PASSION
Status last verified: Jun 2025
First submitted: 6 Nov 2020
Last updated: 14 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Alcohol Consumption trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence
ClinicalTrials.gov ID: NCT04625465
Acronym / sponsor ID: PASSION / R01AA025995
Conditions: Alcohol Consumption, Violence, Domestic, Stress, Psychological, Aggression
Keywords: sexual minority, gender minority
Study type: Interventional
Recruitment status: Completed
Enrolment: 474 participants (actual)
Lead sponsor: Georgia State UniversityUniversity, hospital or other
Collaborators: University at Buffalo, University of Louisville
Study start: 12 Nov 2020 (actual)
Primary completion: 15 Dec 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 12 Nov 2020 (actual)
Results: Posted 14 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 8
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.

Arm	Type	Receives
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	Behavioral: Attention Control Text MessagingParticipants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
No Intervention, CBT Texts (AC)	Experimental	Behavioral: CBT Text MessagingParticipants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
Attention-Control Texts, No Intervention (BA)	Active comparator	Behavioral: Attention Control Text MessagingParticipants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
Attention-Control Texts, Attention-Control Texts (BB)	Active comparator	Behavioral: Attention Control Text MessagingParticipants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
Attention-Control Texts, CBT Texts (BC)	Experimental	Behavioral: CBT Text Messaging, Behavioral: Attention Control Text MessagingParticipants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
CBT Texts, No Intervention (CA)	Experimental	Behavioral: CBT Text MessagingParticipants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
CBT Texts, Attention-Control Texts (CB)	Experimental	Behavioral: CBT Text Messaging, Behavioral: Attention Control Text MessagingParticipants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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 .

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
CBT Text MessagingOver 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).	Behavioural	Attention-Control Texts, CBT Texts (BC), CBT Texts, Attention-Control Texts (CB), CBT Texts, No Intervention (CA), No Intervention, CBT Texts (AC)
Attention Control Text MessagingOver 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.	Behavioural	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)

Primary outcome

Alcohol Use (Burst 1)
Time frame: Burst 1, Daily for 14 days
Proportion of reporting days on which alcohol was consumed
Alcohol Use (Burst 2)
Time frame: Burst 2, Daily for 14 days
Proportion of reporting days on which alcohol was consumed
Alcohol Use (Burst 3)
Time frame: Burst 3, Daily for 14 days
Proportion of reporting days on which alcohol was consumed
Alcohol Use (Burst 4)
Time frame: Burst 4, Daily for 14 days
Proportion of reporting days on which alcohol was consumed
Intimate Partner Violence (IPV) Perpetration (Burst 1)
Time frame: Burst 1, Daily for 14 days
Proportion of reporting days on which IPV perpetration occurred
IPV Perpetration (Burst 2)
Time frame: Burst 2, Daily for 14 days
Proportion of reporting days on which IPV perpetration occurred
IPV Perpetration (Burst 3)
Time frame: Burst 3, Daily for 14 days
Proportion of reporting days on which IPV perpetration occurred
IPV Perpetration (Burst 4)
Time frame: Burst 4, Daily for 14 days
Proportion of reporting days on which IPV perpetration occurred
Alcohol Use --> IPV Perpetration (Pre-Intervention)
Time frame: Bursts 1 and 2 (daily for 14 x 2 days)
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).
Alcohol Use --> IPV Perpetration (Post-Intervention)
Time frame: Bursts 3 and 4 (daily for 14 x 2 days)
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).

12 secondary outcomes

Sexual Minority Stress (Burst 1)
Time frame: Burst 1, Daily for 14 days
Sexual Minority Stress (Burst 2)
Time frame: Burst 2, Daily for 14 days
Sexual Minority Stress (Burst 3)
Time frame: Burst 3, Daily for 14 days
Sexual Minority Stress (Burst 4)
Time frame: Burst 4, Daily for 14 days
Gender Minority Stress (Burst 1)
Time frame: Burst 1, Daily for 14 days
Gender Minority Stress (Burst 2)
Time frame: Burst 2, Daily for 14 days
Gender Minority Stress (Burst 3)
Time frame: Burst 3, Daily for 14 days
Gender Minority Stress (Burst 4)
Time frame: Burst 4, Daily for 14 days
COVID Stress (Burst 1)
Time frame: Burst 1, Daily for 14 days
COVID Stress (Burst 2)
Time frame: Burst 2, Daily for 14 days
COVID Stress (Burst 3)
Time frame: Burst 3, Daily for 14 days
COVID Stress (Burst 4)
Time frame: Burst 4, Daily for 14 days

Results and safety

Results posted to the registry on 14 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Intervention, No Intervention (AA)	40	36
No Intervention, Attention-Control Texts (AB)	38	36
No Intervention, CBT Texts (AC)	76	71
Attention-Control Texts, No Intervention (BA)	40	36
Attention-Control Texts, Attention-Control Texts (BB)	40	36
Attention-Control Texts, CBT Texts (BC)	80	78
CBT Texts, No Intervention (CA)	80	80
CBT Texts, Attention-Control Texts (CB)	80	80

Primary outcome: Alcohol Use (Burst 1)

Time frame: Burst 1, Daily for 14 days. Mean (Standard Deviation). Unit: Proportion of reporting days

Measure	No Intervention, No Intervention (AA) n = 36	No Intervention, Attention-Control Texts (AB) n = 36	No Intervention, CBT Texts (AC) n = 70	Attention-Control Texts, No Intervention (BA) n = 36	Attention-Control Texts, Attention-Control Texts (BB) n = 36	Attention-Control Texts, CBT Texts (BC) n = 78	CBT Texts, No Intervention (CA) n = 80	CBT Texts, Attention-Control Texts (CB) n = 80
Value	.45 (.29)	.40 (.23)	.41 (.30)	.31 (.27)	.45 (.27)	.41 (.23)	.44 (.31)	.42 (.28)

Population analysed: 452 participants, across all arms, had reported outcome for Burst 1. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.

Primary outcome: Alcohol Use (Burst 2)

Time frame: Burst 2, Daily for 14 days. Mean (Standard Deviation). Unit: Proportion of reporting days

Measure	No Intervention, No Intervention (AA) n = 36	No Intervention, Attention-Control Texts (AB) n = 33	No Intervention, CBT Texts (AC) n = 70	Attention-Control Texts, No Intervention (BA) n = 36	Attention-Control Texts, Attention-Control Texts (BB) n = 36	Attention-Control Texts, CBT Texts (BC) n = 77	CBT Texts, No Intervention (CA) n = 80	CBT Texts, Attention-Control Texts (CB) n = 80
Value	.49 (.31)	.42 (.21)	.41 (.29)	.30 (.26)	.42 (.27)	.38 (.24)	.48 (.32)	.42 (.29)

Population analysed: Only 448 of 452 participants, across all arms, had reported outcome for Burst 2. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.

Primary outcome: Alcohol Use (Burst 3)

Time frame: Burst 3, Daily for 14 days. Mean (Standard Deviation). Unit: Proportion of reporting days

Measure	No Intervention, No Intervention (AA) n = 35	No Intervention, Attention-Control Texts (AB) n = 33	No Intervention, CBT Texts (AC) n = 63	Attention-Control Texts, No Intervention (BA) n = 35	Attention-Control Texts, Attention-Control Texts (BB) n = 35	Attention-Control Texts, CBT Texts (BC) n = 78	CBT Texts, No Intervention (CA) n = 77	CBT Texts, Attention-Control Texts (CB) n = 73
Value	.45 (.31)	.41 (.24)	.42 (.30)	.35 (.27)	.39 (.27)	.39 (.29)	.43 (.32)	.36 (.28)

Population analysed: Only 429 of 452 participants, across all arms, had reported outcome for Burst 3. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.

Primary outcome: Alcohol Use (Burst 4)

Time frame: Burst 4, Daily for 14 days. Mean (Standard Deviation). Unit: Proportion of reporting days

Measure	No Intervention, No Intervention (AA) n = 35	No Intervention, Attention-Control Texts (AB) n = 32	No Intervention, CBT Texts (AC) n = 66	Attention-Control Texts, No Intervention (BA) n = 35	Attention-Control Texts, Attention-Control Texts (BB) n = 35	Attention-Control Texts, CBT Texts (BC) n = 76	CBT Texts, No Intervention (CA) n = 79	CBT Texts, Attention-Control Texts (CB) n = 77
Value	.45 (.35)	.43 (.26)	.41 (.32)	.34 (.27)	.40 (.29)	.34 (.24)	.41 (.36)	.36 (.29)

Population analysed: Only 435 of 452 participants, across all arms, had reported outcome for Burst 4. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from the time after participants completed the baseline survey until they time they completed the fourth burst of daily diaries (i.e., approximately 14 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Intervention, No Intervention (AA)	1 of 40 (2.5%)	0 of 40 (0%)	1 of 40
No Intervention, Attention-Control Texts (AB)	0 of 38 (0%)	0 of 38 (0%)	0 of 38
No Intervention, CBT Texts (AC)	0 of 76 (0%)	0 of 76 (0%)	0 of 76
Attention-Control Texts, No Intervention (BA)	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Attention-Control Texts, Attention-Control Texts (BB)	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Attention-Control Texts, CBT Texts (BC)	0 of 80 (0%)	0 of 80 (0%)	0 of 80
CBT Texts, No Intervention (CA)	0 of 80 (0%)	0 of 80 (0%)	0 of 80
CBT Texts, Attention-Control Texts (CB)	0 of 80 (0%)	0 of 80 (0%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

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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.

Dominic J Parrott, Ph.D. principal investigator

Georgia State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CBT Text Messaging in people with Alcohol Consumption and Violence, Domestic, run by Georgia State University 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 4 inclusion and 3 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 14 Jul 2025. 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 14 Jul 2025). 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?

Alcohol Use (Burst 1) (time frame: Burst 1, Daily for 14 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04625465.

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 14 Jul 2025.