NCT06501677

Brief Summary

Alcohol misuse is a prevalent and serious problem with significant harms to society, individuals, and their relationships. Romantic partners have a strong influence on their partner's behavior, uniquely positioning them as a motivator and supportive factor in changing their partner's alcohol use, but little evidence exists on the specific ways they can influence their partner. The impact this has on the quality of their relationship, communication, and overall well-being has yet to be explored. Thus, this study utilizes qualitative, quantitative, and ecological momentary assessment (EMA) data from both partners to develop a web-based intervention that applies communication-based personalized feedback to support the concerned partner (CP) in motivating their drinking partner (DP) to reduce drinking and other adverse relationship outcomes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
275

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Apr 2025Aug 2027

First Submitted

Initial submission to the registry

July 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

April 22, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 27, 2026

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

July 9, 2024

Last Update Submit

April 22, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • DP Alcohol Use

    The frequency of and amount of alcohol use, craving, and consequences experienced by the drinking partner

    Baseline, Daily (EMA), 1-month-follow-up

  • CP Well-Being

    The severity of depression and anxiety symptoms, level of anger, and perceived social support in the concerned partner

    Baseline, 1-month-follow-up

  • CP-DP Relationship Quality

    The degree of conflict and cohesion, style of communication, satisfaction, frequency of disagreement, and overall quality of the relationship

    Baseline, Daily (EMA), 1-month-follow-up

Secondary Outcomes (1)

  • CP Communication and Responsiveness about Drinking

    Baseline, Daily (EMA), 1-month-follow-up

Study Arms (3)

Identify CP communication behaviors that elicit or inhibit DP drinking using EMA

NO INTERVENTION

Couples (N=50 dyads) with one CP and one DP will be recruited from social media. Both partners will independently complete baseline and follow-up surveys. Both the CP and DP will independently complete a 21-day EMA with three daily reports on their communication and DP's drinking (craving, motives, consumption, problems). We will identify specific CP communication behaviors as proximal and long-term predictors of the DP's drinking and non-drinking. Hyp1: CP punishing drinking (e.g., yelling) will relate to increases in DP drinking. Hyp2: CP rewarding drinking (e.g., bringing alcohol home) will relate to increases in DP drinking. Hyp3: CP rewarding sobriety (e.g., planning non-drinking activities) will relate to decreases in DP drinking.

Develop and evaluate the feasibility and acceptability of a WBI providing personalized feedback

EXPERIMENTAL

We will use the Behavioral Intervention Technology Model framework to iteratively develop a four-session WBI that includes CRAFT principles and education about communication patterns learned in Aim 1. During the WBI, CPs will receive personalized feedback based on their baseline data on how their communication may influence their DP's drinking. We will evaluate the WBI's feasibility and acceptability with 15 CPs to iteratively improve the WBI.

Behavioral: WBI

Perform a pilot randomized controlled trial (RCT) comparing WBI to psychoeducation control

ACTIVE COMPARATOR

Outcomes include DP drinking (primary), CP well-being (e.g., depression, anxiety, social support), and relationship functioning (e.g., relationship distress). Although the WBI will target CPs, we will collect data from both partners (N=80 couples) at baseline and 1-month follow-up to evaluate effects. Hyp4: DP, CP, and relationship outcomes will show greater improvement in the WBI compared to control.

Behavioral: WBI

Interventions

WBIBEHAVIORAL

The WBI will comprise of four sessions focusing on CRAFT principles including: (1) self-care, (2) positive communication including ways to increase responsiveness to the DP (PPR; i.e., actively listening, showing understanding, expressing interest in what their DP is thinking and feeling, and trying to see where the DPs is coming from), (3) understanding the DP's drinking reinforcers, and (4) supporting the DP if they want help and engaging in positive, healthy activities with the DP. ' partner. Each module will take \~20-30 minutes and each session will: (1) instill optimism in CPs, (2) be solution-focused, (3) emphasize that the CP is not responsible for the DP's behaviors, and (4) use a nonjudgmental, non-confrontational, empathetic style. The WBI intervention is focused on reduced drinking in the DP and improved CP wellness.

Also known as: Partners Connect
Develop and evaluate the feasibility and acceptability of a WBI providing personalized feedbackPerform a pilot randomized controlled trial (RCT) comparing WBI to psychoeducation control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be at least 18 years of age
  • be in a romantic relationship
  • live with their partner
  • have a computer, tablet, or phone with internet access
  • have no plans to separate from partner in next 60 days
  • feel safe from partner violence

You may not qualify if:

  • report 4/5+ on the AUDIT-C
  • Drinking Partners:
  • be at least 18 years of age
  • report 4/5+ on the AUDIT-C
  • have a computer, tablet, or phone with internet access
  • feel safe from partner violence
  • in current treatment for alcohol
  • concern about their CPs drinking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portland State University

Portland, Oregon, 97207, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Katherine Nameth, BS

CONTACT

Karen Osilla, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 15, 2024

Study Start

April 22, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

April 27, 2026

Record last verified: 2025-12

Locations