Clinical trial NCT06670794: Using Ecological Momentary Data to Inform a Web Intervention for Romantic Partners Concerned About Their Loved Ones' Drinking
Official title: Using Ecological Momentary Data to Inform a Web Intervention for Romantic Partners Concerned About Their Loved Ones' Drinking
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Experimental
Control Condition
Keywords: alcohol
alcohol use disorder
community reinforcement and family training
concerned partners
concerned significant others
communication
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Stanford University
First posted: 2024-11-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim 1. Couples (N=50 dyads) with a Concerned Partner (CP) and a Drinking Partner (DP) will independently complete baseline and follow-up surveys and a 21-day EMA with three daily reports on their communication and DP's drinking. Aim 2. Iteratively develop a four-session web based intervention and evaluate the WBI's feasibility and acceptability with 15 CPs. Aim 3. Perform a pilot randomized controlled trial (RCT) comparing WBI to psychoeducation control in 110 couples.

Detailed description: Alcohol misuse negatively affects relationships and is significantly correlated with higher rates of relationship conflict, distress, and dissolution as well as other serious negative interpersonal consequences (e.g., domestic violence, sexual assaults). Encouragement from concerned partners (CPs) is a common motivator for those who misuse alcohol to pursue care and often the most helpful mechanism in supporting change. The goals of this proposal are to: Identify how specific CP behaviors influence their partner's alcohol craving, motives, drinking, and problems on a daily basis using dyadic ecological momentary assessment techniques (Aim 1); use the knowledge from EMA analysis to iteratively develop a CP-focused web-based intervention (WBI) that provides psychoeducation about communication patterns that influence DP drinking and by integrating personalized feedback about CPs' own communication behaviors that may be working against their goals (Aim 2); and pilot the WBI's efficacy on CP outcomes (depression, anxiety, social support), their partner's drinking behavior (alcohol consumption, motives, related consequences), and both partners' relationship distress and conflict (Aim 3). The investigators expect the WBI will yield significant improvements in all outcomes. This project is significant because intervening with CPs has strong potential to change relationship dynamics that may reduce problems and prevent future problems associated with alcohol misuse. It also develops a new prevention model that does not rely on the drinking partner attending a clinical facility to access care. The proposed study is innovative because it uses dyadic and ecological momentary assessment designs to test dynamic questions about interdependence in relationship interactions and alcohol use between partners and employs the generated knowledge to inform intervention adaptation. Teaching CPs to effectively communicate their concerns may be a necessary catalyst for decreasing their partner's alcohol use and preventing alcohol use disorders. The potential reach of this intervention is large such that it can be easily implemented over the web to those who may need help but would not otherwise seek care.

Eligibility criteria: CP Inclusion Criteria:

* be at least 18 years old
* be in a romantic relationship with their partner
* be living with their partner,
* have a computer, tablet, or mobile phone with Internet access
* have no plans to separate from their partner in the next 60 days
* indicate no concerns they would be physically hurt by their partner on the Intimate Partner Screen

CP Exclusion Criteria:

* drinking scores at or above the threshold for DP participation

DP Inclusion Criteria:

* be at least 18 years old
* misuses alcohol as defined by their scores (4+ for women/non-gender confirming, 5+ for men) on the consumption portion of the Alcohol Use Disorder Identification Test (AUDIT-C) (Dawson et al., 2005)
* has a computer, tablet, or mobile phone with Internet access
* indicates no concerns they would be physically hurt by their partner

DP Exclusion Criteria:

* current alcohol treatment
* currently concerned about their partner's drinking

Primary outcomes:
measure: CP Depression Symptoms Questionnaire
timeFrame: 1 month post-intervention.
measure: CP Anxiety Symptoms Questionnaire
timeFrame: 1 month post-intervention.
measure: CP Anger expression questionnaire
timeFrame: 1 month post-intervention.
measure: CP Loneliness Questionnaire
timeFrame: 1 month post-intervention.
measure: CP Partner Social Support Questionnaire
timeFrame: 1 month post-intervention.
measure: CP-DP Relationship Functioning Questionnaire
timeFrame: 1 month post-intervention.
measure: DP AUDIT Questionnaire
timeFrame: 1 month post-intervention.
measure: CP General Social Support Questionnaire
timeFrame: 1 month post-intervention.
measure: DP Alcohol Use Questionnaire
timeFrame: 1 month post-intervention.
measure: DP Drinking Motives Questionnaire
timeFrame: 1 month post-intervention.
measure: DP Alcohol-related Consequences Questionnaire
timeFrame: 1 month post-intervention.
Secondary outcomes:
measure: CP-DP Communication Questionnaire
timeFrame: 1 month post-intervention.
measure: CP-DP Perceived Partner Responsiveness Questionnaire
timeFrame: 1 month post-intervention.
measure: CP Communication about Drinking Questionnaire
timeFrame: 1 month post-intervention.
measure: CP-DP Communication: Number of conflicts
timeFrame: 1 month post-intervention.
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Lindsey Rodriguez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: