Using EMA Data to Inform a Web-intervention for Couples Concerned About Drinking

NCT ID: NCT06501677

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2027-08-31

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.

Detailed Description

Previous research by our team and others has shown that certain CP responses to their DP's drinking (e.g., using punishment such as expressing anger or sarcasm, or threatening to leave) lead to increased DP drinking and poorer relationship functioning. Effective CP communication may affect fluctuations in DP drinking, but its mechanism is poorly understood. Limitations of prior research include long intervals between data collection points and lack of real-time dyadic data.The proposed project will use EMA and dyadic data to identify specific CP behaviors that elicit and/or inhibit DP drinking which will directly inform a CP-focused intervention. CP-focused interventions, such as Community Reinforcement and Family Therapy (CRAFT), encourage CP positive communication and reinforcement as important tools in promoting the DP's treatment entry. The DPs of CPs receiving CRAFT are 2-3 times more likely to enter alcohol treatment compared with Al-Anon or Johnson interventions and CRAFT is also effective in improving CP mental health and relationship functioning. However, CRAFT is time- and resource-intensive (i.e., 12 in-person sessions), limiting access for CPs who lack time or are hesitant to seek help. The proposed study aims to adapt CRAFT as a new WBI developed for a community sample of CPs. In contrast to the goals of CRAFT that focus on DP treatment entry, our WBI goals focus on outcomes that may be more proximal to treatment initiation and more attainable with a WBI including improved DP drinking, CP mental health and relationship functioning. In doing so, we also target DPs with a continuum of drinking severity including those who may not need treatment. Using EMA findings that elucidate communication strategies that influence DP drinking, the WBI will include psychoeducation on interaction patterns commonly associated with DP drinking and personalized feedback based on CP baseline data to support changes in CP communication strategies. This research addresses an important problem of mitigating the adverse impact of alcohol misuse on individuals and their families. The expected outcome of this research is to leverage CP influence into an accessible, theoretically-informed intervention that will help CPs more effectively communicate with their DP for improvements to their DP's drinking behavior, their own well-being, and their relationship functioning.

Conditions

Alcohol; Use, Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

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.

Group Type: EXPERIMENTAL

WBI

Intervention Type: BEHAVIORAL

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.

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

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.

Group Type: ACTIVE_COMPARATOR

WBI

Intervention Type: BEHAVIORAL

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.

Interventions

WBI

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Partners Connect

Eligibility Criteria

Inclusion Criteria

• 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

• 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

Exclusion Criteria

• report 4/5+ on the AUDIT-C

Drinking Partners:

• in current treatment for alcohol
• concern about their CPs drinking

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Portland State University

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Karen Osilla

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Stanford, California, United States

Countries

United States

Central Contacts

Katherine Nameth, BS

Role: CONTACT

knameth@stanford.edu

6505429699

Karen Osilla, PhD

Role: CONTACT

kosilla@stanford.edu

Facility Contacts

Katherine Nameth, BS

Role: primary

knameth@stanford.edu

650-542-9699

Other Identifiers

71858

Identifier Type: -

Identifier Source: org_study_id