- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06501677
Using EMA Data to Inform a Web-intervention for Couples Concerned About Drinking
Using Ecological Momentary Data to Inform a Web-intervention for Romantic Partners Concerned About Their Loved Ones Drinking
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katherine Nameth, BS
- Phone Number: 6505429699
- Email: knameth@stanford.edu
Study Contact Backup
- Name: Karen Osilla, PhD
- Email: kosilla@stanford.edu
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97207
- Recruiting
- Portland State University
-
Contact:
- Dr. Cynthia Mohr, PhD
- Phone Number: (503) 725-3981
- Email: cynthia.mohr@pdx.edu
-
Principal Investigator:
- Dr. Cynthia Mohr, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Concerned Partners:
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
Exclusion Criteria:
- report 4/5+ on the AUDIT-C
Drinking Partners:
Inclusion Criteria:
- 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:
- in current treatment for alcohol
- concern about their CPs drinking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 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. |
|
|
Experimental: 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.
|
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.
Other Names:
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Active Comparator: 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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DP Alcohol Use
Time Frame: Baseline, Daily (EMA), 1-month-follow-up
|
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
Time Frame: Baseline, 1-month-follow-up
|
The severity of depression and anxiety symptoms, level of anger, and perceived social support in the concerned partner
|
Baseline, 1-month-follow-up
|
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CP-DP Relationship Quality
Time Frame: Baseline, Daily (EMA), 1-month-follow-up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CP Communication and Responsiveness about Drinking
Time Frame: Baseline, Daily (EMA), 1-month-follow-up
|
The degree to which the concerned partner employs strategies to reduce the drinking partner's drinking and the level of enablement and responsiveness towards their drinking
|
Baseline, Daily (EMA), 1-month-follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 71858
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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