Alcohol; Use, ProblemNCT06501677
Using EMA Data to Inform a Web-intervention for Couples Concerned About Drinking
A study testing WBI in people with Alcohol; Use, Problem, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol; Use, Problem
- What is being tested?
- WBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- report 4/5+ on the AUDIT-C
- Drinking Partners:
- in current treatment for alcohol
- concern about their CPs drinking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Karen Osilla, PhD contact
United States1 site, 1 recruiting
- Recruiting
Portland State University
Portland, Oregon, 97207
Dr. Cynthia Mohr, PhD, (503) 725-3981, cynthia.mohr@pdx.edu
Dr. Cynthia Mohr, PhD
About this study
Official title: Using Ecological Momentary Data to Inform a Web-intervention for Romantic Partners Concerned About Their Loved Ones Drinking
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.
Read the 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
- Being tested
- WBI
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBIBehavioural
Also called Partners Connect
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: WBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
DP Alcohol Use
The frequency of and amount of alcohol use, craving, and consequences experienced by the drinking partner
Measured: 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
Measured: 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
Measured: Baseline, Daily (EMA), 1-month-follow-up
Secondary outcomes (1)
CP Communication and Responsiveness about Drinking
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
Measured: Baseline, Daily (EMA), 1-month-follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start22 Apr 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol; Use, ProblemStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Portland State University
- Responsible party
- Principal investigator, Karen Osilla, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501677
- Sponsor's protocol ID
- 71858
- Status last verified
- Dec 2025
- First submitted
- 9 Jul 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Ecological Momentary Data to Inform a Web-intervention for Romantic Partners Concerned About Their Loved Ones Drinking
- ClinicalTrials.gov ID
- NCT06501677
- Acronym / sponsor ID
- 71858
- Conditions
- Alcohol; Use, Problem
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Portland State University
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: WBIWe 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. |
| Perform a pilot randomized controlled trial (RCT) comparing WBI to psychoeducation control | Active comparator | Behavioral: WBIOutcomes 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- report 4/5+ on the AUDIT-C
- in current treatment for alcohol
- concern about their CPs drinking
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 |
|---|---|---|
| WBIAlso: Partners ConnectThe 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. | Behavioural | Develop and evaluate the feasibility and acceptability of a WBI providing personalized feedback, Perform a pilot randomized controlled trial (RCT) comparing WBI to psychoeducation control |
Primary outcome
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
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
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
1 secondary outcome
CP Communication and Responsiveness about Drinking
Time frame: Baseline, Daily (EMA), 1-month-follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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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.
Karen Osilla, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WBI in people with Alcohol; Use, Problem, run by Stanford 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 10 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Nameth, BS (6505429699, knameth@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DP Alcohol Use (time frame: Baseline, Daily (EMA), 1-month-follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2026.