- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984241
e-Health Coping Skills Training for Women Whose Partner Has a Drinking Problem
July 14, 2023 updated by: Robert Rychtarik, State University of New York at Buffalo
eHealth Coping Skills Training for Women Whose Partner Has a Drinking Problem
This study evaluates web-based interventions to help women cope with the stress arising from living with a problem-drinking partner
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
456
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14203
- Clinical and Research Institute on Addiction
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Resides in New York State
- Fluent in English
- Male partner has an alcohol problem
- Computer access and smart phone
- Married or cohabiting
Exclusion Criteria:
- Substance use disorder
- Serious Mental Disorder
- Participation in prior studies
- Severe relationship violence
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: eHealth Coping Skills Training + Coach
Access to StopSpinningMyWheels.org + Coach Support
|
Access to a specialized coping skills training website
Access to a professional coach by phone
|
|
Active Comparator: eHealth Coping Skills Training Only
Access to StopSpinningMyWheels.org
|
Access to a specialized coping skills training website
|
|
Active Comparator: eHealth Usual Web Care
Access to StopSpinningMyWheels.org usual care
|
Access to a website in which helpful information on coping that is available on the internet has been systematically collected and organized in one place for easy retrieval
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory-II (BDI-II) Total Score
Time Frame: Change in BDI score up to 12 months postintervention
|
A measure of depressive symptoms.
Scores range from 0 to 63. Lower scores are indicative of better outcomes.
A score of 14 or higher is considered clinically relevant.
|
Change in BDI score up to 12 months postintervention
|
|
State-Trait Anger Expression Inventory - 2 (STAXI-2, State Anger)
Time Frame: Change in STAXI score up to 12 months postintervention
|
A measure of anger thoughts in their current state.
Scores range from 1 to 60 with lower scores representing better outcomes.
A score of 18 or above is considered clinically relevant.
|
Change in STAXI score up to 12 months postintervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Robert G Rychtarik, Ph.D., University at Buffalo, Research Institute on Addictions
- Principal Investigator: Brian G. Danaher, Ph.D., University of Oregon, Prevention Science Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2019
Primary Completion (Actual)
November 30, 2022
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
November 14, 2016
First Submitted That Met QC Criteria
December 2, 2016
First Posted (Estimated)
December 6, 2016
Study Record Updates
Last Update Posted (Actual)
July 18, 2023
Last Update Submitted That Met QC Criteria
July 14, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA024118
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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