Back to resultse-Health Coping Skills Training for Women Whose Partner Has a Drinking Problem
Primary Purpose
Alcohol Abuse
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eHealth Coping Skills Training
eHealth Usual Web Care
Coach Support
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Abuse
Eligibility Criteria
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
Sites / Locations
- Clinical and Research Institute on Addiction
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
eHealth Coping Skills Training + Coach
eHealth Coping Skills Training Only
eHealth Usual Web Care
Arm Description
Access to StopSpinningMyWheels.org + Coach Support
Access to StopSpinningMyWheels.org
Access to StopSpinningMyWheels.org usual care
Outcomes
Primary Outcome Measures
Beck Depression Inventory-II (BDI-II) Total Score
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.
State-Trait Anger Expression Inventory - 2 (STAXI-2, State Anger)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02984241
First Posted
November 14, 2016
Last Updated
July 14, 2023
Sponsor
State University of New York at Buffalo
Collaborators
University of Oregon
1. Study Identification
Unique Protocol Identification Number
NCT02984241
Brief Title
e-Health Coping Skills Training for Women Whose Partner Has a Drinking Problem
Official Title
eHealth Coping Skills Training for Women Whose Partner Has a Drinking Problem
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 13, 2019 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
University of Oregon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates web-based interventions to help women cope with the stress arising from living with a problem-drinking partner
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
456 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eHealth Coping Skills Training + Coach
Arm Type
Active Comparator
Arm Description
Access to StopSpinningMyWheels.org + Coach Support
Arm Title
eHealth Coping Skills Training Only
Arm Type
Active Comparator
Arm Description
Access to StopSpinningMyWheels.org
Arm Title
eHealth Usual Web Care
Arm Type
Active Comparator
Arm Description
Access to StopSpinningMyWheels.org usual care
Intervention Type
Behavioral
Intervention Name(s)
eHealth Coping Skills Training
Intervention Description
Access to a specialized coping skills training website
Intervention Type
Behavioral
Intervention Name(s)
eHealth Usual Web Care
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Coach Support
Intervention Description
Access to a professional coach by phone
Primary Outcome Measure Information:
Title
Beck Depression Inventory-II (BDI-II) Total Score
Description
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.
Time Frame
Change in BDI score up to 12 months postintervention
Title
State-Trait Anger Expression Inventory - 2 (STAXI-2, State Anger)
Description
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.
Time Frame
Change in STAXI score up to 12 months postintervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Rychtarik, Ph.D.
Organizational Affiliation
University at Buffalo, Research Institute on Addictions
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian G. Danaher, Ph.D.
Organizational Affiliation
University of Oregon, Prevention Science Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Research Institute on Addiction
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
e-Health Coping Skills Training for Women Whose Partner Has a Drinking Problem
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