NCT02984241

Brief Summary

This study evaluates web-based interventions to help women cope with the stress arising from living with a problem-drinking partner

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
2.9 years until next milestone

Study Start

First participant enrolled

October 13, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3.1 years

First QC Date

November 14, 2016

Last Update Submit

September 3, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Change in BDI score up to 12 months postintervention

  • 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.

    Change in STAXI score up to 12 months postintervention

Study Arms (3)

eHealth Coping Skills Training + Coach

ACTIVE COMPARATOR

Access to StopSpinningMyWheels.org + Coach Support

Behavioral: eHealth Coping Skills TrainingBehavioral: Coach Support

eHealth Coping Skills Training Only

ACTIVE COMPARATOR

Access to StopSpinningMyWheels.org

Behavioral: eHealth Coping Skills Training

eHealth Usual Web Care

ACTIVE COMPARATOR

Access to StopSpinningMyWheels.org usual care

Behavioral: eHealth Usual Web Care

Interventions

Access to a specialized coping skills training website

eHealth Coping Skills Training + CoacheHealth Coping Skills Training Only

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

eHealth Usual Web Care
Coach SupportBEHAVIORAL

Access to a professional coach by phone

eHealth Coping Skills Training + Coach

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resides in New York State
  • Fluent in English
  • Male partner has an alcohol problem
  • Computer access and smart phone
  • Married or cohabiting

You may not qualify if:

  • Substance use disorder
  • Serious Mental Disorder
  • Participation in prior studies
  • Severe relationship violence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Research Institute on Addiction

Buffalo, New York, 14203, United States

Location

Related Publications (1)

  • Rychtarik RG, Danaher BG, McGillicuddy NB, Tyler MS, Barrick C, Leong F, Kosty DB. Web-Based Coping Skills Training and Coach Support for Women Living With a Partner With an Alcohol Use Disorder: Randomized Controlled Trial. J Med Internet Res. 2024 Aug 29;26:e56119. doi: 10.2196/56119.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2016

First Posted

December 6, 2016

Study Start

October 13, 2019

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations