Alcohol AbuseNCT02984241
E-Health Coping Skills Training for Women Whose Partner Has a Drinking Problem
A study testing eHealth Coping Skills Training, eHealth Usual Web Care and Coach Support in people with Alcohol Abuse, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This study evaluates web-based interventions to help women cope with the stress arising from living with a problem-drinking partner Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- eHealth Coping Skills Training, eHealth Usual Web Care and Coach Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2019to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resides in New York State
- Fluent in English
- Male partner has an alcohol problem
- Computer access and smart phone
- Married or cohabiting
Who cannot join
- Substance use disorder
- Serious Mental Disorder
- Participation in prior studies
- Severe relationship violence
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Research Institute on Addiction
Buffalo, New York, 14203
About this study
Official title: 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
- Conditions
- Alcohol Abuse
- Being tested
- eHealth Coping Skills Training, eHealth Usual Web Care, Coach Support
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth Coping Skills TrainingBehavioural
Access to a specialized coping skills training website
eHealth Usual Web CareBehavioural
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
Coach SupportBehavioural
Access to a professional coach by phone
| Study group | Role | What they receive |
|---|---|---|
| eHealth Coping Skills Training + Coach | Active comparator | Access to StopSpinningMyWheels.org + Coach Support Receives: Behavioral: eHealth Coping Skills Training; Behavioral: Coach Support |
| eHealth Coping Skills Training Only | Active comparator | Access to StopSpinningMyWheels.org Receives: Behavioral: eHealth Coping Skills Training |
| eHealth Usual Web Care | Active comparator | Access to StopSpinningMyWheels.org usual care Receives: Behavioral: eHealth Usual Web Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change in STAXI score up to 12 months postintervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start13 Oct 2019
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oregon
- Responsible party
- Principal investigator, Robert Rychtarik, State University of New York at Buffalo
- Investigators
- Robert G Rychtarik, Ph.D., Principal investigator, University at Buffalo, Research Institute on AddictionsBrian G. Danaher, Ph.D., Principal investigator, University of Oregon, Prevention Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984241
- Sponsor's protocol ID
- AA024118
- Status last verified
- Sep 2024
- First submitted
- 14 Nov 2016
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39208412
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EHealth Coping Skills Training for Women Whose Partner Has a Drinking Problem
- ClinicalTrials.gov ID
- NCT02984241
- Acronym / sponsor ID
- AA024118
- Conditions
- Alcohol Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- University of Oregon
- Study start
- 13 Oct 2019 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 6 Dec 2016 (estimated)
- 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.
This study evaluates web-based interventions to help women cope with the stress arising from living with a problem-drinking partner
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| eHealth Coping Skills Training + Coach | Active comparator | Behavioral: eHealth Coping Skills Training, Behavioral: Coach SupportAccess to StopSpinningMyWheels.org + Coach Support |
| eHealth Coping Skills Training Only | Active comparator | Behavioral: eHealth Coping Skills TrainingAccess to StopSpinningMyWheels.org |
| eHealth Usual Web Care | Active comparator | Behavioral: eHealth Usual Web CareAccess to StopSpinningMyWheels.org usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Resides in New York State
- Fluent in English
- Male partner has an alcohol problem
- Computer access and smart phone
- Married or cohabiting
Key exclusion criteria (4 listed)
- Substance use disorder
- Serious Mental Disorder
- Participation in prior studies
- Severe relationship violence
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 |
|---|---|---|
| eHealth Coping Skills TrainingAccess to a specialized coping skills training website | Behavioural | eHealth Coping Skills Training + Coach, eHealth Coping Skills Training Only |
| eHealth Usual Web CareAccess 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 | Behavioural | eHealth Usual Web Care |
| Coach SupportAccess to a professional coach by phone | Behavioural | eHealth Coping Skills Training + Coach |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 39208412Rychtarik 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Robert G Rychtarik, Ph.D. principal investigator
University at Buffalo, Research Institute on Addictions
Brian G. Danaher, Ph.D. principal investigator
University of Oregon, Prevention Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth Coping Skills Training, eHealth Usual Web Care and Coach Support in people with Alcohol Abuse, run by State University of New York at Buffalo 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 5 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory-II (BDI-II) Total Score (time frame: Change in BDI score up to 12 months postintervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02984241, which also lists 1 linked publication.
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 19 Sep 2024.