- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03069118
90-Day Online Substance Use Program
March 8, 2017 updated by: Workit Health
Effectiveness of a Remote Behavioral Intervention and Coaching Support for Risky Substance Users in a Randomized Control Trial
Individuals indicating risky substance use are randomly assigned either to a three-month online intervention on the Workit Health platform or a waitlist/treatment as usual.
Those randomized to treatment will report reduced consumption of alcohol and other drugs and higher quality of life at study conclusion.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
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 Contact
- Name: Meghan Moynihan, PhD
- Email: meghan@workithealth.com
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48103
- Recruiting
- Workit Health
-
Contact:
- Meghan Moynihan, PhD
- Email: meghan@workithealth.com
-
Principal Investigator:
- Lisa McLaughlin
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects of this research are adults who self-identify as wanting to change their relationship to alcohol or drugs, who report currently using alcohol or drugs, or having recently stopped, who have access to an internet-enabled device, who are not currently suffering from untreated acute medical or psychiatric conditions, who anticipate being able to access the intervention over a six-month period, and who are able to freely consent to participate by themselves.
Exclusion Criteria:
- Because the intervention is written for an adult audience, as well as the logistical challenges of having private access to an internet enabled device, this research is limited to participants over the age of 18.
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment
Three-month intervention on the online Workit Health platform
|
The Workit Health program is an adaptive "recovery in your pocket" harm reduction and sobriety solution that provides 24-hour access to adaptive lessons, mentorship, written and audio driven therapeutic exercises and tools, and peer-to-peer coaching.
Users access our online site and enter an initial 90-day program that takes a holistic approach to recovery by addressing the physical, mental, emotional, and social aspects of addiction.
As they advance, they move through successive levels that include lessons, activities, and assignments.
Bonus materials, such as meditations and suggested reading, give users timely opportunities to dive deeper into a problem they are struggling with that day.
Workit Health implements evidence-based strategies such as CBT, DBT, and MI.
|
PLACEBO_COMPARATOR: Control
A list of online resources/waitlist
|
Tailored list of resources.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ASSIST
Time Frame: 90-day
|
The Alcohol, Smoking and Substance Involvement Screening Test
|
90-day
|
WHOQOL-BREF
Time Frame: 90-day
|
World Health Organization Quality of Life (BREF) Questionnaire
|
90-day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Net Promoter Score
Time Frame: 90-day
|
User Satisfaction Survey
|
90-day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lisa McLaughlin, Workit Health
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)
February 1, 2017
Primary Completion (ANTICIPATED)
August 1, 2017
Study Completion (ANTICIPATED)
December 1, 2017
Study Registration Dates
First Submitted
February 27, 2017
First Submitted That Met QC Criteria
February 27, 2017
First Posted (ACTUAL)
March 3, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 13, 2017
Last Update Submitted That Met QC Criteria
March 8, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #2016/10/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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