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

Conditions

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 Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Recruiting
        • Workit Health
        • Contact:
        • 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
Behavioral: Treatment - Workit Health Online Program
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
Behavioral: Control - Resource List
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

Workit Health

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

Keywords

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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