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90-Day Online Substance Use Program

Primary Purpose

Addictive Behavior, Alcohol Use Disorder, Alcohol Abuse

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment - Workit Health Online Program
Control - Resource List
Sponsored by
Workit Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addictive Behavior focused on measuring Telemedicine, Online Treatment, Digital Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Workit HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Control

Arm Description

Three-month intervention on the online Workit Health platform

A list of online resources/waitlist

Outcomes

Primary Outcome Measures

ASSIST
The Alcohol, Smoking and Substance Involvement Screening Test
WHOQOL-BREF
World Health Organization Quality of Life (BREF) Questionnaire

Secondary Outcome Measures

Net Promoter Score
User Satisfaction Survey

Full Information

First Posted
February 27, 2017
Last Updated
March 8, 2017
Sponsor
Workit Health
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1. Study Identification

Unique Protocol Identification Number
NCT03069118
Brief Title
90-Day Online Substance Use Program
Official Title
Effectiveness of a Remote Behavioral Intervention and Coaching Support for Risky Substance Users in a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Anticipated)
Study Completion Date
December 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Workit Health

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addictive Behavior, Alcohol Use Disorder, Alcohol Abuse, Drug Abuse, Drug Use Disorders
Keywords
Telemedicine, Online Treatment, Digital Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Three-month intervention on the online Workit Health platform
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
A list of online resources/waitlist
Intervention Type
Behavioral
Intervention Name(s)
Treatment - Workit Health Online Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control - Resource List
Intervention Description
Tailored list of resources.
Primary Outcome Measure Information:
Title
ASSIST
Description
The Alcohol, Smoking and Substance Involvement Screening Test
Time Frame
90-day
Title
WHOQOL-BREF
Description
World Health Organization Quality of Life (BREF) Questionnaire
Time Frame
90-day
Secondary Outcome Measure Information:
Title
Net Promoter Score
Description
User Satisfaction Survey
Time Frame
90-day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan Moynihan, PhD
Email
meghan@workithealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa McLaughlin
Organizational Affiliation
Workit Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Workit Health
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Moynihan, PhD
Email
meghan@workithealth.com
First Name & Middle Initial & Last Name & Degree
Lisa McLaughlin

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

90-Day Online Substance Use Program

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