Addictive BehaviorNCT03069118
90-Day Online Substance Use Program
A study testing Treatment - Workit Health Online Program in people with Addictive Behavior and Alcohol Use Disorder, run by Workit Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Addictive Behavior, Alcohol Use Disorder, Alcohol Abuse
- What is being tested?
- Treatment - Workit Health Online Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 1 Dec 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Meghan Moynihan, PhD contact
United States1 site, 1 recruiting
- Recruiting
Workit Health
Ann Arbor, Michigan, 48103
Meghan Moynihan, PhD, meghan@workithealth.com
Lisa McLaughlin
About this study
Official title: 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.
- Being tested
- Treatment - Workit Health Online Program, Control - Resource List
- Keywords
- Telemedicine, Online Treatment, Digital Intervention
- Medical subject headings
- Behavior, Addictive, Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment - Workit Health Online ProgramBehavioural
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.
Control - Resource ListBehavioural
Tailored list of resources.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Three-month intervention on the online Workit Health platform Receives: Behavioral: Treatment - Workit Health Online Program |
| Control | Placebo comparator | A list of online resources/waitlist Receives: Behavioral: Control - Resource List |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASSIST
The Alcohol, Smoking and Substance Involvement Screening Test
Measured: 90-day
WHOQOL-BREF
World Health Organization Quality of Life (BREF) Questionnaire
Measured: 90-day
Secondary outcomes (1)
Net Promoter Score
User Satisfaction Survey
Measured: 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Feb 2017
- Primary completion1 Aug 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addictive BehaviorStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Workit Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa McLaughlin, Principal investigator, Workit Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069118
- Sponsor's protocol ID
- #2016/10/11
- Status last verified
- Feb 2017
- First submitted
- 27 Feb 2017
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Remote Behavioral Intervention and Coaching Support for Risky Substance Users in a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03069118
- Acronym / sponsor ID
- #2016/10/11
- Keywords
- Telemedicine, Online Treatment, Digital Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Workit HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Aug 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 3 Mar 2017 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Treatment - Workit Health Online ProgramThree-month intervention on the online Workit Health platform |
| Control | Placebo comparator | Behavioral: Control - Resource ListA list of online resources/waitlist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Treatment - Workit Health Online ProgramThe 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. | Behavioural | Treatment |
| Control - Resource ListTailored list of resources. | Behavioural | Control |
Primary outcome
ASSIST
Time frame: 90-day
The Alcohol, Smoking and Substance Involvement Screening Test
WHOQOL-BREF
Time frame: 90-day
World Health Organization Quality of Life (BREF) Questionnaire
1 secondary outcome
Net Promoter Score
Time frame: 90-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- 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.
Meghan Moynihan, PhD contact
Lisa McLaughlin principal investigator
Workit Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment - Workit Health Online Program in people with Addictive Behavior and Alcohol Use Disorder, run by Workit Health 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meghan Moynihan, PhD (meghan@workithealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASSIST (time frame: 90-day). 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?
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 13 Mar 2017.