- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06845878
A Chatbot To Support Substance Use Recovery
A Conversational Agent To Support Follow-up Care For Individuals In Recovery For Substance Use Disorder
The goal of this clinical trial is to learn if/how an AI chatbot can support patients who in recovery for substance use, specifically those who are receiving medication for opioid use disorder.
Can the chatbot help lower drug use? Can the chatbot help improve clinical appointment adherence? Can the chatbot help patients build self-efficacy in leading their own recovery journey? Will the chatbot help reduce workload burden for primary care teams? Can the chatbot serve as a safe, useful and engaging tool to support patients?
Researchers will investigate the effects of using a chatbot to support follow-up care for patients in opioid use recovery.
Participants will:
- Receive access to a chatbot for 12 weeks that they can use to prepare for upcoming clinical appointments, find community resources, learn about urge-surfing and wellness techniques, and query for assistance with other recovery-related information and tasks
- Complete surveys and provide user feedback
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-65 years old
- Comfortable with reading, understanding, and communicating in English
- Receiving medication treatment for OUD at MGH?
- Able to participate in a remote interview?
- Own or have reliable access to Wi-Fi or a cellular network
- Willing to use a mobile device to access the chatbot?
Exclusion Criteria:
- Has any cognitive, visual, or auditory impairments that may prevent the participant from using the chatbot on a mobile device?
- Unstable medical condition that compromises the ability to safely participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chatbot
Participants will receive access to a chatbot for 12 weeks that can be used from a mobile device to support follow-up care and recovery needs.
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Participants will:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in SUD severity
Time Frame: 12 weeks
|
Addiction Severity Index (ASI) Drugs composite score; Scored 0-7 with higher scores indicating increasing severity
|
12 weeks
|
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Change in psychological health (Anxiety)
Time Frame: 12 weeks
|
General Anxiety Disorder-7 (GAD-7); scored 0-21 with higher scores indicating increasing anxiety
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12 weeks
|
|
Change in psychological health (Depression)
Time Frame: 12 weeks
|
Patient Health Questionnaire-8 (PHQ-8); scored 0-24 with higher scores indicating more severe depression
|
12 weeks
|
|
Change in self-efficacy for managing chronic conditions (Emotions)
Time Frame: 12 weeks
|
PROMIS Short Form 8a (Managing Emotions); scored from 8-40 with higher scores indicating higher confidence managing emotions
|
12 weeks
|
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Change in self-efficacy for managing chronic conditions (Social Interactions)
Time Frame: 12 weeks
|
PROMIS Short Form 8a (Social Interactions); scored from 8-40 with higher scores indicating higher confidence with managing social interactions
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in quality of life
Time Frame: 12 weeks
|
World Health Organization Quality of Life (WHOQoL-BREF) Assessment; higher scores indicate higher quality of life
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12 weeks
|
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Change in social needs
Time Frame: 12 weeks
|
Accountable Health Communities Health-Related Social Needs (AHC HRSN) screening; higher scores indicate higher unmet social needs
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12 weeks
|
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Chatbot usability
Time Frame: End of 12 week intervention
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Chatbot Usability Questionnaire (CUQ); scored 0-100 with higher scores indicating higher usability
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End of 12 week intervention
|
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User Satisfaction
Time Frame: End of 12 week intervention
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Net Promoter Score (NPS); scored -100 to 100 with higher scores indicating higher user satisfaction
|
End of 12 week intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Y. Xian Ho, PhD, Dimagi Inc.
- Principal Investigator: Jonathan Jackson, MEng, Dimagi Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2R44DA050218 (U.S. NIH Grant/Contract)
- 2R44DA050218-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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