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Connect2BWell for Substance Use Disorder
N/A
Waitlist Available
Research Sponsored by Pro-Change Behavior Systems
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 9 months
Awards & highlights
Study Summary
This study is evaluating whether a digital + telehealth program can help people with substance use disorders.
Eligible Conditions
- Substance Use Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Days of Use of Most Problematic Drug at 9 Months
Secondary outcome measures
Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months
Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months
Other outcome measures
Probability of Mild or Moderate Depression Relative to Greater Levels of Depression at Baseline Compared to 9 Months
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Connect2BWell ConditionExperimental Treatment1 Intervention
The Connect2BWell program delivers feedback on SUD risk, 3 brief online intervention sessions over 3 months, and text messages for 6 months. Sessions and text messages are tailored to the patient's most problematic drug based on the ASSIST; stage of change for quitting or reducing use of that drug; and stage of change for seeking treatment, if indicated. Online sessions are followed by a dashboard-guided telehealth session with a nurse care manager. The dashboard summarizes the patient's ASSIST risk scores and stage of change data; presents patients' responses to key questions in the online session; and provides tools for collaborating with the patient to select action steps matched to risk level and stage and stage of change for seeking treatment, if indicated. The program provides a patient portal with activities, resources, and tools for tracking progress on action steps.
Group II: Comparison ConditionActive Control1 Intervention
Patients assigned to the Comparison Condition will receive a brief SBIRT session delivered via telehealth by a member of their clinic care team. The session will include the clinic's standard scripted feedback matched to level of risk for alcohol use and for other drug use; encouragement to quit; and referral to specialty treatment, if indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Connect2BWell
2021
N/A
~240
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Who is running the clinical trial?
Pro-Change Behavior SystemsLead Sponsor
16 Previous Clinical Trials
14,486 Total Patients Enrolled
Community Health Center, Inc.Industry Sponsor
5 Previous Clinical Trials
1,849 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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