Status:
COMPLETED
Computer Based Treatment for Cognitive Behavioral Therapy and Cooperative Pain Education and Self-Management
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Opioid Use Disorder
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators plan to develop and pilot test an integrated, web-based cognitive behavioral approach and then conduct a randomized clinical trial evaluating its efficacy relative to standard care i...
Detailed Description
Evaluate the efficacy of CBT4CBT-COPES versus standard care (treatment as usual) at 3 months (primary endpoint) among 160 individuals with OUD and chronic pain enrolled in OAT at the Liberation clinic...
Eligibility Criteria
Inclusion
- Eligible participants will be 18 years of age or older
- Meet DSM-5 criteria for OUD
- Enrolled in methadone or buprenorphine treatment at Liberation
- Have at least moderate-intensity chronic pain as indicated by a score of ≥ 4 over the past week on the 0-10 Numerical Rating Scale
- Have pain on at least half of the days of the prior six months (indicating chronicity);
- Self-reported ability to walk at least one block (for the exercise component of CBT4CBT-COPES
Exclusion
- Inability to read, write, and speak English at a third grade level (for reading informed consent)
- Untreated or inadequately treated bipolar or psychotic disorder or current suicide risk as identified by Structured Clinical Interview for DSM-5 (SCID-5)
- Life threatening health conditions that would impede participation (e.g., end stage renal failure, malignant cancer requiring chemotherapy excluding melanoma)
- Planned surgical treatment related to pain
- Pending legal action or planned relocation that makes it unlikely they would be able to complete the study
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05204576
Start Date
July 15 2022
End Date
March 21 2025
Last Update
July 23 2025
Active Locations (3)
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1
Liberation Programs
Bridgeport, Connecticut, United States, 06610
2
Connecticut Counseling Center
Danbury, Connecticut, United States, 06810
3
Connecticut Counseling Centers
Waterbury, Connecticut, United States, 06701