Computer Based Treatment for Cognitive Behavioral Therapy and Cooperative Pain Education and Self-Management
Completed · Not applicable
Conditions studied: Opioid Use Disorder, Chronic Pain
In brief
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 in a large and diverse sample of individuals with chronic pain treated with buprenorphine or methadone. The new program will retain key components of Dr. Carroll's computer-based training for cognitive-behavioral therapy (CBT4CBT), including its emphasis on teaching cognitive and behavioral coping skills in an engaging way and focus on the 5 A's of MAT (Adherence, Attendance, Abstinence, Alternate Activities and Accessing support); it will add components from Dr. Heapy's COPES (Cooperative Pain Education and Self-Management) intervention (self-management of chronic pain, with daily surveys via text that monitor pain intensity and interference, physical activity, and skills practice) and modify existing CBT4CBT modules to address the complex interplay between pain and drug use in this population, emphasizing the development of generalizable skills. A randomized clinical trial evaluating CBT4CBT-COPES will be conducted in a diverse sample 160 of individuals enrolled in agonist treatment (methadone or buprenorphine) who have chronic pain, in a 3-month randomized clinical trial with a 6-month follow-up, comparing it to standard treatment alone. The primary retention outcome will be adherence with agonist treatment; the primary pain outcome will be the PROMIS 6-item Pain Interference Short Form.
Key facts
- Study ID
- NCT05204576
- Run by
- Yale University
- People needed
- 160
- Starts
- 2022-07-15
- Expected to finish
- 2025-03-21
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Liberation Programs — Bridgeport, Connecticut, United States
- Connecticut Counseling Center — Danbury, Connecticut, United States
- Connecticut Counseling Centers — Waterbury, Connecticut, United States
Full record on ClinicalTrials.gov
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