Computer Based Treatment for Cognitive Behavioral Therapy and Cooperative Pain Education and Self-Management

NCT05204576 | Completed Results DMC

• 3 other identifiers: 20000262761R61AT010619-014R33AT010619-02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Opioid Use Disorder; Chronic Pain

Keywords

Opioid-use Disorder; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Percent Participants Active in Medications for Opioid Use Disorder (MOUD) Treatment

  Participants active in MOUD treatment will be verified by TimeLine Follow-back and clinic medical records of dates of medication taken, prescriptions filled and pick up.

  At 3, 6 and 9 months post treatment

• Change in PROMIS 6-item Pain Interference Short Form

  Pain interference is measured using the PROMIS 6-item Pain Interference Short Form. The score range on the PROMIS Pain Form is 6-30, where the highest score is the highest measure of pain interference. Summed raw responses (1-5 scale per item) are converted into a standardized T-score (mean 50, SD 10), where higher scores indicate greater pain interference (worse functioning).

  Baseline and 12, 24, 36 weeks

Secondary Outcomes (2)

• Mean Days of Any Drug Use

  Baseline to Week 12

• Mean Days of Any Drug Use

  Week 12 up to Week 36

Study Arms (2)

Standard care treatment as usual (TAU)

NO INTERVENTION

Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic

CBT4CBT-Copes

EXPERIMENTAL

Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.

Behavioral: CBT4CBT COPES

Interventions

CBT4CBT COPES BEHAVIORAL

Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily IVR assessment calls

CBT4CBT-Copes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (3)

Liberation Programs

Bridgeport, Connecticut, 06610, United States

Location

Connecticut Counseling Center

Danbury, Connecticut, 06810, United States

Location

Connecticut Counseling Centers

Waterbury, Connecticut, 06701, United States

Location

Related Publications (1)

• MacLean RR, Ankawi B, Driscoll MA, Gordon MA, Frankforter TL, Nich C, Szollosy SK, Loya JM, Brito L, Ribeiro MIP, Edmond SN, Becker WC, Martino S, Sofuoglu M, Heapy AA. Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment. JMIR Res Protoc. 2024 Mar 20;13:e54342. doi: 10.2196/54342.

  PMID: 38506917 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alicia Heapy, PHD
• Organization: Yale University

alicia.heapy@yale.edu

2039325711

Study Officials

• Alicia Heapy, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: January 24, 2022
• Study Start: July 15, 2022
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)