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Computer-Based Cognitive Behavioral Therapy for Chronic Pain in Opioid Treatment (IMPACT Trial)
N/A
Recruiting
Led By Alicia Heapy, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Enrolled in methadone or buprenorphine treatment at Liberation
Eligible participants will be 18 years of age or older
Must not have
Planned surgical treatment related to pain
Life threatening health conditions that would impede participation (e.g., end stage renal failure, malignant cancer requiring chemotherapy excluding melanoma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cognitive behavioral therapy program for people with chronic pain who are also being treated with buprenorphine or methadone. The therapy program includes components from an existing program (CBT4CBT) and a new program (COPES). The trial will compare the new program to standard care in a group of 160 people, measuring outcomes such as pain interference and adherence to agonist treatment.
Who is the study for?
Adults over 18 with opioid use disorder (OUD) who are on methadone or buprenorphine treatment and have chronic pain. They must be able to walk a block, speak English at a basic level, and not have severe health issues or untreated mental disorders that could interfere with the study.
What is being tested?
The trial is testing an integrated web-based program combining cognitive-behavioral therapy (CBT4CBT) and Cooperative Pain Education Self-Management (COPES). It aims to improve adherence to medication-assisted treatment for OUD and manage chronic pain better than standard care alone.
What are the potential side effects?
Since this is a behavioral intervention involving education and self-management without medications, there may not be direct side effects like those seen with drugs. However, participants might experience discomfort while learning new coping skills.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently in a methadone or buprenorphine program at Liberation.
Select...
I am 18 years old or older.
Select...
I have experienced pain on most days for the last six months.
Select...
I have chronic pain with a severity of 4 or more on a scale of 0-10.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am scheduled for surgery to manage my pain.
Select...
I do not have any severe health conditions that would prevent me from participating.
Select...
I do not have untreated bipolar or psychotic disorders, nor am I at risk of suicide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence to opioid agonist treatment (OAT)
Change in PROMIS 6-item Pain Interference Short Form
Secondary study objectives
Drug Use
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CBT4CBT-CopesExperimental Treatment1 Intervention
Individuals will receive standard agonist treatment plus access to the CBT4CBT-COPES website plus daily texts with a link to a survey.
Group II: Standard care treatment as usual (TAU)Active Control1 Intervention
Individuals will receive buprenorphine or methadone in addition to regular individual or group sessions as offered by the clinic
Find a Location
Who is running the clinical trial?
National Center for Complementary and Integrative Health (NCCIH)NIH
854 Previous Clinical Trials
671,600 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,098 Total Patients Enrolled
Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,031,323 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for surgery to manage my pain.I do not have any severe health conditions that would prevent me from participating.You meet the official guidelines for opioid use disorder (OUD) according to the DSM-5.I do not have untreated bipolar or psychotic disorders, nor am I at risk of suicide.I am currently in a methadone or buprenorphine program at Liberation.I am 18 years old or older.I can walk at least one block by myself.I have experienced pain on most days for the last six months.I have chronic pain with a severity of 4 or more on a scale of 0-10.
Research Study Groups:
This trial has the following groups:- Group 1: Standard care treatment as usual (TAU)
- Group 2: CBT4CBT-Copes
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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