Building Collaborations to Address Drug Problems in the United States and China

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact of a Cognitive Behavioral Therapy (CBT) intervention on the distribution and variability of pain level before and after intervention receipt among people with co-occurring chronic pain and Substance Use Disorders (SUDs) over a three-month follow-up period.

Detailed Description
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The project is an open trial of the CBT intervention for 20 adults receiving detoxification treatment with comorbid pain. Participants will be screened for pain and other conditions by completing a self-report survey questionnaire. Eligible participants will be asked to complete a baseline assessment. A trained research therapist will conduct individual therapy with participants twice a week for 2-4 weeks. Participants will be re-assessed at 1- and 3-month post-intervention follow-ups to track changes in their pain, functioning, and substance use.

Official Title
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Building Collaborations to Address Drug Problems in the United States and China

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Currently receiving detoxification treatment Report pain of at least moderate or greater intensity over the three months prior to baseline assessment as indicated by an average score of four or greater on the Numeric Rating Scale (NRS) Have access to a phone for confidential personal therapy after the completion of detoxification treatment. For individuals who enter the residential treatment at the facility following the detoxification treatment, a research therapist will meet with them in person at a private office at the facility during their stay due to program's restriction on phone usage. Exclusion Criteria: Inability to speak and understand English Inability to give informed, voluntary, written consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy (CBT)<br> | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* The therapeutic intervention consists of 8, one-hour individual therapy sessions delivered over the course of 2 to 4 weeks with a trained CBT therapist. These sessions are designed to provide beneficial coping strategies that are helpful in dealing with both chronic pain and substance use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with decrease in pain level ≥ 18 % (or two points) on the Numeric Rating Scale (NRS) | Pain level will be assessed using the Numeric Rating Scale (NRS). The NRS is a 0-10 scale, with higher scores indicating greater intensity of pain. | 3 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy