Back to resultsBuilding Collaborations to Address Drug Problems in the United States and China
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Cognitive Behavioral Therapy
Eligibility Criteria
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
Sites / Locations
- Meridian Health Services
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive Behavioral Therapy (CBT)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04021030
First Posted
July 12, 2019
Last Updated
April 5, 2022
Sponsor
University of Michigan
Collaborators
Michigan Medicine - PKUHSC Joint Institute for Translational and Clinical Research, Peking University, Meridian Health Services
1. Study Identification
Unique Protocol Identification Number
NCT04021030
Brief Title
Building Collaborations to Address Drug Problems in the United States and China
Official Title
Building Collaborations to Address Drug Problems in the United States and China
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
January 6, 2021 (Actual)
Study Completion Date
January 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Michigan Medicine - PKUHSC Joint Institute for Translational and Clinical Research, Peking University, Meridian Health Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Cognitive Behavioral Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy (CBT)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants with decrease in pain level ≥ 18 % (or two points) on the Numeric Rating Scale (NRS)
Description
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.
Time Frame
3 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Ilgen, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meridian Health Services
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48327
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 6 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Data access requests should be directed to Mark Ilgen (PI) at marki@umich.edu up to 36 months following article publication. To gain access, requestors will be required to sign a Data Access Agreement.
Learn more about this trial
Building Collaborations to Address Drug Problems in the United States and China
We'll reach out to this number within 24 hrs