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

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT04021030
• Collaborator: Michigan Medicine - PKUHSC Joint Institute for Translational and Clinical Research (Other), Peking University (Other), Meridian Health Services (Other)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 15.1
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: Cognitive Behavioral Therapy (CBT)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Building Collaborations to Address Drug Problems in the United States and China
• Actual Study Start Date: Oct 4, 2019
• Actual Primary Completion Date: Jan 6, 2021
• Actual Study Completion Date: Jan 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive Behavioral Therapy (CBT)	Behavioral: Cognitive Behavioral Therapy (CBT); 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.

Outcome Measures

Primary Outcome Measures

1. Proportion of participants with decrease in pain level ≥ 18 % (or two points) on the Numeric Rating Scale (NRS) [3 months post-intervention]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meridian Health Services	Waterford	Michigan	United States	48327

Sponsors and Collaborators

• University of Michigan
• Michigan Medicine - PKUHSC Joint Institute for Translational and Clinical Research
• Peking University
• Meridian Health Services

Investigators

• Principal Investigator: Mark Ilgen, Ph.D., University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark A. Ilgen, Professor of Psychiatry, University of Michigan
• ClinicalTrials.gov Identifier: NCT04021030
• Other Study ID Numbers: HUM00122412
• First Posted: Jul 16, 2019
• Last Update Posted: Apr 7, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mark A. Ilgen, Professor of Psychiatry, University of Michigan: Cognitive Behavioral Therapy
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Apr 7, 2022