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

NCT04021030 | Completed

• 1 other identifier: HUM00122412
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

Behavioral: Cognitive Behavioral Therapy (CBT)

Interventions

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Inability to speak and understand English
• Inability to give informed, voluntary, written consent

Sponsors & Collaborators

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

Study Sites (1)

Meridian Health Services

Waterford, Michigan, 48327, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mark Ilgen, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 16, 2019
• Study Start: October 4, 2019
• Primary Completion: January 6, 2021
• Study Completion: January 6, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 6 months and ending 36 months following article publication.
• 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.

Locations

US (1)