NCT01372267

Brief Summary

The present intervention is a Stage II randomized controlled efficacy trial of a group-based intervention that integrates Cognitive Behavioral Therapy (CBT) for pain and substance use disorders (SUDs) compared to a Supportive Psychoeducation Control (SPC) group in a sample of patients receiving residential SUD treatment with co-occurring chronic pain. A total of 452 patients (226 male and 226 female) with current pain rated as moderately severe or greater and comorbid drug or alcohol use disorder(s) will be recruited from a large residential SUD treatment program. These participants will be randomly assigned to either a 4-week (8-session) group of integrated CBT for pain and SUDs or a 4-week (8-session) SPC group. All participants will be re-assessed immediately post-treatment (1 month) and again at 3, 6, and 12 months post-intervention. Through this randomized controlled trial, the investigators hope to gain insight on how to improved treatment of pain in those with SUDs that could result in enhanced quality of life and improved pain-related, substance use, and other health outcomes. Evaluating a psychosocial intervention for pain and substance use that can be delivered during a SUD treatment episode would significantly extend available treatment options for the large numbers of patients with pain seen by SUD treatment providers. The investigators also hope to determine the efficacy of an evidence-based psychosocial pain management approach in men and women from a large and diverse residential addiction treatment program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 13, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

4.3 years

First QC Date

June 7, 2011

Last Update Submit

July 21, 2017

Conditions

Pain

Keywords

Cognitive Behavioral TherapyChronic PainSubstance Use DisordersPsychoeducational control group

Outcome Measures

Primary Outcomes (3)

  • Change in level of pain

    For each follow-up time point, we will subtract the baseline value to obtain a change score

    Baseline, one, three, six, twelve months

  • Change in pain tolerance

    For each follow-up time point, we will subtract the baseline value to obtain a change score

    Baseline, one, three, six, twelve months

  • Change in pain-related functioning

    For each follow-up time point, we will subtract the baseline value to obtain a change score

    Baseline, one, three, six, twelve months

Secondary Outcomes (1)

  • Change in Substance use

    Baseline, three, six, twelve months

Study Arms (2)

CBT for pain

EXPERIMENTAL
Behavioral: CBT for pain in Substance abuse

Psychoeducational control group

ACTIVE COMPARATOR

This group is designed to be an active control which provides detailed information about substance us and chronic pain without providing any CBT or other specific therapy.

Behavioral: Psychoeducation for substance abuse

Interventions

Psychoeducation for substance abuseBEHAVIORAL

This active control provides detailed educational information about substance use and chronic pain to those enrolled.

Psychoeducational control group
CBT for pain in Substance abuseBEHAVIORAL

The therapeutic intervention group is designed to provide beneficial coping strategies that are helpful in dealing with both substance use and pain.

CBT for pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be over 18 years of age
  • Report moderate to severe pain over past 3 months
  • Resided in treatment for less than 60 days

You may not qualify if:

  • Acute suicidality
  • Mental incompetence (e.g. unable to provide informed consent)
  • Evidence of current psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Programs, INC.

Waterford, Michigan, 48327, United States

Location

Related Publications (1)

  • Ilgen MA, Coughlin LN, Bohnert ASB, Chermack S, Price A, Kim HM, Jannausch M, Blow FC. Efficacy of a Psychosocial Pain Management Intervention for Men and Women With Substance Use Disorders and Chronic Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Dec 1;77(12):1225-1234. doi: 10.1001/jamapsychiatry.2020.2369.

    PMID: 32725178DERIVED

MeSH Terms

Conditions

PainChronic PainSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry, Medical School

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 13, 2011

Study Start

October 1, 2011

Primary Completion

January 1, 2016

Study Completion

April 1, 2017

Last Updated

July 24, 2017

Record last verified: 2017-07

Locations

US(1)