Stepped Care for Patients to Optimize Whole Recovery (SC-POWR)

May 14, 2024 updated by: Yale University
This is a prospective, randomized clinical trial of 316 patients with opioid use disorder (OUD) and chronic pain (CP) to test the effectiveness of treatment as usual compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce illicit opioid use and pain interference (Aim 1) and decrease alcohol use, anxiety, depression, and stress, and improve sleep (Aim 2). Eligible participants will begin medications for opioid use disorder (MOUD) and will be randomized to receive SC-POWR (i.e., cognitive behavioral therapy (CBT), MOUD, and onsite groups for exercise [Wii Fit, Tai Chi] and stress reduction [relaxation training, auricular acupuncture] for 24 weeks. Participants will be followed for another 24 weeks to evaluate durability of treatment response illicit opioid use, alcohol use, pain interference, anxiety, depression, stress, sleep, and retention in MOUD (Aim 3).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants who meet criteria for CP and OUD (N=316) will be initiated onto MOUD and randomized to 24 weeks of either treatment as usual (TAU) or 24 weeks of SC-POWR. SC-POWR patients will be "stepped up" according to a priori criteria. Patients randomized to SC-POWR will receive a behavioral intervention consisting of 12 Cognitive Behavioral Therapy (CBT) sessions over a 24 week period involving improvements in substance use and pain since baseline. Following 24 weeks of SC-POWR, patients are offered once monthly peer-support groups.

Study Type

Interventional

Enrollment (Estimated)

316

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • APT Foundation
        • Contact:
          • Phone Number: 203-215-4397
      • North Haven, Connecticut, United States, 06473

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Seeking treatment at APT Foundation
  • Receiving medications for opioid use disorder (MOUD provided by APT)
  • Have high impact chronic pain (>= 3 months duration of pain occurring most days which limits life or work activities and/or leads to inability to work)
  • Meet DSM-5 criteria for moderate to severe OUD
  • In the past 2 months, has an opioid-positive urine test or self-reports opioid use
  • Understand English
  • Able to provide informed consent

Exclusion Criteria:

  • Have pending surgery or invasive pain management procedure
  • Acutely psychotic, suicidal, or homicidal
  • Psychiatric instability (e.g., recent suicide attempt)
  • Have a contraindication to exercise (e.g. complete heart block)
  • Have a pending or planned relocation or pending incarceration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as Usual
Treatment as usual for opioid use disorder
Experimental: SC-POWR
Treatment as usual for opioid use disorder with the addition of CBT with possible stepped care to exercise and stress reduction
Behavioral: SC-POWR
Patients assigned to SC-POWR receive 12 Cognitive Behavioral Therapy (CBT) sessions over 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in composite illicit opioid use
Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48
Opioid use is measured by the Timeline Followback (TLFB) and confirmed by urine drug testing. The TLFB uses a calendar to measure opioid or other drug use over a desired time period; it is a self-reported measure of drug use. To confirm the self report, a urine test will be performed to detect the presence of opioids.
Baseline, weekly for 24 weeks, weeks 36 and 48
Change in pain interference using The Pain, Enjoyment of Life and General Activity (PEG) Scale
Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48
Pain interference is measured using the PEG scale, a 3-item scale with each item scored from 0-10. Total scores are achieved by averaging the 3 items. Total sore range from 0-10. Higher scores indicate more pain and interference.
Baseline, weekly for 24 weeks, weeks 36 and 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in alcohol use
Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48
Measured by the TLFB. The Timeline Followback for alcohol uses a calendar to record amount of alcohol consumed over a desired time period.
Baseline, weekly for 24 weeks, weeks 36 and 48
Change in sleep
Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48
Measured by a single sleep item from the Brief Pain Inventory (BPI). Higher scores mean greater pain interference with sleep.
Baseline, weekly for 24 weeks, weeks 36 and 48
Change in Anxiety symptoms using General Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48
General Anxiety Disorder- 7 (GAD-7) is a 7 item self report instrument that measures anxiety Items are scored on a 4-point scale, ranging from "not at all (0)" to "nearly everyday (3)". Item scores are summed with a total score ranging from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety.
Baseline, weekly for 24 weeks, weeks 36 and 48
Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, monthly for 24 weeks, weeks 36 and 48
PHQ-9 assesses depression symptoms. Each item asks about the frequency of specific depressive symptoms experienced over the past two weeks. The response options are scored from 0 to 3, indicating "not at all" to "nearly every day." The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms. The scoring can also be divided into categories, with scores of 0-4 indicating minimal or no depression, 5-9 indicating mild depression, 10-14 indicating moderate depression, 15-19 indicating moderately severe depression, and 20 or above indicating severe depression.
Baseline, monthly for 24 weeks, weeks 36 and 48
Change in pain intensity assessed using the Brief Pain Inventory (BPI)
Time Frame: Baseline, weekly for 24 weeks, weeks 36 and 48
The BPI has a total score range of 0-10 where: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Total pain severity score can be found by averaging all items.
Baseline, weekly for 24 weeks, weeks 36 and 48
Change in stress assessed using the Perceived Stress Scale (PSS)
Time Frame: Baseline, monthly for 24 weeks, weeks 36 and 48
The PSS is a 10-item self- report scale. PSS scores are obtained by reversing responses to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Total score range from 0-40 with higher scores indicate greater levels of stress.
Baseline, monthly for 24 weeks, weeks 36 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Declan Barry, Yale School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2023

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 13, 2021

Study Record Updates

Last Update Posted (Estimated)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000031094
  • 1RM1DA055310-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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