Stepped Care for Patients to Optimize Whole Recovery

Chronic Pain Clinical Trial

— SC-POWR  

Official title:

Stepped Care for Patients to Optimize Whole Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155163
• Other study ID #: 2000031094
• Secondary ID: 1RM1DA055310-01
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Declan Barry, PhD
• Phone: 203-285-2708
• Email: declan.barry[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Behavioral:
• SC-POWR
Patients assigned to SC-POWR receive 12 Cognitive Behavioral Therapy (CBT) sessions over 24 weeks.

Locations

Country	Name	City	State
United States	APT Foundation	New Haven	Connecticut
United States	APT Foundation	North Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in composite illicit opioid use	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
Primary	Change in pain interference using The Pain, Enjoyment of Life and General Activity (PEG) Scale	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	Change in alcohol use	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
Secondary	Change in Anxiety symptoms using General Anxiety Disorder-7 (GAD-7)	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
Secondary	Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)	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
Secondary	Change in pain intensity assessed using the Brief Pain Inventory (BPI)	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
Secondary	Change in sleep	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
Secondary	Change in stress assessed using the Perceived Stress Scale (PSS)	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