Cognitive Behavioral Therapy and Chronic Pain Self-Management Within the Context of Opioid Reduction: The EMPOWER Study

NCT03445988 | Completed Results DMC

• 1 other identifier: 44918
• Study Type: interventional
• Target: 1,462
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care. This project will provide patients taking opioids and physicians with the specific evidence they need to choose the most effective route to pain control, reduced pain interference, opioid reduction, and improved role function, thereby improving patient care. The aims of this study are to (1) reduce or contain prescription opioid use while maintaining pain control and (2) compare the effectiveness of the Chronic Pain Self-Management Program (CPSMP), Cognitive Behavioral Therapy for chronic pain (pain-CBT), and no behavioral treatment within the context of patient-centered collaborative opioid tapering (Taper Only). The acronym EMPOWER stands for Effective Management of Pain and Opioid-Free Ways to Enhance Relief.

Conditions

Chronic Pain

Keywords

opioid, taper, behavioral treatment for pain, randomized

Outcome Measures

Primary Outcomes (1)

• Opioid Tapering Success

  Opioid tapering success was defined as either: 50% reduction in opioid dose (change in MEDD baseline to 12 months) and no significantly increased pain (≤ 1 point increase in PROMIS pain intensity score from baseline to 12 months), or; no opioid dose increase (baseline MEDD to 12 months) and significant pain relief (≥ 2 points decrease in PROMIS pain intensity score). Pain intensity score: Patient self-reported pain intensity on 11 point (0-10) numerical rating scale where a lower score means more pain relief. MEDD: Morphine Equivalent Daily Dose. PROMIS: Patient-Reported Outcomes Measurement Information System.

  Baseline and 12 months

Study Arms (4)

Taper + Cognitive Behavioral Therapy

ACTIVE COMPARATOR

A trained psychologist delivers pain-CBT to individual patients or groups of patients with chronic pain. Group treatment is delivered across 8 weekly sessions that last for 2 hours each. Pain-CBT incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session. Pain-CBT is effective for reducing pain intensity, pain catastrophizing, depression and social impacts.

Behavioral: Cognitive Behavioral Therapy

Taper + Chronic Pain Self Management Program

ACTIVE COMPARATOR

The CPSMP is similar to pain-CBT in format and content but is peer-led, and is effective across pain conditions (e.g., back pain, arthritis) for improving pain and pain self-efficacy. The CPSMP consists of six weekly 2-hour group sessions in which two peer co-leaders provide patient education about pain, effective self-management, pain impacts, and other symptoms from a highly structured manual. Peers are people with chronic pain who live in the communities in which they teach. For this project, at least one peer facilitator per workshop will have had experience with prescription opioid use. Intervention fidelity is determined by having a trained observer with a checklist attend random workshop sessions. Similar to pain-CBT, CPSMP incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session.

Behavioral: Chronic Pain Self Management Program

Taper Only (no assigned behavioral treatment)

PLACEBO COMPARATOR

Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.

Other: Taper Only

National Observational Study (non-randomized)

NO INTERVENTION

The national observational arm of the study (the VALUE study) will enroll participants with chronic pain taking at least 10 MEDD daily. No interventions of any kind will be applied and only self-report survey data will be collected for the year following consent. EMPOWER (randomized trial) and VALUE are two independent studies. Data from the two studies will be analyzed separately.

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

A trained psychologist delivers pain-CBT to individual patients or groups of patients with chronic pain. Group treatment is delivered across 8 weekly sessions that last for 2 hours each. Pain-CBT incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session. Pain-CBT is effective for reducing pain intensity, pain catastrophizing, depression and social impacts.

Taper + Cognitive Behavioral Therapy

Chronic Pain Self Management Program BEHAVIORAL

The CPSMP is similar to pain-CBT in format and content but is peer-led, and is effective across pain conditions (e.g., back pain, arthritis) for improving pain and pain self-efficacy. The CPSMP consists of six weekly 2-hour group sessions in which two peer co-leaders provide patient education about pain, effective self-management, pain impacts, and other symptoms from a highly structured manual. Similar to pain-CBT, CPSMP incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session

Taper + Chronic Pain Self Management Program

Taper Only OTHER

Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.

Taper Only (no assigned behavioral treatment)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic non-cancer pain (≥ 6 months in duration)
• Currently receiving prescription opioids (≥ 10 MEDD) for ≥ 3 months

You may not qualify if:

• Unable to provide informed consent
• Unable to participate in group treatments in a meaningful way (e.g., evident cognitive impairment or lack of English fluency)
• Moderate to severe opioid use disorder

Sponsors & Collaborators

• Stanford University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, 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

Limitations and Caveats

COVID-related challenges resulted in a smaller sample size than was planned. Results may not generalize to those with less education or racial/ethnic diversity. Results do not generalize to patients with moderate to severe opioid use disorder, and are limited to our specific voluntary patient-centered tapering methods. The supportive and real-time responsive communication platform used across all study arms may have biased results.

Results Point of Contact

• Title: Beth Darnall, PhD
• Organization: Stanford University

bdarnall@stanford.edu

N/A

Study Officials

• Beth Darnall, Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The study manager, site coordinators, and clinicians were unblinded to group assignments, while non-clinical study investigators and statisticians remained blinded throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 26, 2018
• Study Start: July 24, 2018
• Primary Completion: November 6, 2023
• Study Completion: November 6, 2023
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)