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NCT Number: NCT03445988

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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 Only

Other

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

Primary outcomes

  1. Opioid Tapering Success

    Time frame: Baseline and 12 months

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2018
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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