NCT03445988

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

Completed NA Results posted Last updated 24 March 2025

What this trial tests

NA trial testing Cognitive Behavioral Therapy in Chronic Pain in 1,462 participants. Completed in 6 November 2023.

Timeline

24 July 2018

Primary endpoint
6 November 2023

6 November 2023

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1,462
Start date	24 July 2018
Primary completion	6 November 2023
Estimated completion	6 November 2023
Sites	1 location across United States

Drugs / interventions tested

• Cognitive Behavioral Therapy
• Chronic Pain Self Management Program
• Taper Only

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

Stanford University

Who can join

Adults 18 to 85, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Opioid Tapering Success Primary · 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 I

Group	Value	95% CI
Cognitive Behavioral Therapy for Chronic Pain (Pain-CBT)	86
Chronic Pain Self Management Program (CPSMP)	61
Taper Only (Usual Care)	81
Observational Arm (The VALUE Study)	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline, Weekly, Month 6, Monthly, and Month 12.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cognitive Behavioral Therapy for Chronic Pain (Pain-CBT)

Serious: 9/203 (4%)

Deaths: 5/203

Chronic Pain Self Management Program (CPSMP)

Serious: 7/168 (4%)

Deaths: 1/168

Taper Only (Usual Care)

Serious: 8/191 (4%)

Deaths: 2/191

Observational Arm (the VALUE Study)

Serious: 0/810 (0%)

Deaths: 4/810

Serious adverse events (17 terms)

Reaction	System	Cognitive Behavioral Thera…	Chronic Pain Self Manageme…	Taper Only (Usual Care)	Observational Arm (the VAL…
cerebrovascular accident (stroke)	Vascular disorders	—	—	—	—
Surgery - elective	Surgical and medical procedures	—	—	—	—
Car accident	Injury, poisoning and procedural complications	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Suicidal ideation	Psychiatric disorders	—	—	—	—
Differential diagnosis	General disorders	—	—	—	—
Cardiac issue	Cardiac disorders	—	—	—	—
	General disorders	—	—	—	—
Parkinson's disease	Musculoskeletal and connective tissue disorders	—	—	—	—
Progressive chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Decompensated heart failure	Cardiac disorders	—	—	—	—
Alcohol use complications	General disorders	—	—	—	—
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—
Failing kidneys	Renal and urinary disorders	—	—	—	—
Toe amputation	Surgical and medical procedures	—	—	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Cognitive Behavioral Thera…	Chronic Pain Self Manageme…	Taper Only (Usual Care)	Observational Arm (the VAL…
New medical issue	General disorders	—	—	—	—
Medical history - chronic pain	Nervous system disorders	—	—	—	—
Subjective Opiate Withdrawal Scale (SOWS)	General disorders	—	—	—	—
Emergency room visit	General disorders	—	—	—	—
Urgent care visit	General disorders	—	—	—	—
Suicidal ideation	Psychiatric disorders	—	—	—	—

Most-reported serious reactions: cerebrovascular accident (stroke), Surgery - elective, Car accident, Sepsis, Urinary tract infection, Suicidal ideation, Differential diagnosis, Cardiac issue.

Data from ClinicalTrials.gov NCT03445988 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.