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CBT vs. Empowered Relief for Chronic Pain (PROGRESS Trial)

N/A
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic pain (pain that occurs on at least half of the days of 3 months or more).
Past-month average pain intensity score of at least 3/10.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

PROGRESS Trial Summary

This trial compares two treatments for chronic pain to see which is more effective: 8-week pain-CBT or a 1-session Empowered Relief intervention.

Who is the study for?
This trial is for adults of any sex or gender with chronic pain that's been happening on most days for at least 3 months, and they feel pain intensity of at least 3 out of 10. Participants should be able to understand English, give informed consent, and follow the study plan. People with cognitive impairments, active suicidal thoughts, disruptive behavior history or who've had these treatments recently can't join.Check my eligibility
What is being tested?
The PROGRESS Study is testing two ways to help people with chronic pain: an eight-week course using Cognitive Behavioral Therapy (CBT), which involves sixteen hours total treatment time; versus a single session called Empowered Relief lasting two hours that teaches skills to manage pain.See study design
What are the potential side effects?
Since this trial focuses on education through CBT and skill sessions rather than medication, typical drug side effects are not expected. However, participants may experience emotional discomfort when discussing their experiences with chronic pain.

PROGRESS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been experiencing pain for most days over the last 3 months.
Select...
My average pain level in the past month has been 3 or more out of 10.

PROGRESS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain Intensity
Pain Interference
Secondary outcome measures
Anger
Anxiety
Depression
+6 more
Other outcome measures
Exploratory Outcome Health Service Utilization

PROGRESS Trial Design

2Treatment groups
Experimental Treatment
Group I: Online 8-session Cognitive Behavioral TherapyExperimental Treatment1 Intervention
A trained psychologist delivers 8 sessions of low-literacy CBT (the LAMP protocol) to groups of patients who were randomized to this treatment arm.
Group II: Empowered ReliefExperimental Treatment1 Intervention
A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Education
2017
N/A
~4770

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,340,122 Total Patients Enrolled
36 Trials studying Chronic Pain
8,033 Patients Enrolled for Chronic Pain
Patient-Centered Outcomes Research InstituteOTHER
550 Previous Clinical Trials
29,995,748 Total Patients Enrolled
9 Trials studying Chronic Pain
6,090 Patients Enrolled for Chronic Pain

Media Library

Education Clinical Trial Eligibility Overview. Trial Name: NCT05612750 — N/A
Chronic Pain Research Study Groups: Empowered Relief, Online 8-session Cognitive Behavioral Therapy
Chronic Pain Clinical Trial 2023: Education Highlights & Side Effects. Trial Name: NCT05612750 — N/A
Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT05612750 — N/A
Chronic Pain Patient Testimony for trial: Trial Name: NCT05612750 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the study recruiting currently?

"This trial necessitates the recruitment of 1200 eligible candidates, who can enrol at SCAN Health Plan in Long Beach and Humana in Louisville."

Answered by AI

In which geographical regions is this clinical experiment taking place?

"SCAN Health Plan in Long Beach, California, Humana in Louisville, Kentucky and Lehigh Valley Health Network in Allentown Pennsylvania are all hosting this clinical study. Additionally, 5 other medical facilities have been approved to take on patients for the trial."

Answered by AI

What objectives is this clinical trial striving to fulfill?

"This 6-month trial aims to evaluate Pain Interference, with secondary objectives of assessing Pain Catastrophizing (as measured by a 13-item scale ranging from 0-52), Anxiety (via the PROMIS Anxiety 6-item test) and Sleep Disturbance (measured using the PROMIS Sleep Disturbance 6-item)."

Answered by AI

Is this clinical trial currently enrolling participants?

"Affirmative. According to clinicaltrials.gov, this trial is still recruiting participants since it was initially posted on January 1st of 2023 and most recently modified on April 21st of the same year. Notably, 1200 individuals are needed between 5 separate sites for enrollment in the study."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
Other
California
Arizona
What site did they apply to?
Lehigh Valley Health Network
Other
Humana
Phoenix VA Health Care System
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0

What questions have other patients asked about this trial?

Is there compensation of any kind? How long and how much does it pay? How long do screening visits usually take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I have chronic pain. I am always trying to find relief from my daily pain!!
PatientReceived 1 prior treatment
I have chronic back pain, rheumatoid arthritis depression and anxiety. I've tried chiropractic, Chinese medicine, yoga yin and regular, physical therapy.
PatientReceived 1 prior treatment
I've dealt with pain all my life. Hoping this study can help alleviate this somehow.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Comparative Effectiveness of Online 8-session CBT vs. 1-Session Empowered Relief for Chronic Pain - The PROGRESS Study
Beth Darnall 2023. "Comparative Effectiveness of Online 8-session CBT vs. 1-Session Empowered Relief for Chronic Pain - The PROGRESS Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05612750.
~800 spots leftby May 2028
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