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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
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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 moreOther outcome measures
Exploratory Outcome Health Service Utilization
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
~4750
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,411 Previous Clinical Trials
17,461,739 Total Patients Enrolled
38 Trials studying Chronic Pain
8,138 Patients Enrolled for Chronic Pain
Patient-Centered Outcomes Research InstituteOTHER
563 Previous Clinical Trials
29,990,950 Total Patients Enrolled
9 Trials studying Chronic Pain
6,090 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have been experiencing pain for most days over the last 3 months.My average pain level in the past month has been 3 or more out of 10.
Research Study Groups:
This trial has the following groups:- Group 1: Empowered Relief
- Group 2: Online 8-session Cognitive Behavioral Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Pain Patient Testimony for trial: Trial Name: NCT05612750 — N/A
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