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Behavioral Intervention

Psychosocial Treatments for Chronic Pain

N/A
Recruiting
Led By John W Burns, PhD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Back/neck is primary pain location (e.g., back/neck pain greater than leg pain)
Pain interference last week is >= 3 (0 to 10 rating scale)
Must not have
Past 2 years (treated for or having experienced): Complex regional pain syndrome, Epilepsy/seizure disorder, Autoimmune disease, Liver disease, Cancer, Heart disease, Substance dependence or use disorder, Schizophrenia or other psychotic disorder, Bipolar disorder, Obsessive-compulsive disorder, Borderline personality disorder, Suicide attempt or suicide intention or impulse
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-treatment to 6-month follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve the effectiveness of psychosocial treatments for chronic musculoskeletal pain by understanding the most effective treatment mechanisms and patient-treatment matches.

Who is the study for?
This trial is for adults in the US with chronic back or neck pain that's been present most days for at least 6 months, and who are fluent in English. Participants must have internet access, a computer/tablet, and be willing to attend weekly telehealth therapy sessions. People with certain medical conditions or recent major life stressors cannot join.
What is being tested?
The study compares three psychological therapies—Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Emotional Awareness and Expression Therapy (EAET)—and usual treatment to see which is best at helping chronic spinal pain. Each therapy will be given individually over telehealth once a week for eight weeks.
What are the potential side effects?
Psychological therapies like CBT, ACT, and EAET may sometimes lead to increased emotional discomfort initially as individuals confront difficult emotions or thoughts related to their pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My main pain is in my back or neck, more than in my legs.
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My pain level last week was 3 or higher on a scale of 0 to 10.
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I am 18 years old or older.
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I have had pain for at least 3 months, occurring most days each week.
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My pain level last week was 3 or higher on a scale of 0 to 10.
Select...
I can attend weekly sessions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
In the past 2 years, I have not had any of the listed conditions or treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-treatment to 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment to 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brief Pain Inventory (BPI) - Pain Severity
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a
Secondary study objectives
American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria - 2011
Employment
Inventory of Interpersonal Problems (IIP)
+18 more
Other study objectives
Adverse Events
Behavioral Activation for Depression (BADS) - Short Form
Brain and Psychological Attributions for Pain
+14 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Treatment As UsualExperimental Treatment1 Intervention
In this control condition, participants will engage in their usual care for neck/back pain with no additional experimental intervention
Group II: Emotional Awareness and Expression TherapyExperimental Treatment1 Intervention
8-session, individual, Emotional Awareness and Expression Therapy delivered remotely by skilled EAET
Group III: Cognitive Behavioral TherapyExperimental Treatment1 Intervention
8-session, individual, Cognitive Behavioral Therapy delivered remotely by skilled CBT therapists
Group IV: Acceptance and Commitment TherapyExperimental Treatment1 Intervention
8-session, individual, Acceptance and Commitment Therapy delivered remotely by skilled ACT therapists
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emotional Awareness and Expression Therapy
2019
N/A
~260
Cognitive Behavioral Therapy
2016
Completed Phase 4
~3120
Acceptance and Commitment Therapy
2010
Completed Phase 1
~1490

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
248,904 Total Patients Enrolled
7 Trials studying Chronic Pain
1,152 Patients Enrolled for Chronic Pain
Wayne State UniversityOTHER
314 Previous Clinical Trials
110,437 Total Patients Enrolled
9 Trials studying Chronic Pain
4,482 Patients Enrolled for Chronic Pain
John W Burns, PhDPrincipal InvestigatorRush University Medical Center
2 Previous Clinical Trials
866 Total Patients Enrolled
2 Trials studying Chronic Pain
866 Patients Enrolled for Chronic Pain
~298 spots leftby Sep 2026
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