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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment to 6-month follow-up

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I can attend weekly sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment to 6-month follow-up

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brief Pain Inventory (BPI) - Pain Severity

Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a

Secondary outcome measures

American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria - 2011

Employment

Inventory of Interpersonal Problems (IIP)

+18 more

Other outcome measures

Adverse Events

Behavioral Activation for Depression (BADS) - Short Form

Brain and Psychological Attributions for Pain

+14 more

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

Cognitive Behavioral Therapy

2016

Completed Phase 4

~3120

Acceptance and Commitment Therapy

2010

Completed Phase 1

~1490

Emotional Awareness and Expression Therapy

2019

N/A

~260

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,041 Total Patients Enrolled

Wayne State UniversityOTHER

309 Previous Clinical Trials

108,815 Total Patients Enrolled

1 Trials studying Neck Pain

88 Patients Enrolled for Neck Pain

John W Burns, PhDPrincipal InvestigatorRush University Medical Center

2 Previous Clinical Trials

866 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available spots for participants in this experiment?

"As per information located on clinicaltrials.gov, this examination is not currently enrolling patients. First posted in September of 2023 and last updated a few weeks later, the trial has no open vacancies at present; however, there are 747 other studies actively seeking participants."

Answered by AI

What goals are researchers hoping to accomplish with this experiment?

"This trial will be tracked and measured from the start to post-treatment, over a 6 month follow up period, as well as on a weekly basis. The primary outcome that is being evaluated for efficacy is the Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a. Secondary outcomes include PROMIS Physical Function (SF10a), Anxiety Symptoms (SF4), and Depression Symptoms (SF4)."

Answered by AI