- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06406699
Feasibility and Acceptability of Group Pain Reprocessing Therapy for Veterans With Chronic Neck/Back Pain (ESPRIT)
July 1, 2025 updated by: University of Colorado, Denver
The investigators are conducting a trial that evaluates the feasibility of telehealth group pain reprocessing therapy (PRT), with no comparison group, for the treatment of chronic back pain in a population of veterans.
PRT is a psychotherapy for chronic pain that aims to help patients reconceptualize their pain as a non-dangerous signal.
It has been shown to be effective in a previous RCT (n=151).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado - Anschutz Medical Campus VA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- At least 6 months of back pain with last week average back pain at least 4/10
- Able to attend at least 7/8 telehealth group sessions
- Access to safe living space, quite room, reliable internet, and electronic device that can be used to attend telehealth therapy sessions.
Exclusion Criteria:
- Leg pain that is worse than back pain
- Suicide attempt, SI, HI, or inpatient psychiatric hospitalization in the past 5 years
- Not receiving/has not received disability or workers compensation related to back pain in the past 2 years.
- Is not currently involved in litigation regarding chronic back pain.
- Current misuse or overuse of alcohol or drugs
- Major surgery or other major medical events in the next 6 months
- Known vertebral/spinal fracture or tumor.
- Back surgery within last 2 years
- Difficulty controlling bowel movements
- Current or recent diagnosis of cancer
- Current or recent diagnosis of severe cardiovascular disease
- Unexplained or unintended greater than 20 pound weight loss in the past year
- Diagnosis of rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, polymyositis, or other specific inflammatory disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pain Reprocessing Therapy
Participants will participate in once weekly telehealth group pain reprocessing therapy.
Sessions will last approximately 1 hour in length.
Group size will be approximately 10 individuals.
|
PRT is a psychological intervention for chronic pain patients with a primary nociplastic component.
PRT aims to help patients reconceptualize their pain as a non-dangerous signal that is not indicative of tissue pathology or structural abnormality.
Through decreasing the threat level of their chronic pain, the pain itself can also resolve.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PEG-3 Average Pain in last week
Time Frame: Baseline, Post-treatment, and 2-months post-treatment
|
0-10 scale that asks participant to rate their average pain (0=No pain, 10=Pain as bad as possible) in the last week
|
Baseline, Post-treatment, and 2-months post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 17, 2024
Primary Completion (Actual)
January 25, 2025
Study Completion (Actual)
February 8, 2025
Study Registration Dates
First Submitted
May 6, 2024
First Submitted That Met QC Criteria
May 6, 2024
First Posted (Actual)
May 9, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2025
Last Update Submitted That Met QC Criteria
July 1, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-1387
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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