Acceptability and Efficacy of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back Pain

NCT05820204 | Active Not Recruiting

• 1 other identifier: 22-2162
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn which treatment works better for adults with chronic pain. This study is comparing three treatments: Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy (CBT), and usual care (whatever a person is already doing to cope with their pain). The study's main questions are:

• Does PRT work well for adults with chronic pain?
• Which treatment works better for lowering pain: PRT, CBT, or usual care? This study will compare PRT, CBT, and usual care to see which is most helpful for lowering pain and helping with other problems that people with chronic pain can have.

Conditions

Pain, Chronic; Back Pain

Keywords

chronic pain; Pain Reprocessing Therapy; Cognitive Behavioral Therapy for Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Last-week average pain intensity is assessed via the Brief Pain Inventory Short Form (BPI-SF). The BPI-SF assess pain severity and its impact on functioning. It consists of 9 total items including 4 pain items and 5 pain interference items. The 4 pain items measure pain in the last week on a numerical rating scale of 0 (no pain at all) to 10 (pain as bad as you can imagine).

  Primary time point is the day after post-treatment, 1.5 months on average

• Session Attendance

  Session attendance is a feasibility measure calculated as the proportion or percentage of people randomized to either PRT or CBT who attended at least 6 sessions.

  This value will be calculated a day after post-treatment for the last participant, approximately 1 year from the start of enrollment

Secondary Outcomes (9)

• Pain interference

  Primary time point is the day after post-treatment, 1.5 months on average

• Depression

  Primary time point is the day after post-treatment, 1.5 months on average

• Positive Affect

  Primary time point is the day after post-treatment, 1.5 months on average

• Anxiety

  Primary time point is the day after post-treatment, 1.5 months on average

• Anger

  Primary time point is the day after post-treatment, 1.5 months on average

Study Arms (3)

Pain reprocessing therapy (PRT)

EXPERIMENTAL

PRT has 5 components: 1) education about the origin of pain in the brain, its reversibility, and the pain-fear cycle; 2) reinforcing education using personal biography; 3) "somatic tracking" of pain through mindfulness and reappraisal of pain sensations as non-dangerous; 4) lowering the level of personal threat that may trigger pain sensation; and 5) inducing positive affect in periods of pain. Patients will attend 1 assessment and education telehealth session with a physician followed by 8, 50-minute, therapist-led sessions. Pacing will be flexible, ranging from 5-12 weeks, to increase accessibility. Treatment will be provided by experienced PRT clinicians. All PRT sessions will be remotely-delivered.

Behavioral: Pain reprocessing therapy (PRT)

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

ACTIVE COMPARATOR

CBT-CP, considered the leading psychological treatment for chronic pain, is a structured, time-limited intervention that aims to teach patients how to better manage chronic pain and improve their quality of life. Participants will receive 9, 50-minute sessions of CBT-CP over 5 - 12 weeks. The VA CBT-CP protocol contains an initial orientation involving education and familiarization with the CBT-CP approach to chronic pain. The protocol then includes sessions that focus on topics such as exercise, relaxation, pleasant activities, cognitive coping, and sleep. All CBT-CP sessions will be remotely-delivered.

Behavioral: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

Usual Care

ACTIVE COMPARATOR

Participants will be asked to continue whatever they are already doing to care for their back pain. Length of the usual care condition will be 5 weeks, the expected mean completion time of the PRT and CBT arms, and may be adjusted at mid-enrollment to match treatment arm length more closely.

Other: Usual care

Interventions

Pain reprocessing therapy (PRT) BEHAVIORAL

A promising new psychotherapy for chronic pain

Pain reprocessing therapy (PRT)

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) BEHAVIORAL

A psychotherapy for chronic pain that has 30+ years of research support.

Also known as: Cognitive Behavioral Therapy

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

Usual care OTHER

Participants will be asked to continue to do whatever they are currently doing to manage their pain

Also known as: Treatment as usual

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Last-week average back pain of at least 4 of 10 at the two pretreatment timepoints (online pre-screening and informed consent session)
• Back pain that is an ongoing problem for at least half the days of the last 6 months
• Back pain that is worse than leg pain.

You may not qualify if:

• Current litigation or compensation associated with pain or plans to apply for compensation or engage in litigation in the next 6 months
• Active suicidal ideation with intent, recent history of suicide attempt, or recent history of suicide attempts or self-harm behaviors within the past 5 years (including non-suicidal self-harm)
• Recent history of inpatient psychiatric hospitalization within the past 5 years
• Active, current psychosis or mania
• Active, current substance abuse, or problems with substance abuse within the past 2 years
• Instability in living conditions or major interfering life events:
• Major surgery or other major medical event planned in coming six months
• Unsure whether will reliably have suitable conditions for telehealth appointments over the next two months, including a computer or tablet, reliable fast internet, and a quiet comfortable room that is reliably available.
• Major, interfering changes in employment or housing anticipated over the next six months
• Failure to complete at least 85% (6 of 7) of EMA surveys in the first week of the study (post-consent, pre-randomization)
• Leg pain worse than back pain
• Back surgery within the last 2 years
• Difficulty controlling bladder function (to screen out cauda equina syndrome)
• Serious medical illness (e.g., current, or recent cancer diagnosis, severe cardiovascular disease)
• Recent large unexplained, unintended weight loss (20lbs or more)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Chronic Pain; Back Pain

Interventions

Cognitive Behavioral Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jonathan K. Ashar, Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: * Outcome assessment will be completed via automated transmission of a redCAP link, and as such is inherently blinded. * Fidelity assessment will be conducted by blinded fidelity assessors who are otherwise not involved in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-arm randomized control trial

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 19, 2023
• Study Start: April 12, 2023
• Primary Completion: August 25, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Complete, clean, de-identified copies of the data components described above, along with data dictionaries and metadata, will be publicly posted along with data use agreements by the online publication date of the primary aims in a peer-reviewed journal.
• Access Criteria: Data Use Agreements will ask users to not attempt to re-identify participants, either by merging in administrative, census, medical, or other data, or by using a software program that might re-identify participants. Investigators will consult as needed with the Cornell Research Data Management Service Group (RDMSG). As described in the Cornell Roybal Center overall data sharing plan, through the Cornell Roybal Center Investigator Development Program investigators will be able to access instruction and assistance to meet other requests for information that ensure research transparency and reproducibility: documentation about study aims; hypotheses/research questions; variable sources (e.g. outcome variables, covariates); measure/index construction; and publication information.

Locations

US (1)