Matching Adults to Treatments for Chronic Pain (MATCH) Study

NCT05699252 | Active Not Recruiting DMC

• 2 other identifiers: STUDY000157711R01AT011012-01A1
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 3

Brief Summary

Chronic pain is a prevalent, disabling problem affecting as many as 50% of men and 75% of women Veterans. Cognitive Behavioral Therapy (CBT) is the current gold standard treatment for chronic pain. However, while some individuals do respond to CBT, many individuals do not obtain meaningful benefit. As a result, the average response to CBT treatment in groups of individuals with chronic pain is only modest. To address the need for effective treatments, the investigators have developed and adapted Complementary and Integrative Health (CIH) interventions such as Mindfulness-Based Cognitive Therapy (MBCT) and Hypnotic Cognitive Therapy (HYP-CT) for chronic pain management. Research shows these treatments are beneficial alternatives to CBT. However, as with CBT, response to these treatments varies, and the investigators' preliminary data suggests outcome variability is explained by a number of baseline patient factors. Research is now needed to advance knowledge regarding the pre-treatment patient factors (i.e., predictive markers) that moderate treatment outcome (i.e., patient factors that interact with treatment condition to predict outcome). The findings from this research will provide an empirical basis for developing patient-treatment matching algorithms to prospectively match a given individual to the evidence-based treatment most likely to be beneficial for them. The investigators have initiated a program of research to identify the factors that predict response to psychosocial pain treatments, including HYP-CT, MBCT, and CBT. Preliminary findings suggest that predictive markers such as brain activity (e.g., alpha and beta power, as measured by EEG), and the traits of mindfulness, hypnotizability, and catastrophizing, will predict who benefits most from different treatments. For example, post hoc analyses show that those who are "well-matched" to HYP-CT, based on the identified baseline moderators, achieve twice the amount of pain reduction with treatment, compared to those who are not well- matched. To confirm these findings, prospective research is now needed. The findings from this study will provide a foundation upon which to develop an assessment battery to identify critical values on which to base algorithms for a priori matching of individual patients to different treatments. This has the potential to substantially boost the typically modest average effect sizes that are achieved when using a more traditional "one size fits all" approach.

Conditions

Chronic Pain

Keywords

chronic pain; cognitive behavioral therapy; hypnotic cognitive therapy; mindfulness-based cognitive therapy

Outcome Measures

Primary Outcomes (1)

• Change in Average Daily Pain Intensity

  Change in pain intensity will be measured using a 0-10 numerical rating scale (NRS) of average pain in the past 24 hours, up to 4 times within a 7-day period. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity.

  Assessed online up to 4 times within a 7-day period at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.

Secondary Outcomes (17)

• Change in Depression

  Assessed online at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.

• Change in Anxiety

  Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.

• Change in Sleep Quality

  Assessed online at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.

• Change in Pain Interference

  Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.

• Change in Fatigue

  Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.

Study Arms (4)

Cognitive Behavioral Therapy (CBT) condition

ACTIVE COMPARATOR

Participants randomized to this arm will be taught about the role of cognitions (particularly pain catastrophizing), pain beliefs (including perceived control), and maladaptive or unhelpful coping behaviors in chronic pain. This technique will help participants: (1) identify and change or restructure unhelpful or negative thinking about pain; (2) utilize positive coping strategies including positive coping self-statements; relaxation techniques; behavioral activation (including setting goals for activation), activity pacing and scheduling; and (3) cope with pain flare-ups.

Behavioral: Cognitive Behavioral Therapy (CBT)

Hypnotic Cognitive Therapy (HYP-CT) condition

EXPERIMENTAL

Participants randomized to this arm will be taught about the role of hypnosis to reduce pain, increase comfort and well-being, and to instill and reinforce healthy, adaptive cognitions. This technique will help participants to use their ability to enter a state of focused attention to then increase their acceptance of new adaptive ideas about pain provided both by (1) clinicians during sessions and on audio recordings, as well as (2) the participants themselves during self-hypnosis practice.

Behavioral: Hypnotic Cognitive Therapy (HYP-CT)

Mindfulness-Based Cognitive Therapy (MBCT) condition

EXPERIMENTAL

Participants randomized to this arm will be taught about the role of MBCT in training the mind to respond more adaptively to pain. This technique will help participants: (1) apply the skills they learn not only to pain but also to the problems pain causes for them, including sleep disturbance, depressed mood, stress, and other problems; (2) build on their strengths and their innate ability to focus their attention at will, and to use this ability to mindfully perceive experience in a non-judgmental, non-reactive way; and (3) notice their moment-to-moment experience and to shift their relationship to this experience. With enhanced mindful awareness comes the opportunity to then mindfully choose how to respond to the pain in a way that reduces stress and is most helpful or adaptive.

Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Usual Care (UC) Control Group condition

NO INTERVENTION

In the Usual Care condition, participants will not participate in a study treatment, but rather they will continue with their usual care for chronic pain and will complete the seven study assessment sets. At the end of the study, after the final 6-month follow-up assessment period, participants will be given the opportunity to receive any one of the three treatments that they would like as part of an open label phase of the study UNLESS participants have developed new problems that would make them ineligible.

Interventions

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

The CBT intervention will be used to help participants learn about the role of cognitions (particularly pain catastrophizing), pain beliefs (including perceived control), and maladaptive or unhelpful coping behaviors in chronic pain. This technique will help participants: (1) identify and change or restructure unhelpful or negative thinking about pain; (2) utilize positive coping strategies including positive coping self-statements; relaxation techniques; behavioral activation (including setting goals for activation), activity pacing and scheduling; and (3) cope with pain flare-ups.

Cognitive Behavioral Therapy (CBT) condition

Hypnotic Cognitive Therapy (HYP-CT) BEHAVIORAL

The HYP-CT intervention will be used to help participants learn about the role of hypnosis to reduce pain, increase comfort and well-being, and to instill and reinforce healthy, adaptive cognitions. This technique will help participants to use their ability to enter a state of focused attention to then increase their acceptance of new adaptive ideas about pain provided both by (1) clinicians during sessions and on audio recordings, as well as (2) the participants themselves during self-hypnosis practice.

Hypnotic Cognitive Therapy (HYP-CT) condition

Mindfulness-Based Cognitive Therapy (MBCT) BEHAVIORAL

The MBCT intervention will be used to help participants learn about the role of MBCT in training the mind to respond more adaptively to pain. This technique will help participants: (1) apply the skills they learn not only to pain but also to the problems pain causes for them, including sleep disturbance, depressed mood, stress, and other problems; (2) build on their strengths and their innate ability to focus their attention at will, and to use this ability to mindfully perceive experience in a non-judgmental, non-reactive way; and (3) notice their moment-to-moment experience and to shift their relationship to this experience. With enhanced mindful awareness comes the opportunity to then mindfully choose how to respond to the pain in a way that reduces stress and is most helpful or adaptive.

Mindfulness-Based Cognitive Therapy (MBCT) condition

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years old.
• Having chronic pain, operationalized as average pain intensity in the last week rated as ≥ 3 on a 0-10 Numerical Rating Scale (NRS) and having pain on most days for 3 months or more.
• Able to read, speak, and understand English.
• Willingness to be randomized to condition and use videoconferencing with audio and video enabled.
• Access to a private place with adequate internet reception to support participation in videoconferencing treatment sessions.
• Not currently participating in another clinical trial or interventional study for chronic pain and willing to refrain from participation in any other clinical trial or interventional study for chronic pain during active participation in this study.
• Willing, able, and committed to participate in an in-person EEG assessment.
• Able to use a smart phone, tablet, or computer independently to access email and webpages or have someone available in their home who can help them with initial session set-up and then leave for the treatment sessions.

You may not qualify if:

• Active suicidal ideation/intent indicating significant risk.
• Unstable medical or psychiatric condition (e.g., mania, psychotic symptoms) that would interfere with study participation.
• Behavioral issues noted in the record or observed during the screening process that would interfere with appropriate or safe videoconferencing treatment session participation or study procedures.
• Alcohol abuse (operationalized as scoring 15 or more if male or 13 or more if female on the Alcohol Use Disorders Identification Test), or any illicit drugs, all of which may impact EEG measures.
• Severe cognitive impairment defined as two or more errors on the Six-Item Screener.
• Having an EEG confounder (e.g., congenital or acquired skull defects, missing sections or holes in the skull, or plates, screws, or other implants within the skull or brain) that would interfere with reliable EEG data collection.
• Active cancer treatment or primary pain is due to cancer.

Sponsors & Collaborators

• University of Washington: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• VA Puget Sound Health Care System: collaborator

Study Sites (3)

University of Washington, Ninth and Jefferson Building

Seattle, Washington, 98104, United States

Location

VA Puget Sound Health Care System, Seattle Division

Seattle, Washington, 98108, United States

Location

VA Puget Sound Health Care System, American Lake

Tacoma, Washington, 98493, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Cognitive Behavioral Therapy; Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mindfulness

Study Officials

• Mark P Jensen, Ph.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

• Rhonda M Williams, Ph.D.

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Rehabilitation Medicine

Model Details: A randomized, 4-group parallel design, 264-subject clinical trial to identify predictive markers that determine who benefits most from two complementary and integrative health (CIH) treatments (Hypnotic Cognitive Therapy \[HYP-CT\] and Mindfulness-Based Cognitive Therapy \[MBCT\]) vs. the current gold standard non-pharmacological treatment (Cognitive Behavioral Therapy, or CBT) vs. usual care (UC). This aim will be addressed in the context of a clinical trial in which participants with chronic pain will be randomized to one of the three active chronic pain treatments or UC.

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 26, 2023
• Study Start: April 26, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data used for the analyses for any papers published will become available to interested researchers by request after that article is published. Those data will continue to be available for at least five years following the publication of the article.
• Access Criteria: The investigators will make the data and associated documentation available to users under a written agreement that adheres to any applicable Informed Consent provisions and prohibits the recipient from identifying or re-identifying any individual whose data are included in the dataset. The recipient will have sufficient knowledge, training, and resources to adequately design and conduct the studies replicating the original work, or can otherwise determine the validity of results by reviewing the data provided. Requests for data will be considered on a case by case basis through a formal application and review process. The minimal amount of data will be provided to address the specific request. Only limited, fully de-identified data will be shared.

Locations

US (3)