330 Participants Needed

Psychosocial Therapies for Chronic Pain

(MATCH Trial)

Recruiting at 2 trial locations
SD
JC
JC
SD
Overseen BySydney Drever, B.A.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy (CBT), Hypnotic Cognitive Therapy (HYP-CT), and Mindfulness-Based Cognitive Therapy (MBCT) for chronic pain?

Research shows that Cognitive Behavioral Therapy (CBT) is a well-established treatment for chronic pain, with multiple studies demonstrating its effectiveness in reducing pain and improving related issues. Hypnotic Cognitive Therapy (HYP-CT) has shown promise in managing chronic pain, particularly in group settings, with improvements in pain intensity and interference. Mindfulness-Based Cognitive Therapy (MBCT) is not directly mentioned, but similar therapies have been beneficial for chronic pain management.12345

Is psychosocial therapy for chronic pain safe for humans?

Cognitive behavioral therapy for chronic pain (CBT-CP) is considered safe and is an effective alternative to pain medications like opioids.678910

How does the treatment of Cognitive Behavioral Therapy (CBT), Hypnotic Cognitive Therapy (HYP-CT), and Mindfulness-Based Cognitive Therapy (MBCT) for chronic pain differ from other treatments?

This treatment is unique because it focuses on changing the way patients think about and respond to pain, rather than just addressing physical symptoms. It combines techniques like mindfulness, hypnosis, and cognitive restructuring to help patients manage pain by improving their mental and emotional well-being, which is different from treatments that rely solely on medication.29111213

What is the purpose of this trial?

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.

Research Team

MP

Mark P Jensen, Ph.D.

Principal Investigator

University of Washington

RM

Rhonda M Williams, Ph.D.

Principal Investigator

VA Puget Sound Health Care System

Eligibility Criteria

Adults over 18 with chronic pain, defined as having an average pain intensity of ≥3 on a scale of 0-10 for at least three months. Participants must speak English, have internet access for videoconferencing sessions, and be willing to avoid other clinical trials during the study. They should also be able to attend an in-person EEG assessment and use digital devices for communication.

Inclusion Criteria

I agree not to join any other studies for chronic pain while in this trial.
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
Willingness to be randomized to condition and use videoconferencing for treatment sessions
See 4 more

Exclusion Criteria

You have behaviors that might make it difficult or unsafe for you to participate in video treatment sessions or study procedures.
You drink too much alcohol or use illegal drugs, which could affect the study's measurements of brain activity.
You have trouble remembering things and understanding information, based on a specific test.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive one of the three active treatments (HYP-CT, MBCT, CBT) or usual care for chronic pain management

8 weeks
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Assessments at 3 and 6 months post-treatment

Open-label extension (optional)

Participants may opt into receiving any of the three treatments after the final 6-month follow-up assessment

Treatment Details

Interventions

  • Cognitive Behavioral Therapy (CBT)
  • Hypnotic Cognitive Therapy (HYP-CT)
  • Mindfulness-Based Cognitive Therapy (MBCT)
Trial Overview The MATCH Study is testing whether Hypnotic Cognitive Therapy (HYP-CT), Mindfulness-Based Cognitive Therapy (MBCT), or Cognitive Behavioral Therapy (CBT) are effective treatments for chronic pain. It aims to identify which therapy works best based on individual patient factors like brain activity and personality traits.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Cognitive Therapy (MBCT) conditionExperimental Treatment1 Intervention
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.
Group II: Hypnotic Cognitive Therapy (HYP-CT) conditionExperimental Treatment1 Intervention
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.
Group III: Usual Care (UC) Control Group conditionActive Control1 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.
Group IV: Cognitive Behavioral Therapy (CBT) conditionActive Control1 Intervention
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.

Cognitive Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Cognitive Behavioral Therapy for:
  • Chronic pain
  • Anxiety disorders
  • Depressive disorders
  • Trauma-related disorders
🇪🇺
Approved in European Union as Cognitive Behavioural Therapy for:
  • Chronic pain
  • Anxiety disorders
  • Depressive disorders
  • Trauma-related disorders
🇨🇦
Approved in Canada as Cognitive Behavioral Therapy for:
  • Chronic pain
  • Anxiety disorders
  • Depressive disorders
  • Trauma-related disorders

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

VA Puget Sound Health Care System

Collaborator

Trials
67
Recruited
225,000+

Findings from Research

Cognitive-behavioral therapy (CBT) is an effective first-line treatment for chronic pain, supported by numerous randomized controlled trials showing improvements in pain and related issues across various chronic pain syndromes.
Recent innovations in CBT delivery, such as web-based and telephone formats, have expanded its accessibility and effectiveness for diverse populations, including children and older adults, indicating a promising direction for future treatment approaches.
Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research.Ehde, DM., Dillworth, TM., Turner, JA.[2022]
Cognitive-behavioral therapy (CBT) and operant behavioral therapy are effective adjunctive treatments for chronic pain, with recent studies highlighting their role in addressing pain-related fears and adapting to specific patient groups.
Self-hypnosis training can provide temporary pain relief for many individuals with chronic pain, with some experiencing significant long-term reductions in pain, although its effectiveness is comparable to other relaxation techniques.
Current psychological approaches to the management of chronic pain.Molton, IR., Graham, C., Stoelb, BL., et al.[2018]
An 8-week group hypnosis treatment for 85 adults with chronic pain led to significant reductions in pain intensity and interference, with improvements maintained for up to 6 months after treatment.
The study suggests that group hypnosis can effectively teach individuals skills for managing chronic pain, indicating a promising alternative to individual hypnosis, though further research with larger trials is needed.
Delivery of a Group Hypnosis Protocol for Managing Chronic Pain in Outpatient Integrative Medicine.McKernan, LC., Finn, MTM., Crofford, LJ., et al.[2023]

References

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. [2022]
Current psychological approaches to the management of chronic pain. [2018]
Delivery of a Group Hypnosis Protocol for Managing Chronic Pain in Outpatient Integrative Medicine. [2023]
Feasibility of Brief, Hypnotic Enhanced Cognitive Therapy for SCI-related Pain During Inpatient Rehabilitation. [2023]
Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. [2021]
Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. [2023]
Cognitive Hypnotherapy as a Transdiagnostic Protocol for Emotional Disorders. [2018]
Clinical Hypnosis as an Adjunct to Cognitive Behavior Therapy: An Updated Meta-Analysis. [2021]
Attention and Imagery in Cognitive-Behavioral Therapy for Chronic Pain: An Exploratory Study. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Cognitive hypnotherapy for pain management. [2018]
[Why propose cognitive-behavioural therapy for chronic pain patients ?] [2019]
The effectiveness of a multidisciplinary pain management programme managing chronic pain on pain perceptions, health-related quality of life and stages of change--A non-randomized controlled study. [2022]
[Psychosocial treatment of pain at general practitioners and in specialist pain treatment units]. [2018]
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