Psychosocial Therapies for Chronic Pain

(MATCH Trial)

Not currently recruiting at 2 trial locations

Overseen By Sydney Drever, B.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Suicidal ideation, Unstable condition, Alcohol abuse, Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different therapies to manage chronic pain, focusing on veterans who don't find relief with standard treatments. It compares Cognitive Behavioral Therapy (CBT) with newer approaches like Hypnotic Cognitive Therapy (HYP-CT) and Mindfulness-Based Cognitive Therapy (MBCT) to determine which works best based on individual factors. The goal is to match patients with the treatment most likely to help them, tailoring care to their specific needs. Veterans who have experienced chronic pain most days for at least three months and are open to trying new methods via videoconferencing may find this trial beneficial. As an unphased trial, this study offers a unique opportunity to explore innovative therapies that could significantly improve quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Hypnotic Cognitive Therapy (HYP-CT) is generally easy for people to handle. Studies have found that those using HYP-CT for long-term pain often feel less pain for up to a year after treatment. Early findings also suggest it can quickly relieve pain for some people.

Mindfulness-Based Cognitive Therapy (MBCT) is also considered safe. A review of studies found that MBCT might be a good option for treating long-term pain. Participants in these studies safely experienced less pain and better overall function.

Cognitive Behavioral Therapy (CBT) is a well-known and safe treatment for long-term pain. It has been widely used and has effectively reduced pain and improved daily life. Research supports its safety in treating both mental and physical health issues related to long-term pain.

Overall, these therapies are considered safe and can significantly reduce pain for many people. However, as with any treatment, results can vary from person to person. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these therapies for chronic pain because they offer unique approaches that go beyond typical pain medications. Hypnotic Cognitive Therapy (HYP-CT) stands out by using hypnosis to help patients focus their attention and accept new positive ideas about pain, potentially improving comfort and well-being. Mindfulness-Based Cognitive Therapy (MBCT) trains the mind to respond more adaptively to pain and its related issues, like sleep problems and stress, by fostering a non-judgmental awareness of experiences. Cognitive Behavioral Therapy (CBT) helps reshape negative thoughts about pain and encourages positive coping strategies, such as relaxation and goal setting, providing a comprehensive toolset for managing pain. Each therapy provides a fresh, non-pharmacological avenue to tackle chronic pain, emphasizing mental and behavioral adaptation.

What evidence suggests that this trial's treatments could be effective for chronic pain?

This trial will compare the effectiveness of three treatments for chronic pain: Cognitive Behavioral Therapy (CBT), Hypnotic Cognitive Therapy (HYP-CT), and Mindfulness-Based Cognitive Therapy (MBCT). Studies have shown that all three treatments can help reduce chronic pain. Participants in this trial may receive CBT, which helps manage pain, though its effects are usually small to moderate. Others may receive HYP-CT, which research indicates can lead to medium to large improvements in pain levels, with some studies showing benefits lasting up to 12 months. Participants may also be assigned to MBCT, which effectively reduces chronic pain symptoms and can significantly improve pain control. Early findings suggest that matching patients to the treatment that best fits their needs might lead to even greater pain relief. ^{5 6 7 8 9}

Who Is on the Research Team?

Mark P Jensen, Ph.D.

Principal Investigator

University of Washington

Rhonda M Williams, Ph.D.

Principal Investigator

VA Puget Sound Health Care System

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Mindfulness-Based Cognitive Therapy (MBCT) condition Experimental Treatment 1 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) condition Experimental Treatment 1 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 condition Active Control 1 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) condition Active Control 1 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

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+

Published Research Related to This Trial

A study involving 278 patients with chronic back pain found that an AI-driven cognitive behavioral therapy for chronic pain (AI-CBT-CP) was noninferior to standard telephone CBT-CP, showing similar effectiveness in reducing disability and pain over 6 months.

AI-CBT-CP not only achieved better clinical outcomes for patients but also required less than half the therapist time compared to traditional CBT-CP, suggesting it could improve access to treatment for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Piette, JD., Newman, S., Krein, SL., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of a Group Hypnosis Protocol for Managing Chronic Pain in Outpatient Integrative Medicine. McKernan, LC., Finn, MTM., Crofford, LJ., et al.[2023]

A survey of 152 physical therapists revealed that while only a minority currently use cognitive-behavioral therapy (CBT) techniques like activity pacing (81%) and pleasurable activity scheduling (30%) for treating older patients with chronic pain, there is a significant interest in incorporating these methods into practice.

Barriers to using CBT include a lack of knowledge and skills, concerns about reimbursement, and time constraints, indicating that addressing these issues could enhance the integration of CBT into physical therapy for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. Beissner, K., Henderson, CR., Papaleontiou, M., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current psychological approaches to the management of chronic pain. Molton, IR., Graham, C., Stoelb, BL., et al.[2018]

A study involving 14 patients with chronic pain explored their experiences with a high-intensity cognitive-behavioral therapy (CBT) protocol, which included various innovative techniques like tactile attention-shift training and video feedback.

Patients reported varying levels of helpfulness from different CBT components, with memory work being beneficial for nine patients and visual feedback being very helpful for six, indicating that personalized approaches in CBT may enhance treatment outcomes for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention and Imagery in Cognitive-Behavioral Therapy for Chronic Pain: An Exploratory Study. Kutsuzawa, K., Taguchi, K., Shimizu, E.[2022]

Cognitive hypnotherapy has been shown to be an effective intervention for managing various types of chronic pain, including conditions like fibromyalgia and osteoarthritis, based on evidence from randomized controlled trials.

The review highlights the growing support for hypnosis and cognitive-behavioral techniques in pain management, suggesting they could be valuable tools in clinical practice for treating patients with chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive hypnotherapy for pain management. Elkins, G., Johnson, A., Fisher, W.[2018]

The pilot study involving 53 patients with spinal cord injury (SCI) demonstrated that hypnosis-enhanced cognitive therapy (HYP-CT) is feasible in an inpatient rehabilitation setting, with 71% of participants completing at least 3 sessions and reporting satisfaction without any adverse events.

Exploratory analyses indicated that HYP-CT led to significant reductions in pain levels and improvements in self-efficacy and pain acceptance, suggesting it may be an effective nonpharmacologic intervention for managing SCI-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Brief, Hypnotic Enhanced Cognitive Therapy for SCI-related Pain During Inpatient Rehabilitation. Starosta, AJ., Bombardier, CH., Kahlia, F., et al.[2023]

A multidisciplinary pain management program based on cognitive behavioral therapy (CBT) significantly improved health-related quality of life (HRQL) and reduced pain intensity in 113 participants over an 8-week period.

The program also enhanced participants' readiness to change their approach to managing chronic pain, suggesting it can effectively break the cycle of chronic pain by addressing psychosocial factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Dysvik, E., Kvaløy, JT., Stokkeland, R., et al.[2022]

Cognitive and behavioral techniques (CBT) are effective in managing chronic pain by addressing not just physical symptoms but also the psychosocial factors that influence pain and disability.

CBT focuses on improving quality of life through psychoeducation and activity-centered approaches, helping patients identify meaningful and realistic activities to cope with their current situation rather than trying to return to their previous level of functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Why propose cognitive-behavioural therapy for chronic pain patients ?] Souche, A., Piguet, V., Desmeules, J., et al.[2019]

Cognitive hypnotherapy (CH) is an integrative treatment that combines hypnotherapy with cognitive-behavior therapy, providing a structured approach to managing emotional disorders.

This method meets the criteria for an assimilative model of integrative psychotherapy, suggesting it effectively incorporates both theoretical and empirical evidence in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Hypnotherapy as a Transdiagnostic Protocol for Emotional Disorders. Alladin, A., Amundson, J.[2018]

A meta-analysis of 48 studies involving 1,928 participants found that cognitive-behavioral therapy enhanced with hypnosis (CBTH) provides a small to medium significant advantage over standard cognitive-behavioral therapy (CBT) in treating conditions like depression and pain.

At follow-up, CBTH showed a medium-sized advantage, particularly effective for obesity treatment, suggesting that hypnosis can enhance the long-term efficacy of CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Hypnosis as an Adjunct to Cognitive Behavior Therapy: An Updated Meta-Analysis. Ramondo, N., Gignac, GE., Pestell, CF., et al.[2021]

Patients with complex chronic pain conditions benefit from psychosocial interventions alongside traditional pain relief methods, as analgesia alone is often insufficient.

Cognitive behavioral therapy techniques, including psychoeducation, mindfulness, and relaxation exercises, are effective in helping patients manage their pain and improve daily functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychosocial treatment of pain at general practitioners and in specialist pain treatment units]. Handberg, G.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Ehde, DM., Dillworth, TM., Turner, JA.[2022]

Citations

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