Psychological Therapies for Chronic Pain via Telehealth

(GPTVTCOVCP Trial)

Recruiting at 1 trial location

Overseen By Karin C Liu, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Severe psychiatric disorder, Active substance use, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how three psychological treatments reduce chronic pain in older Veterans. The treatments include Cognitive Behavioral Therapy (CBT), which teaches pain management skills; Emotional Awareness and Expression Therapy (EAET), which focuses on emotions and stress; and Mindfulness Meditation (MM), which encourages present-moment awareness. Delivered via telehealth, the study provides easy access for Veterans from home. Veterans aged 60-95 with musculoskeletal pain (pain in muscles, bones, or joints) for at least three months might be suitable candidates. As an unphased trial, it offers Veterans the chance to explore innovative treatments conveniently from home.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on psychological treatments, which are generally less risky than medications, but it's best to discuss your specific situation with the trial coordinators.

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

A previous study showed that Cognitive Behavioral Therapy (CBT) is safe and well-tolerated. It helps individuals manage symptoms by changing negative thoughts and behaviors. Research indicates that CBT effectively treats chronic pain, depression, and anxiety without significant risks.

For Emotional Awareness and Expression Therapy (EAET), research suggests it is generally safe and helps individuals address emotional conflicts that may cause pain. Although newer than other therapies, studies suggest positive results with few side effects.

Mindfulness Meditation is another option. Studies have shown it to be low-risk, with potential benefits for reducing stress and managing chronic pain. It involves practices like mindful breathing and meditation, which are considered safe for most people.

Overall, these psychological treatments pose less risk compared to medications or surgery, especially for older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these psychological therapies for chronic pain because they offer innovative, non-pharmacological approaches that can be accessed via telehealth, making them more accessible to those who may not have easy access to traditional in-person therapy. Cognitive Behavioral Therapy (CBT) focuses on teaching practical skills to manage symptoms, such as relaxation and changing negative thought patterns, which differs from medication-based treatments that primarily target the physical aspects of pain. Emotional Awareness and Expression Therapy (EAET) is unique in its approach to addressing emotional conflicts and expression, aiming to reduce both physical pain and emotional distress, unlike conventional treatments that may not address these emotional components. Mindfulness Meditation emphasizes achieving present moment awareness and self-compassion, offering a holistic approach that fosters acceptance and mental resilience, contrasting with the often symptom-focused standard treatments.

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

Research has shown that Cognitive Behavioral Therapy (CBT), one of the treatments in this trial, helps individuals with chronic pain by altering negative thoughts and behaviors, which can significantly improve symptoms. Emotional Awareness and Expression Therapy (EAET), another treatment option in this trial, might reduce pain even more than CBT. Specifically, some trials found that 63% of participants using EAET experienced significant pain relief. Mindfulness Meditation (MM), also under study in this trial, is associated with a small decrease in pain and aids in stress management by encouraging focus on the present moment. Each of these treatments reduces pain in different ways, offering options that might suit different individuals better. ^{1 2 6 7 8}

Who Is on the Research Team?

Brandon C Yarns, MD MS BME

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Are You a Good Fit for This Trial?

This trial is for U.S. military Veterans aged 60-95 with chronic musculoskeletal pain, such as back or neck pain, lasting at least 3 months and causing moderate to severe daily discomfort. Participants must be able to use video telehealth services and speak English fluently.

Inclusion Criteria

I have had muscle or joint pain, including back, neck, or headaches, for at least 3 months.

I am between 60 and 95 years old.

My daily pain level averages at least 4 out of 10.

Exclusion Criteria

You have a severe mental health condition that is not controlled with medication, a high risk of suicide or violence, a severe problem with alcohol or drugs, major problems with memory and thinking, have previously completed certain pain treatments, are currently receiving another type of psychological pain treatment, are involved in legal matters related to pain, have difficulty reading or speaking English, or do not have internet at home.

My main health issue is pain from conditions like arthritis or carpal tunnel.

I have a condition like rheumatoid arthritis, cancer pain, or sickle cell disease that causes chronic pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive group-based psychological treatments (CBT, EAET, MM) delivered over video telehealth for chronic musculoskeletal pain

20 weeks

Weekly sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy
• Emotional Awareness and Expression Therapy
• Mindfulness Meditation

Trial Overview

The study compares three psychological treatments delivered via video conference: Cognitive-Behavioral Therapy (CBT), Emotional Awareness and Expression Therapy (EAET), and Mindfulness Meditation (MM). It aims to determine which treatment works best for older Veterans with chronic pain.

How Is the Trial Designed?

Group I: Mindfulness Meditation Experimental Treatment 1 Intervention

Seeks to help individuals achieve present moment awareness, self-compassion, and acceptance of chronic pain. It will use techniques such as the body scan, grounding, mindful breathing, mindful walking, loving kindness, and compassionate breathing.

Group II: Emotional Awareness and Expression Therapy Experimental Treatment 1 Intervention

Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.

Group III: Cognitive Behavioral Therapy Active Control 1 Intervention

Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.

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

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

This systematic review and network meta-analysis will evaluate the effectiveness of various psychotherapies, both online and in-person, for managing chronic pain, addressing a significant gap in current research.

The study aims to rank these psychotherapies based on their ability to reduce pain interference and psychological distress, providing valuable insights for clinicians and guiding future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An analysis of psychotherapies delivered online and in person for patients with chronic pain: protocol for a systematic review and network meta-analysis. Haugh, S., O'Connor, L., Slattery, B., et al.[2020]

Citations

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Behavioral Therapy - StatPearls - NCBI Bookshelf - NIH

Behavioral therapy is a practical approach to modifying behavior using techniques such as reinforcement, enhanced communication, shaping, and modeling.

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sciencedirect.com

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frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1200685/full

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mirecc.va.gov

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A Provider's Guide to Brief Cognitive Behavioral Therapy

CBT combines cognitive and behavioral therapies and has strong empirical support for treating mood, sleep, chronic pain, and anxiety disorders (Hoffman & Otto, ...

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en.wikipedia.org/wiki/Cognitive_behavioral_therapy

Cognitive behavioral therapy

Cognitive behavioral therapy (CBT) is a form of psychotherapy that aims to reduce symptoms of various mental health conditions, primarily depression, ...

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healthline.com

healthline.com/health/cognitive-behavioral-therapy

Cognitive Behavioral Therapy: Techniques, Types, and Uses

Cognitive behavioral therapy (CBT) is a treatment approach that helps you recognize negative or unhelpful thought and behavior patterns. CBT ...