Psychological Therapies for Chronic Pain via Telehealth

(GPTVTCOVCP Trial)

Recruiting at 1 trial location

Overseen By Brandon C Yarns, MD MS BME

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

Trial Summary

How is the treatment 'Psychological Therapies for Chronic Pain via Telehealth' unique compared to other treatments for chronic pain?

This treatment is unique because it combines various psychological therapies like Cognitive Behavioral Therapy and Emotional Awareness and Expression Therapy, delivered via telehealth, which can make it more accessible and convenient for patients compared to traditional face-to-face sessions. ¹

What is the purpose of this trial?

This study is being performed to compare the effects of three types of group-based psychological treatments delivered over video telehealth for chronic musculoskeletal pain in older U.S. military Veterans. The three types of psychological treatments are: Cognitive-Behavioral Therapy (CBT), Emotional Awareness and Expression Therapy (EAET), and Mindfulness Meditation (MM). In addition, the investigators will evaluate which patients respond best to each treatment and how each treatment works. The investigators are performing the study because chronic pain is a big problem among Veterans. Older Veterans are the focus because they have the highest rates of chronic pain, perhaps as high has 80%. The investigators are looking at psychological treatments because they are less risky than medications or procedures for older Veterans. Telehealth is an important aspect of the proposal, as delivery over telehealth could improve access to treatments. CBT is endorsed nationally by VA, but no standardized MM is available through VA, and only a few VA sites use EAET, which is a newer treatment focusing on how stress and emotions affect pain. The project aims to evaluate a standardized form of MM and the newer treatment, EAET, compared to the standard CBT used widely in VA.

Research Team

Brandon C Yarns, MD MS BME

Principal Investigator

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

Eligibility Criteria

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.

Criterion: People who have served in the military.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Ireland 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. [2020]