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Behavioural Intervention

Psychological Therapies for Chronic Pain via Telehealth (GPTVTCOVCP Trial)

N/A

Recruiting

Led By Brandon C Yarns, MD MS BME

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 60-95 years

Have an average daily pain intensity of at least 4 on a 0 to 10 scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating the effectiveness of 3 psychological treatments for chronic pain among older US Veterans, delivered via telehealth. It's assessing the best treatment for them and how it works.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Psychological interventions like CBT, EAET, and MM may cause emotional discomfort or distress initially as individuals confront difficult emotions or thoughts related to their chronic pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 60 and 95 years old.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brief Pain Inventory: Mean Pain Severity

Secondary study objectives

Brief Pain Inventory: Pain Interference

Generalized Anxiety Disorder 7-item

PTSD Checklist for DSM-5

+2 more

Other study objectives

Chronic Pain Acceptance Questionnaire-2 Item

Coping Strategies Questionnaire

Emotional Approach Coping Scales

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness MeditationExperimental Treatment1 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 TherapyExperimental Treatment1 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 TherapyActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Emotional Awareness and Expression Therapy

2019

N/A

~260

Mindfulness Meditation

2015

Completed Phase 2

~4040