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Compassion Meditation for Chronic Pain

Phase 2
Recruiting
Led By Anne L Malaktaris
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
Pain most days (> 3 days/week) for at least 6 months
pain most days (> 3 days/week) for at least 6 months
Must not have
Concurrent enrollment in any other treatment specifically targeting chronic pain, anxiety, depression, or PTSD symptoms or social functioning (e.g., couples therapy) or any meditative or mind-body intervention (e.g., mindfulness, yoga)
Cognitive impairment that would interfere with treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 3-month follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate a novel intervention, compassion meditation, to address the challenges of chronic pain and psychological comorbidity among veterans.

Who is the study for?
This trial is for Veterans aged 18 or older with chronic pain most days and a probable diagnosis of depression or PTSD. They must be able to consent and not currently enrolled in other treatments targeting their conditions or mind-body interventions. Excluded are those with recent serious suicidality, untreated substance issues, unstable mental disorders, or cognitive impairments.
What is being tested?
The study compares Compassion Meditation (CM), which focuses on alleviating suffering, against Health Education for managing chronic pain and psychological comorbidities like PTSD and depression among Veterans. The efficacy of CM will be measured against the control group receiving standard health education.
What are the potential side effects?
While traditional side effects associated with medications may not apply here, participants might experience emotional discomfort during meditation practices or when discussing painful experiences during health education sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have experienced pain on most days for at least 6 months.
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I have experienced pain on most days for at least 6 months.
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I am 18 years old or older.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently enrolled in any treatments for chronic pain, mental health issues, or mind-body interventions.
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I do not have any mental health issues that would affect my treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 3-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 3-month follow-up 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 (BPI) Pain Interference subscale
Clinical Global Impression scale (CGI)
Secondary study objectives
Satisfaction with Life Scale (SWLS)
Veterans SF-36

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: compassion meditationExperimental Treatment1 Intervention
10 week, group-based manualized compassion meditation training
Group II: health educationActive Control1 Intervention
10 week, group-based manualized health education protocol

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,641 Total Patients Enrolled
42 Trials studying Chronic Pain
5,030 Patients Enrolled for Chronic Pain
Anne L MalaktarisPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA

Media Library

Compassion Meditation Clinical Trial Eligibility Overview. Trial Name: NCT04651296 — Phase 2
Chronic Pain Research Study Groups: compassion meditation, health education
Chronic Pain Clinical Trial 2023: Compassion Meditation Highlights & Side Effects. Trial Name: NCT04651296 — Phase 2
Compassion Meditation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04651296 — Phase 2
~30 spots leftby Aug 2025
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