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Behavioral Intervention
Mindfulness Therapy for Chronic Pain
N/A
Recruiting
Research Sponsored by Canandaigua VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18 years and older
English-speaking veterans
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months post-treatment follow-up
Awards & highlights
Study Summary
This trial will see if a mindfulness intervention can help reduce pain and suicide risk in people with chronic pain.
Who is the study for?
This trial is for English-speaking veterans, aged 18 or older, who understand the study and have chronic pain affecting their daily life. They must also be at risk of suicide, either having suicidal thoughts recently, a history of such ideation in the past few months, or an attempt within the last six months.Check my eligibility
What is being tested?
The study is testing Mindfulness-Based Cognitive Therapy (MBCT) to see if it helps reduce problems caused by chronic pain and lowers suicide risk compared to standard Health Education.See study design
What are the potential side effects?
Mindfulness interventions are generally considered safe but may sometimes lead to discomfort when confronting difficult emotions or memories. Health education has no known side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am a veteran and I speak English.
Select...
I have experienced pain on most days for the last six months or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months post-treatment follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months post-treatment follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Depression
Interpersonal Needs
Pain Interference and intensity
+2 moreSecondary outcome measures
Fear of pain
Health-related Quality of Life
Mindfulness
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Cognitive Therapy (MBCT)Experimental Treatment1 Intervention
MBCT delivered over the course of 10, ~60 minute sessions
Group II: Health EducationActive Control1 Intervention
Health education sessions delivered over the course of 10, ~60 minute sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Cognitive Therapy (MBCT)
2014
N/A
~180
Find a Location
Who is running the clinical trial?
Canandaigua VA Medical CenterLead Sponsor
12 Previous Clinical Trials
1,770 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,897 Total Patients Enrolled
45 Trials studying Chronic Pain
17,933 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have surgeries planned.You need to have a high level of pain based on a short questionnaire.I am a veteran and I speak English.Veterans must report having thoughts of being better off dead or thoughts of hurting themselves, or report having thoughts of death in the last 3 months, or report a suicide attempt in the last 6 months.I do not have any uncontrolled medical conditions.You have plans to harm yourself.You have been diagnosed with schizophrenia, experiencing active psychosis, or mania.You currently have a serious problem with using drugs or alcohol.I have experienced pain on most days for the last six months or more.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness-Based Cognitive Therapy (MBCT)
- Group 2: Health Education
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What end result is being sought by this experiment?
"This trial aims to assess the treatment acceptability of patients over a 6 month period post-treatment. The secondary outcomes include Pain catastrophizing, as measured by the Pain Catastrophizing Scale (PCS). This is a 13 item scale with each answer graded on a 5 point rating system. Additionally, this study seeks to evaluate patient's acceptance of pain using the Chronic pain Acceptance Questionnaire (CPAQ) and Quality of Life through Veterans Rand 12 question survey which produces both Physical Component Score (PCS) and Mental Component Score (MCS)."
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