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Mindfulness Meditation for Spinal Cord Injury
N/A
Recruiting
Led By Chelsea Ratcliff, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study at 3 years
Awards & highlights
Study Summary
This trial looks at whether a six-week mindfulness meditation training intervention can help people with spinal cord injuries and chronic pain, and if data collection procedures are feasible.
Who is the study for?
This trial is for people with spinal cord injury (SCI) who have had it for at least 6 months and suffer from chronic pain, rating their pain intensity 4 or higher on a scale of 10. Participants must understand English well enough to consent and complete surveys. They can't join if they lack daily internet access, have significant cognitive impairments, visual/hearing issues preventing app use, practice meditation frequently, or can't provide an email.Check my eligibility
What is being tested?
The study tests the effectiveness of a mindfulness meditation training program delivered through an app over six weeks against health education as a control group in individuals with SCI experiencing chronic pain. The goal is to see how feasible and acceptable this intervention is and how well data collection works.See study design
What are the potential side effects?
Since the interventions involve mindfulness meditation and health education rather than medical treatments or drugs, there are no direct physical side effects expected. However, participants may experience emotional discomfort when confronting painful experiences during meditation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study at 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study at 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability as assessed by the patient-reported program evaluation questionnaire scale
Feasibility as assessed by the number of participants that complete all visits
Feasibility as assessed by the number of participants who complete the minimum recommended minutes (i.e., 60 minutes/per week) of using the MM or HE app during the 6 weeks intervention
+1 moreSecondary outcome measures
Feasibility of collecting fatigue as assessed by the PROMIS Fatigue- Short Form 4a
Feasibility of collecting patient reported outcomes of anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) questionnaire
Feasibility of collecting patient reported outcomes of brief pain as assessed by the Brief Pain Catastrophizing Scale (Brief PCS)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: mindfulness meditation(MM)Experimental Treatment1 Intervention
Group II: Health EducationActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Sam Houston State UniversityOTHER
4 Previous Clinical Trials
450 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,900 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,913 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a spinal cord injury for at least 6 months.I have been in pain for at least 3 months, and it's quite severe.I understand the study details after answering questions about it.I can take part in the study and fill out surveys.I cannot provide an email for study communication.I have practiced meditation regularly for the past 3 months.I have had pain for at least 3 months with a severity of 4 or more.
Research Study Groups:
This trial has the following groups:- Group 1: mindfulness meditation(MM)
- 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.
Have you been enrolling new volunteers for the trial recently?
"As is evident from clinicaltrials.gov, the recruitment period for this clinical trial has closed; it was first posted on December 1st 2022 and most recently updated October 15th 2022. Nevertheless, 903 other medical studies are currently recruiting patients."
Answered by AI
What is the expected result of this research initiative?
"This clinical trial seeks to determine the feasibility of their proposed intervention by measuring how many participants complete a minimum of 60 minutes per week on either MM or HE apps over 6 weeks. Secondary objectives include assessing pain-related distress via Chronic pain Acceptance Questionnaire (CPAQ-R8), Brief Pain Catastrophizing Scale, and PROMIS Fatigue Short Form 4a scores."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Colorado
What site did they apply to?
TIRR Memorial Hermann
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
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