N/A N=60 Randomized Single-blind Other

Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury

Spinal Cord Injuries

Bottom Line

View on ClinicalTrials.gov: NCT05556057 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Aug 2025

Primary outcome: Primary: Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent — 65 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: mindfulness meditation(MM) (Other); Health Education (active control) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent	65	—
PRIMARY 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	15; 16	—
PRIMARY Feasibility as Assessed by the Number of Participants That Complete All Visits	18; 19	—
PRIMARY Acceptability Rate as Assessed by the Number of Participants Who Scored 20 or Greater on the Modified Client Satisfaction Questionnaire-8	18; 19	—
PRIMARY Feasibility as Assessed by the Number of Participants That Complete All Visits	18; 19	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Pain as Assessed by the Number of Participants Who Completed the International SCI Pain Basic Data Subset (Version 2)	18; 19; 22; 20	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Pain as Assessed by the Number of Participants Who Completed the International SCI Pain Basic Data Subset (Version 2)	18; 19; 22; 20	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Pain-related Distress as Assessed by the Number of Participants Who Completed the Chronic Pain Acceptance Questionnaire (CPAQ-R8)	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Pain-related Distress as Assessed by the Number of Participants Who Completed the Chronic Pain Acceptance Questionnaire (CPAQ-R8)	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Brief Pain as Assessed by the Number of Participants Who Completed the Brief Pain Catastrophizing Scale (Brief PCS)	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Brief Pain as Assessed by the Number of Participants Who Completed the Brief Pain Catastrophizing Scale (Brief PCS)	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Anxiety as Assessed by the Number of Participants Who Completed the General Anxiety Disorder-7 (GAD-7) Questionnaire	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Anxiety as Assessed by the Number of Participants Who Completed the General Anxiety Disorder-7 (GAD-7) Questionnaire	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8)	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8)	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Mindfulness as Assessed by the Number of Participants Who Completed the Five Facet Mindfulness Questionnaire-15 (FFMQ-15)	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Mindfulness as Assessed by the Number of Participants Who Completed the Five Facet Mindfulness Questionnaire-15 (FFMQ-15)	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Quality of Life as Assessed by the Number of Participants Who Completed the SCI-quality of Life (QOL): Positive Affect and Well Being-Short Form (PAWB-SF)	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Patient Reported Outcomes of Quality of Life as Assessed by the Number of Participants Who Completed the SCI-quality of Life (QOL): Positive Affect and Well Being-Short Form (PAWB-SF)	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4)	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4)	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a	20; 19; 23; 22	—
SECONDARY Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2)	23; 22	—
SECONDARY Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2)	23; 22	—
SECONDARY Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2)	23; 22	—
SECONDARY Feasibility of Collecting Sleep Disturbance as Assessed by the Number of Participants Who Completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance- Short Form 4a	23; 22	—
SECONDARY Feasibility of Collecting Sleep Disturbance as Assessed by the Number of Participants Who Completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance- Short Form 4a	23; 22	—
SECONDARY Feasibility of Collecting Sleep Disturbance as Assessed by the Number of Participants Who Completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance- Short Form 4a	23; 22	—

Summary

The purpose of this study is to evaluate the feasibility and acceptability of a 6-week app-guided Mindfulness meditation training (MM) intervention and health education (active control) condition in people with spinal cord injury (SCI) who have chronic pain and to examine the feasibility of data collection procedures

Eligibility Criteria

Inclusion Criteria

Traumatic SCI of at least 6 months duration
Chronic pain [defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale]
Understand spoken and written English sufficiently to provide informed consent
participate in the intervention and complete study surveys

Exclusion Criteria

Lack of daily access to the internet using a smart phone or smart tablet
Cognitive impairment (determined by their inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions pertaining to the study)
Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations or health education presentations on Ted-talk
Use of any kind of meditation more than once a week in the last 3 months
Inability to provide or obtain an email address for communication with study staff
Inability to operate the app download or study related survey using a smartphone.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05556057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.