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

The University of Texas System (UT)

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Other: Health Education (active control); Other: mindfulness meditation(MM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05556057

HSC-MS-22-0035

1R34AT011530-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

Our multidisciplinary, interinstitutional team of investigators proposes to randomize 60 SCI patients experiencing chronic pain to practice audio-guided MM for ≥ 10 minutes daily for 6 weeks using the free app "Mindfulness Coach" developed by the Department of Veteran Affairs, or to listen or view health education presentations (active control) ≥ 10 minutes daily for 6 weeks on the free TED app (active control). Primary outcomes are the feasibility and acceptability of proposed interventions in people with SCI and chronic pain. Secondary outcomes include the feasibility of collecting patient-reported outcomes of pain, anxiety, depression, mindfulness, quality of life, stress, fatigue and sleep disturbance.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

65 participants in 2 patient groups

mindfulness meditation(MM)

Experimental group

Treatment:

Other: mindfulness meditation(MM)

Health Education

Active Comparator group

Treatment:

Other: Health Education (active control)