Effects of a Mobile App-Based Mindfulness Intervention in Persons with Spinal Cord Injury and Chronic Pain

The University of Texas System (UT)

Status

Not yet enrolling

Conditions

Spinal Cord Injuries

Treatments

Other: Mindfulness meditation (MM) Intervention

Other: Health Education Active Control Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06891989

HSC-MS-25-0005

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of a 6-week app-guided MM intervention compared to a 6-week app-guided health education AC condition on pain intensity, pain interference, depression, and anxiety.

Enrollment

282 estimated 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 internet access
inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions about the study
Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations
Use of any meditation more than once a week in the last 3 months
Inability to provide or obtain an email address for registration to the AC intervention and/or communication with study staff
inability to provide a phone number for communication with study staff