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

NCT ID: NCT06891989

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2029-12-30

Brief Summary

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mindfulness meditation (MM)

Group Type: EXPERIMENTAL

Mindfulness meditation (MM) Intervention

Intervention Type: OTHER

Participants will be asked to download the Mindfulness Coach app that provides simple instructions and brief meditation exercises.This is a a gradual training program of 14 levels which will be completed in the first 2-3 weeks. Each level provides short readings about mindfulness and one or two guided meditations (a silent "seated practice" for increasing lengths of time plus typically an additional 8-13-minute meditation). As participants progress through the levels, they earn "badges" displayed in the app, and an image of a tree on the home screen grows as each successive level is completed.For the remaining weeks of the intervention, participants will select at least one (and ideally two) guided meditation per day from the complete list of available meditations.Participants will track their progress through weekly logs.

Active Control (AC)

Group Type: ACTIVE_COMPARATOR

Health Education Active Control Intervention

Intervention Type: OTHER

Participants will be asked to download and use the free TED Talk app, which will have 50 TED talk videos related to health that range from 3-20 minutes. Participants will be asked to watch or listen to these videos for ≥ 10 minutes daily for 6 days per week and complete weekly logs of the TED Talk app use.

Interventions

Mindfulness meditation (MM) Intervention

Participants will be asked to download the Mindfulness Coach app that provides simple instructions and brief meditation exercises.This is a a gradual training program of 14 levels which will be completed in the first 2-3 weeks. Each level provides short readings about mindfulness and one or two guided meditations (a silent "seated practice" for increasing lengths of time plus typically an additional 8-13-minute meditation). As participants progress through the levels, they earn "badges" displayed in the app, and an image of a tree on the home screen grows as each successive level is completed.For the remaining weeks of the intervention, participants will select at least one (and ideally two) guided meditation per day from the complete list of available meditations.Participants will track their progress through weekly logs.

Intervention Type: OTHER

Health Education Active Control Intervention

Participants will be asked to download and use the free TED Talk app, which will have 50 TED talk videos related to health that range from 3-20 minutes. Participants will be asked to watch or listen to these videos for ≥ 10 minutes daily for 6 days per week and complete weekly logs of the TED Talk app use.

Intervention Type: OTHER

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Radha Korupolu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Radha Korupolu, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Central Contacts

Radha Korupolu, MD

Role: CONTACT

Radha.Korupolu@uth.tmc.edu

713-797-5233

Shrasti Lohiya

Role: CONTACT

Shrasti.Lohiya@uth.tmc.edu

713-797-7132

Facility Contacts

Radha Korupolu, MD

Role: primary

Radha.Korupolu@uth.tmc.edu

713-797-5233

Shrasti Lohiya

Role: backup

Shrasti.Lohiya@uth.tmc.edu

713-797-7132

Other Identifiers

HSC-MS-25-0005

Identifier Type: -

Identifier Source: org_study_id