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

NCT06891989 | Not Yet Recruiting

• 1 other identifier: HSC-MS-25-0005
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain intensity in people with spinal cord injury (PwSCI) as assessed by Numeric Rating Scale (NRS).

  Pain will be measured on Numeric Rating Scale (NRS) from 0(no pain) to 10(pain as bad as you can imagine)

  baseline , post-intervention (6 weeks after baseline)

Secondary Outcomes (3)

• Change in pain interference as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference scale

  baseline , post-intervention (6 weeks after baseline)

• Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)

  baseline , post-intervention (6 weeks after baseline)

• Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD-7)

  baseline , post-intervention (6 weeks after baseline)

Study Arms (2)

Mindfulness meditation (MM)

EXPERIMENTAL

Other: Mindfulness meditation (MM) Intervention

Active Control (AC)

ACTIVE COMPARATOR

Other: Health Education Active Control Intervention

Interventions

Mindfulness meditation (MM) Intervention 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.

Mindfulness meditation (MM)

Health Education Active Control Intervention 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.

Active Control (AC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Mindfulness; Methods

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Investigative Techniques

Study Officials

• Radha Korupolu, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radha Korupolu, MD

CONTACT

713-797-5233; Radha.Korupolu@uth.tmc.edu

Shrasti Lohiya

CONTACT

713-797-7132; Shrasti.Lohiya@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)