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NCT Number: NCT06891989

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: baseline , post-intervention (6 weeks after baseline)

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

Secondary outcomes

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

    Time frame: baseline , post-intervention (6 weeks after baseline)

    This is a 10 item questionnaire, each item is typically scored on a 5-point Likert scale from 1 (Not at all) to 5 (Very much), for a maximum raw score of 50, higher scores reflect greater pain interference.

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

    Time frame: baseline , post-intervention (6 weeks after baseline)

    This is a 8 item questionnaire , each measured on a 4 point scale from 0(not at all) to 3(nearly every day), for a score range of 0-27, higher score indicating worse outcome

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

    Time frame: baseline , post-intervention (6 weeks after baseline)

    This is an 7 item questionnaire, each is scored from 0(not at all) to 3(nearly every day), for a maximum score of 21, a higher score indicating more anxiety

Study contacts

Contact information is provided by the study sponsor or research team.

Radha Korupolu, MD

CONTACT

[email protected]

713-797-5233

Shrasti Lohiya

CONTACT

[email protected]

713-797-7132

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 24, 2025
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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