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Completed

NCT Number: NCT05556057

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

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

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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

TIRR Memorial Hermann, Houston, Texas, United States

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About this study

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.

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 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.

Treatment and study plan

mindfulness meditation(MM)

Other

Participants will be provided with a unique invitation code that will allow them to download and use the free research version of the Mindfulness Coach app that is designed to deliver mindfulness training developed by the Veteran Affairs' National Center for PTSD.The app is tailored to users who may be skeptical about meditation practices by providing simple instructions and brief meditation exercises. The app offers written information about mindfulness as well as 12 audio-guided meditations each lasting 8-13 minutes, with an average length of 10 minutes

Health Education (active control)

Other

Participants will be asked to download and use the free TED Talk app.Each participant's account will include a list of over 80 TED Talks related to the six broad categories of sleep, nutrition, mood, relationships, chronic pain, and health behaviors. These talks range from 4 to 18 minutes and were reviewed/selected by the investigator team. The research coordinator(RC) will instruct them to watch or listen to these videos for ≥ 10 minutes daily for 6 days per week. The RC will ask participants to complete weekly logs of their TED Talk app use

Primary outcomes

  1. Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent

    Time frame: end of study at 3 years

  2. Feasibility as Assessed by the Number of Participants Who Complete the Minimum Recommended Minutes (i.e., 60 Minutes/Per Week) of Using the MM or HE App During the 6 Weeks Intervention

    Time frame: post-intervention (6 weeks post-enrollment)

  3. Feasibility as Assessed by the Number of Participants That Complete All Visits

    Time frame: end of study (12 weeks post enrollment)

    Number of participants that complete all visits defined as participants who completed all study assessments, including baseline visits, immediate post-intervention assessments, and 12-week follow-up assessments.

  4. Acceptability Rate as Assessed by the Number of Participants Who Scored 20 or Greater on the Modified Client Satisfaction Questionnaire-8

    Time frame: post-intervention (6 weeks post-enrollment)

    The Client Satisfaction Questionnaire-8 measures satisfaction and the total score ranges from 8 to 32. The greater the score the higher satisfaction.

  5. Feasibility as Assessed by the Number of Participants That Complete All Visits

    Time frame: post-intervention (6 weeks post-enrollment)

    Number of participants that complete all visits defined as participants who completed all study assessments, including baseline visits and immediate post-intervention assessments.

Secondary outcomes

  1. Feasibility of Collecting Patient Reported Outcomes of Pain as Assessed by the Number of Participants Who Completed the International SCI Pain Basic Data Subset (Version 2)

    Time frame: Baseline

    This survey contains 11 questions and each one is measured from 0(no pain) to 10(chronic pain),with a maximum score of 110, a higher number indicating more pain

  2. Feasibility of Collecting Patient Reported Outcomes of Pain as Assessed by the Number of Participants Who Completed the International SCI Pain Basic Data Subset (Version 2)

    Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)

    This survey contains 11 questions and each one is measured from 0(no pain) to 10(chronic pain),with a maximum score of 110, a higher number indicating more pain

  3. Feasibility of Collecting Patient Reported Outcomes of Pain-related Distress as Assessed by the Number of Participants Who Completed the Chronic Pain Acceptance Questionnaire (CPAQ-R8)

    Time frame: baseline

    This is a 20 item questionnaire, each is scored from 0(never true) to 6(always true), a higher number indicating higher acceptance

  4. Feasibility of Collecting Patient Reported Outcomes of Pain-related Distress as Assessed by the Number of Participants Who Completed the Chronic Pain Acceptance Questionnaire (CPAQ-R8)

    Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)

    This is a 20 item questionnaire, each is scored from 0(never true) to 6(always true), a higher number indicating higher acceptance

  5. Feasibility of Collecting Patient Reported Outcomes of Brief Pain as Assessed by the Number of Participants Who Completed the Brief Pain Catastrophizing Scale (Brief PCS)

    Time frame: Baseline

    This measures three aspects of catastrophic cognitions about pain-rumination, magnification, and helplessness. This is a 13 item questionnaire. Each question has five response options ranging from 0 (not at all) to 4 (all the time) scale, with a maximum score of 52

  6. Feasibility of Collecting Patient Reported Outcomes of Brief Pain as Assessed by the Number of Participants Who Completed the Brief Pain Catastrophizing Scale (Brief PCS)

    Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)

    This measures three aspects of catastrophic cognitions about pain-rumination, magnification, and helplessness. This is a 13 item questionnaire. Each question has five response options ranging from 0 (not at all) to 4 (all the time) scale, with a maximum score of 52

  7. Feasibility of Collecting Patient Reported Outcomes of Anxiety as Assessed by the Number of Participants Who Completed the General Anxiety Disorder-7 (GAD-7) Questionnaire

    Time frame: Baseline

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

  8. Feasibility of Collecting Patient Reported Outcomes of Anxiety as Assessed by the Number of Participants Who Completed the General Anxiety Disorder-7 (GAD-7) Questionnaire

    Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)

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

  9. Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8)

    Time frame: Baseline

    This is an 8 item questionnaire.Each question is scored from 0 to 1 day = "not at all," 2 to 6 days = "several days," 7 to 11 days = "more than half the days," and 12 to 14 days = "nearly every day". Total score is determined by adding together the scores of each of the four items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).

  10. Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8)

    Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)

    This is an 8 item questionnaire.Each question is scored from 0 to 1 day = "not at all," 2 to 6 days = "several days," 7 to 11 days = "more than half the days," and 12 to 14 days = "nearly every day". Total score is determined by adding together the scores of each of the four items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).

  11. Feasibility of Collecting Patient Reported Outcomes of Mindfulness as Assessed by the Number of Participants Who Completed the Five Facet Mindfulness Questionnaire-15 (FFMQ-15)

    Time frame: Baseline

    This is a 15 item questionnaire, each is scored from 1(never or very rarely true) to 5(very often or always true) for a maximum score of 120, higher score indicating more mindfulness

  12. Feasibility of Collecting Patient Reported Outcomes of Mindfulness as Assessed by the Number of Participants Who Completed the Five Facet Mindfulness Questionnaire-15 (FFMQ-15)

    Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)

    This is a 15 item questionnaire, each is scored from 1(never or very rarely true) to 5(very often or always true) for a maximum score of 120, higher score indicating more mindfulness

  13. Feasibility of Collecting Patient Reported Outcomes of Quality of Life as Assessed by the Number of Participants Who Completed the SCI-quality of Life (QOL): Positive Affect and Well Being-Short Form (PAWB-SF)

    Time frame: Baseline

    This is a 10 item scale each scored from (1)never to (5)always, with a maximum score of 50 a higher number indicating a better outcome

  14. Feasibility of Collecting Patient Reported Outcomes of Quality of Life as Assessed by the Number of Participants Who Completed the SCI-quality of Life (QOL): Positive Affect and Well Being-Short Form (PAWB-SF)

    Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)

    This is a 10 item scale each scored from (1)never to (5)always, with a maximum score of 50 a higher number indicating a better outcome

  15. Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4)

    Time frame: Baseline

    The Perceived Stress Scale (PSS-4) is a four-item scale, each item is scored from 0(never) to 4(very often). The total score ranges from 0 to 16, a higher score indicating more stress

  16. Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4)

    Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)

    The Perceived Stress Scale (PSS-4) is a four-item scale, each item is scored from 0(never) to 4(very often). The total score ranges from 0 to 16, a higher score indicating more stress

  17. Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a

    Time frame: Baseline

    Each question has five response options ranging in value from five (very poor) to one (very good), a higher number indicating more fatigue.

  18. Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a

    Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)

    Each question has five response options ranging in value from five (very poor) to one (very good), a higher number indicating more fatigue.

  19. Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2)

    Time frame: Baseline

    This contains 7 items and answers are given on a 7-point scale ranging from 1 (never true) to 7 (always true). High scores on the AAQ-2 are reflective of greater experiential avoidance and immobility, while low scores reflect greater acceptance and action.

  20. Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2)

    Time frame: post-intervention (6 weeks post-enrollment)

    This contains 7 items and answers are given on a 7-point scale ranging from 1 (never true) to 7 (always true). High scores on the AAQ-2 are reflective of greater experiential avoidance and immobility, while low scores reflect greater acceptance and action.

  21. Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2)

    Time frame: end of study (12 weeks post enrollment)

    This contains 7 items and answers are given on a 7-point scale ranging from 1 (never true) to 7 (always true). High scores on the AAQ-2 are reflective of greater experiential avoidance and immobility, while low scores reflect greater acceptance and action.

  22. Feasibility of Collecting Sleep Disturbance as Assessed by the Number of Participants Who Completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance- Short Form 4a

    Time frame: Baseline

    This is a 4 item questionnaire and each question has five response options ranging in value from five (very poor) to one (very good) for a maximum score of 16, higher number indicating worse outcome.

  23. Feasibility of Collecting Sleep Disturbance as Assessed by the Number of Participants Who Completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance- Short Form 4a

    Time frame: post-intervention (6 weeks post-enrollment)

    This is a 4 item questionnaire and each question has five response options ranging in value from five (very poor) to one (very good) for a maximum score of 16, higher number indicating worse outcome.

  24. Feasibility of Collecting Sleep Disturbance as Assessed by the Number of Participants Who Completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance- Short Form 4a

    Time frame: end of study (12 weeks post enrollment)

    This is a 4 item questionnaire and each question has five response options ranging in value from five (very poor) to one (very good) for a maximum score of 16, higher number indicating worse outcome.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • Sam Houston State University
  • TIRR Memorial Hermann

Registry information

Official study title

Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury: A Pilot Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2022
Registry last updated
Aug 14, 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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