Spinal Cord InjuriesNCT05556057
Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury
A study testing mindfulness meditation(MM) in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- mindfulness meditation(MM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Dec 2022to 16 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
TIRR Memorial Hermann
Houston, Texas, 77030
About this study
Official title: Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury: A Pilot Study
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
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- mindfulness meditation(MM), Health Education (active control)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| mindfulness meditation(MM) | Experimental | Not described Receives: Other: mindfulness meditation(MM) |
| Health Education | Active comparator | Not described Receives: Other: Health Education (active control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent
Measured: end of study at 3 years
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
Measured: post-intervention (6 weeks post-enrollment)
Feasibility as Assessed by the Number of Participants That Complete All Visits
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.
Measured: end of study (12 weeks post enrollment)
Acceptability Rate as Assessed by the Number of Participants Who Scored 20 or Greater on the Modified Client Satisfaction Questionnaire-8
The Client Satisfaction Questionnaire-8 measures satisfaction and the total score ranges from 8 to 32. The greater the score the higher satisfaction.
Measured: post-intervention (6 weeks post-enrollment)
Feasibility as Assessed by the Number of Participants That Complete All Visits
Number of participants that complete all visits defined as participants who completed all study assessments, including baseline visits and immediate post-intervention assessments.
Measured: post-intervention (6 weeks post-enrollment)
Secondary outcomes (24)
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)
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
Measured: Baseline
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)
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
Measured: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
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)
This is a 20 item questionnaire, each is scored from 0(never true) to 6(always true), a higher number indicating higher acceptance
Measured: baseline
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)
This is a 20 item questionnaire, each is scored from 0(never true) to 6(always true), a higher number indicating higher acceptance
Measured: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
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)
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
Measured: Baseline
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)
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
Measured: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
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
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
Measured: Baseline
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
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
Measured: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8)
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).
Measured: Baseline
Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8)
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).
Measured: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
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)
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
Measured: Baseline
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)
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
Measured: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
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)
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
Measured: Baseline
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)
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
Measured: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4)
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
Measured: Baseline
Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4)
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
Measured: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a
Each question has five response options ranging in value from five (very poor) to one (very good), a higher number indicating more fatigue.
Measured: Baseline
Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a
Each question has five response options ranging in value from five (very poor) to one (very good), a higher number indicating more fatigue.
Measured: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2)
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.
Measured: Baseline
Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2)
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.
Measured: post-intervention (6 weeks post-enrollment)
Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2)
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.
Measured: end of study (12 weeks post enrollment)
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
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.
Measured: Baseline
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
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.
Measured: post-intervention (6 weeks post-enrollment)
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
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.
Measured: end of study (12 weeks post enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start6 Dec 2022
- Primary completion16 Jul 2024
- Study completion16 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Sam Houston State University, TIRR Memorial Hermann
- Responsible party
- Principal investigator, Radha Korupolu, The University of Texas Health Science Center, Houston
- Investigators
- Radha Korupolu, MD, Principal investigator, The University of Texas Health Science Center, HoustonChelsea Ratcliff, PhD, Principal investigator, Sam Houston State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556057
- Sponsor's protocol ID
- HSC-MS-22-0035
- Other IDs
- 1R34AT011530-01A1
- Status last verified
- Aug 2025
- First submitted
- 22 Sep 2022
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ratcliff CG, Lohiya S, Robinson-Whelen S, Taylor H, Ahn A, Korupolu R. Mindfulness buffers the association of pain with depression and anxiety among people with spinal cord injury: A cross-sectional study. Rehabil Psychol. 2026 Feb;71(1):62-71. doi: 10.1037/rep0000593. Epub 2024 Nov 11.
PubMed 39531687
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT05556057
- Acronym / sponsor ID
- HSC-MS-22-0035
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Sam Houston State University, TIRR Memorial Hermann
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 27 Sep 2022 (actual)
- Results
- Posted 14 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness meditation(MM) | Experimental | Other: mindfulness meditation(MM) |
| Health Education | Active comparator | Other: Health Education (active control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness meditation(MM)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 | Other | mindfulness meditation(MM) |
| Health Education (active control)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 | Other | Health Education |
Primary outcome
Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent
Time frame: end of study at 3 years
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)
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.
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.
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.
24 secondary outcomes
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4)
Time frame: Baseline
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)
Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a
Time frame: Baseline
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)
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
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)
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)
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
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39531687Ratcliff CG, Lohiya S, Robinson-Whelen S, Taylor H, Ahn A, Korupolu R. Mindfulness buffers the association of pain with depression and anxiety among people with spinal cord injury: A cross-sectional study. Rehabil Psychol. 2026 Feb;71(1):62-71. doi: 10.1037/rep0000593. Epub 2024 Nov 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radha Korupolu, MD principal investigator
The University of Texas Health Science Center, Houston
Chelsea Ratcliff, PhD principal investigator
Sam Houston State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness meditation(MM) in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent (time frame: end of study at 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05556057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.