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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34AT011530-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Sam Houston State University | OTHER |
| TIRR Memorial Hermann | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mindfulness meditation(MM) | Experimental |
| |
| Health Education | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent | 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 | 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. | 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. | 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. | post-intervention (6 weeks post-enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Radha Korupolu, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Chelsea Ratcliff, PhD | Sam Houston State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States | ||
| TIRR Memorial Hermann |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39531687 | Derived | 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. |
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Of the 70 participants screened 65 were eligible and enrolled. Of the 65 participants enrolled, 60 were randomized. 4 participants were unreachable prior to randomization and 1 participant withdrew before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Meditation(MM) | 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 |
| FG001 | Health Education | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Includes all participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Meditation(MM) | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent | Overall Number of Participants Analyzed represents number of participants screened for study interest prior to enrollment. | Posted | Count of Participants | Participants | end of study at 3 years |
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness Meditation(MM) | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized due to spinal cord injury complications | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Radha Korupolu, MD | The University of Texas Health Science Center at Houston | 713-797-5233 | Radha.Korupolu@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2024 | Jul 15, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 27, 2024 | Jul 15, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| 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 |
|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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). | 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). | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | end of study (12 weeks post enrollment) |
| Houston |
| Texas |
| 77030 |
| United States |
| BG001 | Health Education | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| Marital status | Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question. | Count of Participants | Participants |
|
| Cause of Spinal Cord Injury (Etiology) | Count of Participants | Participants |
|
| Mobility Status | Count of Participants | Participants |
|
| Pain duration | Mean | Standard Deviation | Months |
|
| Pain Type | Count of Participants | Participants |
|
| Neurological level | The neurological level of injury is defined as the lowest segment of the spinal cord with normal sensory and motor function on both sides, based on the American Spinal Injury Association (ASIA) criteria. This level is determined by assessing key sensory points and motor functions. For this outcome, neurological levels are categorized as follows: Cervical (C1-C4) Cervical (C5-C8) Thoracic (T1-T5) Thoracic (T6-T12) Lumbar (L1-L5) Sacral | Count of Participants | Participants |
|
| Impairment | Impairment is classified as either Complete or Incomplete based on the ASIA Impairment Scale (AIS). Complete impairment corresponds to AIS A, indicating a complete injury with no sensory or motor function is preserved in the sacral segments (S4-S5). Incomplete impairment corresponds to AIS B-D, where some sensory and/or motor function is preserved below the neurological level, including the sacral segments. | Count of Participants | Participants |
|
| Pain intensity as assessed by the Visual Analog Scale (VAS) | VAS pain scale is a range of scores from 0-10. A higher score indicates greater pain intensity. | Mean | Standard Deviation | score on a scale |
|
|
| Primary | 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 | Data were not collected from 5 participants in the Health Education arm because the 3 participants withdrew from the study and 2 participants were lost to follow up. Data were not collected from 5 participants in the mindfulness meditation arm because 4 participants were lost to follow up and 1 withdrew from the study. | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment) |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | end of study (12 weeks post enrollment) |
|
|
|
| Primary | 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. | Data were only collected from participants who completed the survey. | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment) |
|
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| Primary | 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. | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment) |
|
|
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| Secondary | 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 | Feasibility outcome measures were pre-specified to be collected as a single group at baseline, this data was collected prior to randomization. Enrolled participants are defined as those who provided informed consent prior to randomization. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment) |
|
|
|
| Secondary | 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 | Feasibility outcome measures were pre-specified to be collected as a single group at baseline, this data was collected prior to randomization. Enrolled participants are defined as those who provided informed consent prior to randomization. | Posted | Count of Participants | Participants | baseline |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment) |
|
|
|
| Secondary | 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 | Feasibility outcome measures were pre-specified to be collected as a single group at baseline, this data was collected prior to randomization. Enrolled participants are defined as those who provided informed consent prior to randomization. | Posted | Count of Participants | Participants | Baseline |
|
|
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| Secondary | 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 | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment) |
|
|
|
| Secondary | 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 | Feasibility outcome measures were pre-specified to be collected as a single group at baseline, this data was collected prior to randomization. Enrolled participants are defined as those who provided informed consent prior to randomization. | Posted | Count of Participants | Participants | Baseline |
|
|
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| Secondary | 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 | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment) |
|
|
|
| Secondary | 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). | Feasibility outcome measures were pre-specified to be collected as a single group at baseline, this data was collected prior to randomization. Enrolled participants are defined as those who provided informed consent prior to randomization. | Posted | Count of Participants | Participants | Baseline |
|
|
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| Secondary | 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). | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment) |
|
|
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| Secondary | 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 | Feasibility outcome measures were pre-specified to be collected as a single group at baseline, this data was collected prior to randomization. Enrolled participants are defined as those who provided informed consent prior to randomization. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment) |
|
|
|
| Secondary | 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 | Feasibility outcome measures were pre-specified to be collected as a single group at baseline, this data was collected prior to randomization. Enrolled participants are defined as those who provided informed consent prior to randomization. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | 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 | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment) |
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| Secondary | 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 | Feasibility outcome measures were pre-specified to be collected as a single group at baseline, this data was collected prior to randomization. Enrolled participants are defined as those who provided informed consent prior to randomization. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | 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 | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment) |
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| Secondary | 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. | Feasibility outcome measures were pre-specified to be collected as a single group at baseline, this data was collected prior to randomization. Enrolled participants are defined as those who provided informed consent prior to randomization. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | 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. | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment) |
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| Secondary | 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. | Feasibility outcome measures were pre-specified to be collected as a single group at baseline, this data was collected prior to randomization. Enrolled participants are defined as those who provided informed consent prior to randomization. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | 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. | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment) |
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|
|
| Secondary | 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. | Posted | Count of Participants | Participants | end of study (12 weeks post enrollment) |
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| Secondary | 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. | Feasibility outcome measures were pre-specified to be collected as a single group at baseline, this data was collected prior to randomization. Enrolled participants are defined as those who provided informed consent prior to randomization. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | 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. | Posted | Count of Participants | Participants | post-intervention (6 weeks post-enrollment) |
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| Secondary | 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. | Posted | Count of Participants | Participants | end of study (12 weeks post enrollment) |
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|
|
| 0 |
| 29 |
| 2 |
| 29 |
| 1 |
| 29 |
| EG001 | Health Education | 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 | 0 | 31 | 1 | 31 | 0 | 31 |
| Surgery | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D014947 | Wounds and Injuries |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than One Race |
|
| Unknown or Not Reported |
|
| Do not wish to say |
|
| Technical/Vocational school |
|
| Some College |
|
| Undergraduate Degree (BA/BS) |
|
| Graduate Degree (MA/Ph.D) |
|
| Retired |
|
| Unemployed |
|
| $25,000 to $34,999 |
|
| $35,000 to $49,999 |
|
| $50,000 to $74,999 |
|
| $75,000 to $99,999 |
|
| $100,000 & over |
|
| I do not wish to say |
|
| I do not know |
|
| Divorce or Separated |
|
| Living with significant other or partner |
|
| Single |
|
| Sports |
|
| Assault |
|
| Medical/Surgical |
|
| Other Injury |
|
| Use manual/ hybrid wheelchair |
|
| Use a power wheelchair |
|
| Other |
|
| Thoracic (T1-T5) |
|
| Thoracic (T6-T12) |
|
| Lumbar (L1-L5) |
|
| Sacral |
|
| Unknown |
|