Spinal Cord Injuries
Conditions
Brief 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
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.
Interventions
OTHERmindfulness 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
OTHERHealth 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
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Sam Houston State University
TIRR Memorial Hermann
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8) | 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). |
| 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) | 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 |
| 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) | 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 |
| 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) | 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 |
| Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a | Baseline | Each question has five response options ranging in value from five (very poor) to one (very good), a higher number indicating more fatigue. |
| Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2) | 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. |
| 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 | 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. |
| Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4) | 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 |
| 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) | baseline | This is a 20 item questionnaire, each is scored from 0(never true) to 6(always true), a higher number indicating higher acceptance |
| 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) | 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 |
| 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 | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 29 |
| 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 | 31 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Mindfulness Meditation(MM) | Health Education | Total |
|---|---|---|---|
| Age, Continuous | 46.38 years STANDARD_DEVIATION 14.97 | 47.65 years STANDARD_DEVIATION 12.83 | 47.03 years STANDARD_DEVIATION 13.9 |
| Cause of Spinal Cord Injury (Etiology) Assault | 7 Participants | 6 Participants | 13 Participants |
| Cause of Spinal Cord Injury (Etiology) Falls | 1 Participants | 6 Participants | 7 Participants |
| Cause of Spinal Cord Injury (Etiology) Medical/Surgical | 5 Participants | 2 Participants | 7 Participants |
| Cause of Spinal Cord Injury (Etiology) Motor Vehicle Collision (MVC) | 14 Participants | 14 Participants | 28 Participants |
| Cause of Spinal Cord Injury (Etiology) Other Injury | 0 Participants | 0 Participants | 0 Participants |
| Cause of Spinal Cord Injury (Etiology) Sports | 2 Participants | 3 Participants | 5 Participants |
| Education Graduate Degree (MA/Ph.D) | 1 Participants | 7 Participants | 8 Participants |
| Education High School Graduate/ GED | 6 Participants | 6 Participants | 12 Participants |
| Education Less than 12th grade | 1 Participants | 2 Participants | 3 Participants |
| Education Some College | 9 Participants | 8 Participants | 17 Participants |
| Education Technical/Vocational school | 3 Participants | 4 Participants | 7 Participants |
| Education Undergraduate Degree (BA/BS) | 9 Participants | 4 Participants | 13 Participants |
| Employment Status Full time | 2 Participants | 5 Participants | 7 Participants |
| Employment Status Part-time | 1 Participants | 3 Participants | 4 Participants |
| Employment Status Retired | 8 Participants | 8 Participants | 16 Participants |
| Employment Status Unemployed | 18 Participants | 15 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 26 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Impairment Complete | 7 Participants | 14 Participants | 21 Participants |
| Impairment Incomplete | 20 Participants | 17 Participants | 37 Participants |
| Impairment Unknown | 2 Participants | 0 Participants | 2 Participants |
| Income $100,000 & over | 2 Participants | 2 Participants | 4 Participants |
| Income $15,000 to $24,999 | 6 Participants | 3 Participants | 9 Participants |
| Income $25,000 to $34,999 | 5 Participants | 1 Participants | 6 Participants |
| Income $35,000 to $49,999 | 3 Participants | 3 Participants | 6 Participants |
| Income $50,000 to $74,999 | 1 Participants | 7 Participants | 8 Participants |
| Income $75,000 to $99,999 | 2 Participants | 4 Participants | 6 Participants |
| Income I do not know | 4 Participants | 6 Participants | 10 Participants |
| Income I do not wish to say | 0 Participants | 4 Participants | 4 Participants |
| Income Under $15,000 | 6 Participants | 1 Participants | 7 Participants |
| Marital status Divorce or Separated | 6 Participants | 9 Participants | 15 Participants |
| Marital status Living with significant other or partner | 5 Participants | 1 Participants | 6 Participants |
| Marital status Married | 7 Participants | 9 Participants | 16 Participants |
| Marital status Single | 9 Participants | 10 Participants | 19 Participants |
| Marital status Widowed | 2 Participants | 1 Participants | 3 Participants |
| Mobility Status Other | 0 Participants | 1 Participants | 1 Participants |
| Mobility Status Use a power wheelchair | 10 Participants | 10 Participants | 20 Participants |
| Mobility Status Use manual/ hybrid wheelchair | 12 Participants | 16 Participants | 28 Participants |
| Mobility Status Walk with assistance or assistive device (e.g., cane, walker, or braces) | 4 Participants | 4 Participants | 8 Participants |
| Mobility Status Walk without assistance or an assistive device | 3 Participants | 0 Participants | 3 Participants |
| Neurological level Cervical (C1-C4) | 5 Participants | 3 Participants | 8 Participants |
| Neurological level Cervical (C5-C8) | 14 Participants | 12 Participants | 26 Participants |
| Neurological level Lumbar (L1-L5) | 3 Participants | 3 Participants | 6 Participants |
| Neurological level Sacral | 0 Participants | 0 Participants | 0 Participants |
| Neurological level Thoracic (T1-T5) | 2 Participants | 6 Participants | 8 Participants |
| Neurological level Thoracic (T6-T12) | 5 Participants | 7 Participants | 12 Participants |
| Pain duration | 7.39 Months STANDARD_DEVIATION 9.39 | 7.49 Months STANDARD_DEVIATION 6.37 | 7.44 Months STANDARD_DEVIATION 7.97 |
| Pain intensity as assessed by the Visual Analog Scale (VAS) | 6.69 score on a scale STANDARD_DEVIATION 1.51 | 6.06 score on a scale STANDARD_DEVIATION 1.5 | 6.36 score on a scale STANDARD_DEVIATION 1.5 |
| Pain Type Neuropathic pain | 21 Participants | 23 Participants | 44 Participants |
| Pain Type Nociceptive pain | 8 Participants | 8 Participants | 16 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 8 Participants | 5 Participants | 13 Participants |
| Race/Ethnicity, Customized Do not wish to say | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized More than One Race | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 19 Participants | 21 Participants | 40 Participants |
| Region of Enrollment United States | 29 participants | 31 participants | 60 participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 31 |
| other Total, other adverse events | 1 / 29 | 0 / 31 |
| serious Total, serious adverse events | 2 / 29 | 1 / 31 |
Outcome results
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.
Time frame: post-intervention (6 weeks post-enrollment)
Population: Data were only collected from participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | Acceptability Rate as Assessed by the Number of Participants Who Scored 20 or Greater on the Modified Client Satisfaction Questionnaire-8 | 18 Participants |
| Health Education | Acceptability Rate as Assessed by the Number of Participants Who Scored 20 or Greater on the Modified Client Satisfaction Questionnaire-8 | 19 Participants |
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.
Time frame: post-intervention (6 weeks post-enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | Feasibility as Assessed by the Number of Participants That Complete All Visits | 18 Participants |
| Health Education | Feasibility as Assessed by the Number of Participants That Complete All Visits | 19 Participants |
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.
Time frame: end of study (12 weeks post enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | Feasibility as Assessed by the Number of Participants That Complete All Visits | 22 Participants |
| Health Education | Feasibility as Assessed by the Number of Participants That Complete All Visits | 20 Participants |
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
Time frame: post-intervention (6 weeks post-enrollment)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | 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 | 15 Participants |
| Health Education | 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 | 16 Participants |
Primary
Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent
Time frame: end of study at 3 years
Population: Overall Number of Participants Analyzed represents number of participants screened for study interest prior to enrollment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent | 65 Participants |
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.
Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Participants | Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a | post-intervention (6 weeks post-enrollment) | 20 Participants |
| All Eligible Participants | Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a | end of study (12 weeks post enrollment) | 23 Participants |
| Health Education | Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a | post-intervention (6 weeks post-enrollment) | 19 Participants |
| Health Education | Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a | end of study (12 weeks post enrollment) | 22 Participants |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a | 64 Participants |
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
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | 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 | 64 Participants |
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
Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Participants | 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 | post-intervention (6 weeks post-enrollment) | 20 Participants |
| All Eligible Participants | 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 | end of study (12 weeks post enrollment) | 23 Participants |
| Health Education | 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 | post-intervention (6 weeks post-enrollment) | 19 Participants |
| Health Education | 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 | end of study (12 weeks post enrollment) | 22 Participants |
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
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | 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) | 60 Participants |
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
Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Participants | 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) | post-intervention (6 weeks post-enrollment) | 20 Participants |
| All Eligible Participants | 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) | end of study (12 weeks post enrollment) | 23 Participants |
| Health Education | 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) | post-intervention (6 weeks post-enrollment) | 19 Participants |
| Health Education | 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) | end of study (12 weeks post enrollment) | 22 Participants |
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).
Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Participants | Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8) | post-intervention (6 weeks post-enrollment) | 20 Participants |
| All Eligible Participants | Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8) | end of study (12 weeks post enrollment) | 23 Participants |
| Health Education | Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8) | post-intervention (6 weeks post-enrollment) | 19 Participants |
| Health Education | Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8) | end of study (12 weeks post enrollment) | 22 Participants |
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).
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8) | 64 Participants |
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
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | 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) | 64 Participants |
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
Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Participants | 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) | post-intervention (6 weeks post-enrollment) | 20 Participants |
| All Eligible Participants | 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) | end of study (12 weeks post enrollment) | 23 Participants |
| Health Education | 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) | post-intervention (6 weeks post-enrollment) | 19 Participants |
| Health Education | 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) | end of study (12 weeks post enrollment) | 22 Participants |
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
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | 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) | 60 Participants |
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
Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Participants | 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) | post-intervention (6 weeks post-enrollment) | 18 Participants |
| All Eligible Participants | 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) | end of study (12 weeks post enrollment) | 22 Participants |
| Health Education | 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) | post-intervention (6 weeks post-enrollment) | 19 Participants |
| Health Education | 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) | end of study (12 weeks post enrollment) | 20 Participants |
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
Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Participants | 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) | end of study (12 weeks post enrollment) | 23 Participants |
| All Eligible Participants | 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) | post-intervention (6 weeks post-enrollment) | 20 Participants |
| Health Education | 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) | post-intervention (6 weeks post-enrollment) | 19 Participants |
| Health Education | 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) | end of study (12 weeks post enrollment) | 22 Participants |
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
Time frame: baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | 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) | 60 Participants |
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
Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Participants | 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) | post-intervention (6 weeks post-enrollment) | 20 Participants |
| All Eligible Participants | 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) | end of study (12 weeks post enrollment) | 23 Participants |
| Health Education | 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) | post-intervention (6 weeks post-enrollment) | 19 Participants |
| Health Education | 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) | end of study (12 weeks post enrollment) | 22 Participants |
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
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | 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) | 64 Participants |
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
Time frame: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Participants | Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4) | post-intervention (6 weeks post-enrollment) | 20 Participants |
| All Eligible Participants | Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4) | end of study (12 weeks post enrollment) | 23 Participants |
| Health Education | Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4) | post-intervention (6 weeks post-enrollment) | 19 Participants |
| Health Education | Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4) | end of study (12 weeks post enrollment) | 22 Participants |
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
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4) | 64 Participants |
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.
Time frame: post-intervention (6 weeks post-enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2) | 20 Participants |
| Health Education | Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2) | 19 Participants |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2) | 64 Participants |
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.
Time frame: end of study (12 weeks post enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2) | 23 Participants |
| Health Education | Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2) | 22 Participants |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | 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 | 64 Participants |
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.
Time frame: post-intervention (6 weeks post-enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | 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 | 20 Participants |
| Health Education | 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 | 19 Participants |
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.
Time frame: end of study (12 weeks post enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Participants | 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 | 23 Participants |
| Health Education | 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 | 22 Participants |