Trial Outcomes & Findings for Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury (NCT NCT05556057)
NCT ID: NCT05556057
Last Updated: 2025-08-14
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
end of study at 3 years
Results posted on
2025-08-14
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
Baseline characteristics by cohort
| Measure |
Mindfulness Meditation(MM)
n=29 Participants
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
|
Health Education
n=31 Participants
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
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.38 years
STANDARD_DEVIATION 14.97 • n=29 Participants
|
47.65 years
STANDARD_DEVIATION 12.83 • n=31 Participants
|
47.03 years
STANDARD_DEVIATION 13.90 • n=60 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=29 Participants
|
10 Participants
n=31 Participants
|
19 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=29 Participants
|
21 Participants
n=31 Participants
|
41 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=29 Participants
|
5 Participants
n=31 Participants
|
7 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=29 Participants
|
26 Participants
n=31 Participants
|
53 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=29 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=29 Participants
|
5 Participants
n=31 Participants
|
13 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=29 Participants
|
21 Participants
n=31 Participants
|
40 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
1 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=29 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Do not wish to say
|
0 Participants
n=29 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=29 Participants
|
31 participants
n=31 Participants
|
60 participants
n=60 Participants
|
|
Education
Less than 12th grade
|
1 Participants
n=29 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=60 Participants
|
|
Education
High School Graduate/ GED
|
6 Participants
n=29 Participants
|
6 Participants
n=31 Participants
|
12 Participants
n=60 Participants
|
|
Education
Technical/Vocational school
|
3 Participants
n=29 Participants
|
4 Participants
n=31 Participants
|
7 Participants
n=60 Participants
|
|
Education
Some College
|
9 Participants
n=29 Participants
|
8 Participants
n=31 Participants
|
17 Participants
n=60 Participants
|
|
Education
Undergraduate Degree (BA/BS)
|
9 Participants
n=29 Participants
|
4 Participants
n=31 Participants
|
13 Participants
n=60 Participants
|
|
Education
Graduate Degree (MA/Ph.D)
|
1 Participants
n=29 Participants
|
7 Participants
n=31 Participants
|
8 Participants
n=60 Participants
|
|
Employment Status
Full time
|
2 Participants
n=29 Participants
|
5 Participants
n=31 Participants
|
7 Participants
n=60 Participants
|
|
Employment Status
Part-time
|
1 Participants
n=29 Participants
|
3 Participants
n=31 Participants
|
4 Participants
n=60 Participants
|
|
Employment Status
Retired
|
8 Participants
n=29 Participants
|
8 Participants
n=31 Participants
|
16 Participants
n=60 Participants
|
|
Employment Status
Unemployed
|
18 Participants
n=29 Participants
|
15 Participants
n=31 Participants
|
33 Participants
n=60 Participants
|
|
Income
Under $15,000
|
6 Participants
n=29 Participants
|
1 Participants
n=31 Participants
|
7 Participants
n=60 Participants
|
|
Income
$15,000 to $24,999
|
6 Participants
n=29 Participants
|
3 Participants
n=31 Participants
|
9 Participants
n=60 Participants
|
|
Income
$25,000 to $34,999
|
5 Participants
n=29 Participants
|
1 Participants
n=31 Participants
|
6 Participants
n=60 Participants
|
|
Income
$35,000 to $49,999
|
3 Participants
n=29 Participants
|
3 Participants
n=31 Participants
|
6 Participants
n=60 Participants
|
|
Income
$50,000 to $74,999
|
1 Participants
n=29 Participants
|
7 Participants
n=31 Participants
|
8 Participants
n=60 Participants
|
|
Income
$75,000 to $99,999
|
2 Participants
n=29 Participants
|
4 Participants
n=31 Participants
|
6 Participants
n=60 Participants
|
|
Income
$100,000 & over
|
2 Participants
n=29 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=60 Participants
|
|
Income
I do not wish to say
|
0 Participants
n=29 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=60 Participants
|
|
Income
I do not know
|
4 Participants
n=29 Participants
|
6 Participants
n=31 Participants
|
10 Participants
n=60 Participants
|
|
Marital status
Married
|
7 Participants
n=29 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
9 Participants
n=30 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
16 Participants
n=59 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
|
Marital status
Widowed
|
2 Participants
n=29 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
1 Participants
n=30 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
3 Participants
n=59 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
|
Marital status
Divorce or Separated
|
6 Participants
n=29 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
9 Participants
n=30 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
15 Participants
n=59 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
|
Marital status
Living with significant other or partner
|
5 Participants
n=29 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
1 Participants
n=30 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
6 Participants
n=59 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
|
Marital status
Single
|
9 Participants
n=29 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
10 Participants
n=30 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
19 Participants
n=59 Participants • Data for Marital status was not collected from 1 participant in the Health Education arm because they did not answer the question.
|
|
Cause of Spinal Cord Injury (Etiology)
Motor Vehicle Collision (MVC)
|
14 Participants
n=29 Participants
|
14 Participants
n=31 Participants
|
28 Participants
n=60 Participants
|
|
Cause of Spinal Cord Injury (Etiology)
Falls
|
1 Participants
n=29 Participants
|
6 Participants
n=31 Participants
|
7 Participants
n=60 Participants
|
|
Cause of Spinal Cord Injury (Etiology)
Sports
|
2 Participants
n=29 Participants
|
3 Participants
n=31 Participants
|
5 Participants
n=60 Participants
|
|
Cause of Spinal Cord Injury (Etiology)
Assault
|
7 Participants
n=29 Participants
|
6 Participants
n=31 Participants
|
13 Participants
n=60 Participants
|
|
Cause of Spinal Cord Injury (Etiology)
Medical/Surgical
|
5 Participants
n=29 Participants
|
2 Participants
n=31 Participants
|
7 Participants
n=60 Participants
|
|
Cause of Spinal Cord Injury (Etiology)
Other Injury
|
0 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=60 Participants
|
|
Mobility Status
Walk without assistance or an assistive device
|
3 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=60 Participants
|
|
Mobility Status
Walk with assistance or assistive device (e.g., cane, walker, or braces)
|
4 Participants
n=29 Participants
|
4 Participants
n=31 Participants
|
8 Participants
n=60 Participants
|
|
Mobility Status
Use manual/ hybrid wheelchair
|
12 Participants
n=29 Participants
|
16 Participants
n=31 Participants
|
28 Participants
n=60 Participants
|
|
Mobility Status
Use a power wheelchair
|
10 Participants
n=29 Participants
|
10 Participants
n=31 Participants
|
20 Participants
n=60 Participants
|
|
Mobility Status
Other
|
0 Participants
n=29 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=60 Participants
|
|
Pain duration
|
7.39 Months
STANDARD_DEVIATION 9.39 • n=29 Participants
|
7.49 Months
STANDARD_DEVIATION 6.37 • n=31 Participants
|
7.44 Months
STANDARD_DEVIATION 7.97 • n=60 Participants
|
|
Pain Type
Neuropathic pain
|
21 Participants
n=29 Participants
|
23 Participants
n=31 Participants
|
44 Participants
n=60 Participants
|
|
Pain Type
Nociceptive pain
|
8 Participants
n=29 Participants
|
8 Participants
n=31 Participants
|
16 Participants
n=60 Participants
|
|
Neurological level
Cervical (C1-C4)
|
5 Participants
n=29 Participants
|
3 Participants
n=31 Participants
|
8 Participants
n=60 Participants
|
|
Neurological level
Cervical (C5-C8)
|
14 Participants
n=29 Participants
|
12 Participants
n=31 Participants
|
26 Participants
n=60 Participants
|
|
Neurological level
Thoracic (T1-T5)
|
2 Participants
n=29 Participants
|
6 Participants
n=31 Participants
|
8 Participants
n=60 Participants
|
|
Neurological level
Thoracic (T6-T12)
|
5 Participants
n=29 Participants
|
7 Participants
n=31 Participants
|
12 Participants
n=60 Participants
|
|
Neurological level
Lumbar (L1-L5)
|
3 Participants
n=29 Participants
|
3 Participants
n=31 Participants
|
6 Participants
n=60 Participants
|
|
Neurological level
Sacral
|
0 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=60 Participants
|
|
Impairment
Complete
|
7 Participants
n=29 Participants
|
14 Participants
n=31 Participants
|
21 Participants
n=60 Participants
|
|
Impairment
Incomplete
|
20 Participants
n=29 Participants
|
17 Participants
n=31 Participants
|
37 Participants
n=60 Participants
|
|
Impairment
Unknown
|
2 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=60 Participants
|
|
Pain intensity as assessed by the Visual Analog Scale (VAS)
|
6.69 score on a scale
STANDARD_DEVIATION 1.51 • n=29 Participants
|
6.06 score on a scale
STANDARD_DEVIATION 1.50 • n=31 Participants
|
6.36 score on a scale
STANDARD_DEVIATION 1.50 • n=60 Participants
|
PRIMARY outcome
Timeframe: end of study at 3 yearsPopulation: Overall Number of Participants Analyzed represents number of participants screened for study interest prior to enrollment.
Outcome measures
| Measure |
All Eligible Participants
n=70 Participants
All eligible participants
|
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
|
|---|---|---|
|
Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent
|
65 Participants
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=26 Participants
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
|
|---|---|---|
|
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
|
16 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
Feasibility as Assessed by the Number of Participants That Complete All Visits
|
22 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: post-intervention (6 weeks post-enrollment)Population: Data were only collected from participants who completed the survey.
The Client Satisfaction Questionnaire-8 measures satisfaction and the total score ranges from 8 to 32. The greater the score the higher satisfaction.
Outcome measures
| Measure |
All Eligible Participants
n=22 Participants
All eligible participants
|
Health Education
n=19 Participants
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
|
|---|---|---|
|
Acceptability Rate as Assessed by the Number of Participants Who Scored 20 or Greater on the Modified Client Satisfaction Questionnaire-8
|
18 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: post-intervention (6 weeks post-enrollment)Number of participants that complete all visits defined as participants who completed all study assessments, including baseline visits and immediate post-intervention assessments.
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
Feasibility as Assessed by the Number of Participants That Complete All Visits
|
18 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
All Eligible Participants
n=65 Participants
All eligible participants
|
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
|
|---|---|---|
|
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 outcome
Timeframe: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)This survey contains 11 questions and each one is measured from 0(no pain) to 10(chronic pain),with a maximum score of 110, a higher number indicating more pain
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
19 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
|
20 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: 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.
This is a 20 item questionnaire, each is scored from 0(never true) to 6(always true), a higher number indicating higher acceptance
Outcome measures
| Measure |
All Eligible Participants
n=65 Participants
All eligible participants
|
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
|
|---|---|---|
|
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 outcome
Timeframe: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)This is a 20 item questionnaire, each is scored from 0(never true) to 6(always true), a higher number indicating higher acceptance
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
19 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
|
22 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
All Eligible Participants
n=65 Participants
All eligible participants
|
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
|
|---|---|---|
|
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 outcome
Timeframe: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)This measures three aspects of catastrophic cognitions about pain-rumination, magnification, and helplessness. This is a 13 item questionnaire. Each question has five response options ranging from 0 (not at all) to 4 (all the time) scale, with a maximum score of 52
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
19 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
|
22 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
All Eligible Participants
n=65 Participants
All eligible participants
|
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
|
|---|---|---|
|
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 outcome
Timeframe: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)This is an 7 item questionnaire, each is scored from 0(not at all) to 3(nearly every day), a higher score indicating more anxiety
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
19 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
|
22 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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).
Outcome measures
| Measure |
All Eligible Participants
n=65 Participants
All eligible participants
|
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
|
|---|---|---|
|
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 outcome
Timeframe: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)This is an 8 item questionnaire.Each question is scored from 0 to 1 day = "not at all," 2 to 6 days = "several days," 7 to 11 days = "more than half the days," and 12 to 14 days = "nearly every day". Total score is determined by adding together the scores of each of the four items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
19 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
|
22 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
All Eligible Participants
n=65 Participants
All eligible participants
|
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
|
|---|---|---|
|
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 outcome
Timeframe: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)This is a 15 item questionnaire, each is scored from 1(never or very rarely true) to 5(very often or always true) for a maximum score of 120, higher score indicating more mindfulness
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
19 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
|
22 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
All Eligible Participants
n=65 Participants
All eligible participants
|
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
|
|---|---|---|
|
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 outcome
Timeframe: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)This is a 10 item scale each scored from (1)never to (5)always, with a maximum score of 50 a higher number indicating a better outcome
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
19 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
|
22 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
All Eligible Participants
n=65 Participants
All eligible participants
|
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
|
|---|---|---|
|
Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4)
|
64 Participants
|
—
|
SECONDARY outcome
Timeframe: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)The Perceived Stress Scale (PSS-4) is a four-item scale, each item is scored from 0(never) to 4(very often). The total score ranges from 0 to 16, a higher score indicating more stress
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
19 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
|
22 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
Each question has five response options ranging in value from five (very poor) to one (very good), a higher number indicating more fatigue.
Outcome measures
| Measure |
All Eligible Participants
n=65 Participants
All eligible participants
|
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
|
|---|---|---|
|
Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a
|
64 Participants
|
—
|
SECONDARY outcome
Timeframe: post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)Each question has five response options ranging in value from five (very poor) to one (very good), a higher number indicating more fatigue.
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
19 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
|
22 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
All Eligible Participants
n=65 Participants
All eligible participants
|
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
|
|---|---|---|
|
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 outcome
Timeframe: post-intervention (6 weeks post-enrollment)This contains 7 items and answers are given on a 7-point scale ranging from 1 (never true) to 7 (always true). High scores on the AAQ-2 are reflective of greater experiential avoidance and immobility, while low scores reflect greater acceptance and action.
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
19 Participants
|
SECONDARY outcome
Timeframe: end of study (12 weeks post enrollment)This contains 7 items and answers are given on a 7-point scale ranging from 1 (never true) to 7 (always true). High scores on the AAQ-2 are reflective of greater experiential avoidance and immobility, while low scores reflect greater acceptance and action.
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
22 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
All Eligible Participants
n=65 Participants
All eligible participants
|
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
|
|---|---|---|
|
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 outcome
Timeframe: post-intervention (6 weeks post-enrollment)This is a 4 item questionnaire and each question has five response options ranging in value from five (very poor) to one (very good) for a maximum score of 16, higher number indicating worse outcome.
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
19 Participants
|
SECONDARY outcome
Timeframe: end of study (12 weeks post enrollment)This is a 4 item questionnaire and each question has five response options ranging in value from five (very poor) to one (very good) for a maximum score of 16, higher number indicating worse outcome.
Outcome measures
| Measure |
All Eligible Participants
n=24 Participants
All eligible participants
|
Health Education
n=25 Participants
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
|
|---|---|---|
|
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
|
22 Participants
|
Adverse Events
Mindfulness Meditation(MM)
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Health Education
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mindfulness Meditation(MM)
n=29 participants at risk
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
|
Health Education
n=31 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Hospitalized due to spinal cord injury complications
|
6.9%
2/29 • 12 weeks
|
0.00%
0/31 • 12 weeks
|
|
General disorders
Surgery
|
0.00%
0/29 • 12 weeks
|
3.2%
1/31 • 12 weeks
|
Other adverse events
| Measure |
Mindfulness Meditation(MM)
n=29 participants at risk
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
|
Health Education
n=31 participants at risk
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
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
3.4%
1/29 • 12 weeks
|
0.00%
0/31 • 12 weeks
|
Additional Information
Radha Korupolu, MD
The University of Texas Health Science Center at Houston
Phone: 713-797-5233
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place