Trial Outcomes & Findings for Awareness and Self-Compassion Enhancing Narcolepsy Treatment (NCT NCT04306952)
NCT ID: NCT04306952
Last Updated: 2024-08-20
Results Overview
Number of participants who attended greater than or equal to 80% of sessions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Brief MBI
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Awareness and Self-Compassion Enhancing Narcolepsy Treatment
Baseline characteristics by cohort
| Measure |
Brief MBI
n=20 Participants
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 Participants
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 Participants
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Non-binary
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Patient-Reported Outcomes Measurement Information System Depression
|
59.53 T-Score
STANDARD_DEVIATION 4.76 • n=5 Participants
|
56.11 T-Score
STANDARD_DEVIATION 4.81 • n=7 Participants
|
60.06 T-Score
STANDARD_DEVIATION 6.25 • n=5 Participants
|
58.57 T-Score
STANDARD_DEVIATION 5.52 • n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)Number of participants who attended greater than or equal to 80% of sessions
Outcome measures
| Measure |
Brief MBI
n=20 Participants
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 Participants
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 Participants
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Number of Participants Who Attended ≥ 80% of Sessions
|
15 Participants
|
13 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)Number of participants who practiced meditation greater than or equal to 4 days per week
Outcome measures
| Measure |
Brief MBI
n=20 Participants
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 Participants
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 Participants
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Number of Participants Who Practiced Meditation ≥ 4 Days Per Week
|
16 Participants
|
8 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)Number of participants who completed entire baseline and post-treatment assessment (questionnaires, actigraphy, and neurocognitive testing)
Outcome measures
| Measure |
Brief MBI
n=20 Participants
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 Participants
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 Participants
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Number of Participants Who Completed Assessments
|
18 Participants
|
13 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)Population: Post-treatment scores not available for participants who did not complete the assessment
The SCS assesses the acquisition of self-compassion. It is a 26-item self report measure with three main components of self-compassion: self-kindness vs. self-judgement, common humanity vs. isolation, and mindfulness vs. over-identification. The total score ranges from 1-5, with higher scores reflecting more self-compassion.
Outcome measures
| Measure |
Brief MBI
n=20 Participants
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 Participants
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 Participants
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Self-Compassion Scale (SCS)
Baseline
|
2.66 score on a scale
Standard Deviation .80
|
2.91 score on a scale
Standard Deviation .82
|
2.52 score on a scale
Standard Deviation .50
|
|
Self-Compassion Scale (SCS)
Post-treatment
|
3.12 score on a scale
Standard Deviation .86
|
3.58 score on a scale
Standard Deviation .58
|
3.61 score on a scale
Standard Deviation .61
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)Population: Post-treatment scores not available for participants who did not complete the assessment
The FFMQ assesses the acquisition of mindfulness skills. It is a 39-item self-report measure that consists of five factors representing elements of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Total scores range from 39-195, with higher scores reflecting more mindfulness.
Outcome measures
| Measure |
Brief MBI
n=20 Participants
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 Participants
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 Participants
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Five Facet Mindfulness Questionnaire (FFMQ)
Baseline
|
115.90 score on a scale
Standard Deviation 24.80
|
122.50 score on a scale
Standard Deviation 22.13
|
107.00 score on a scale
Standard Deviation 13.43
|
|
Five Facet Mindfulness Questionnaire (FFMQ)
Post-treatment
|
132.42 score on a scale
Standard Deviation 21.91
|
144.00 score on a scale
Standard Deviation 16.11
|
136.53 score on a scale
Standard Deviation 19.42
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)Population: Post-treatment scores not available for participants who did not complete the assessment
Measures the direct positive psychosocial effect related to illness with higher scores reflecting better outcomes. Population mean (T-score) of 50 with a standard deviation of 10.
Outcome measures
| Measure |
Brief MBI
n=20 Participants
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 Participants
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 Participants
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Positive
Post-treatment
|
42.83 T-score
Standard Deviation 8.92
|
46.94 T-score
Standard Deviation 8.26
|
43.85 T-score
Standard Deviation 9.02
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Positive
Baseline
|
39.35 T-score
Standard Deviation 8.00
|
42.07 T-score
Standard Deviation 6.84
|
38.74 T-score
Standard Deviation 7.23
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)Population: Post-treatment scores not available for participants who did not complete the assessment
Measures the direct negative psychosocial effect related to illness with higher scores reflecting worse outcomes. Population mean (T-score) of 50 with a standard deviation of 10.
Outcome measures
| Measure |
Brief MBI
n=20 Participants
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 Participants
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 Participants
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Negative Scale
Baseline
|
60.94 T-score
Standard Deviation 6.53
|
59.35 T-score
Standard Deviation 5.28
|
62.59 T-score
Standard Deviation 8.26
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Negative Scale
Post-treatment
|
58.70 T-score
Standard Deviation 10.09
|
56.52 T-score
Standard Deviation 6.24
|
57.28 T-score
Standard Deviation 6.75
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)Population: Post-treatment scores not available for participants who did not complete the assessment
Measures overall physical and mental health with higher scores reflecting better outcomes. Population mean (T-score) of 50 with a standard deviation of 10.
Outcome measures
| Measure |
Brief MBI
n=20 Participants
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 Participants
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 Participants
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale
Global Mental Health (Baseline)
|
38.01 T-score
Standard Deviation 7.89
|
40.43 T-score
Standard Deviation 6.07
|
36.03 T-score
Standard Deviation 7.82
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale
Global Mental Health (Post-treatment)
|
41.17 T-score
Standard Deviation 10.09
|
44.77 T-score
Standard Deviation 7.35
|
42.73 T-score
Standard Deviation 8.09
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale
Global Physical Health (Baseline)
|
46.32 T-score
Standard Deviation 7.46
|
43.85 T-score
Standard Deviation 6.15
|
43.71 T-score
Standard Deviation 6.44
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale
Global Physical Health (Post-treatment)
|
47.41 T-score
Standard Deviation 8.16
|
46.32 T-score
Standard Deviation 6.82
|
45.12 T-score
Standard Deviation 8.32
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)Population: Post-treatment scores not available for participants who did not complete the assessment
Measures anxiety symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.
Outcome measures
| Measure |
Brief MBI
n=20 Participants
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 Participants
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 Participants
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Baseline
|
62.54 T-score
Standard Deviation 7.04
|
61.24 T-score
Standard Deviation 4.85
|
61.69 T-score
Standard Deviation 6.67
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Post-treatment
|
62.46 T-score
Standard Deviation 9.79
|
56.62 T-score
Standard Deviation 6.25
|
58.04 T-score
Standard Deviation 7.48
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)Population: Post-treatment scores not available for participants who did not complete the assessment
Measures depressive symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more depressive symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.
Outcome measures
| Measure |
Brief MBI
n=20 Participants
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 Participants
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 Participants
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Baseline
|
59.53 T-score
Standard Deviation 4.76
|
56.11 T-score
Standard Deviation 4.81
|
60.06 T-score
Standard Deviation 6.25
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Post-treatment
|
57.70 T-score
Standard Deviation 9.08
|
53.89 T-score
Standard Deviation 6.30
|
52.73 T-score
Standard Deviation 6.08
|
Adverse Events
Brief MBI
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Standard MBI
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Extended MBI
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brief MBI
n=20 participants at risk
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 participants at risk
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 participants at risk
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Cardiac disorders
Stent placement
|
0.00%
0/20 • 12 weeks (all groups)
|
5.0%
1/20 • Number of events 1 • 12 weeks (all groups)
|
0.00%
0/20 • 12 weeks (all groups)
|
Other adverse events
| Measure |
Brief MBI
n=20 participants at risk
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Brief MBI: The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
|
Standard MBI
n=20 participants at risk
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Standard MBI: The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
|
Extended MBI
n=20 participants at risk
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Extended MBI: The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Actigraphy-related skin irritation
|
5.0%
1/20 • Number of events 1 • 12 weeks (all groups)
|
10.0%
2/20 • Number of events 2 • 12 weeks (all groups)
|
0.00%
0/20 • 12 weeks (all groups)
|
|
Psychiatric disorders
Exacerbation of pre-existing depression
|
10.0%
2/20 • Number of events 3 • 12 weeks (all groups)
|
0.00%
0/20 • 12 weeks (all groups)
|
0.00%
0/20 • 12 weeks (all groups)
|
|
Injury, poisoning and procedural complications
Car accident
|
0.00%
0/20 • 12 weeks (all groups)
|
5.0%
1/20 • Number of events 1 • 12 weeks (all groups)
|
0.00%
0/20 • 12 weeks (all groups)
|
|
Infections and infestations
Infection
|
0.00%
0/20 • 12 weeks (all groups)
|
5.0%
1/20 • Number of events 1 • 12 weeks (all groups)
|
5.0%
1/20 • Number of events 1 • 12 weeks (all groups)
|
|
Nervous system disorders
Migraine
|
0.00%
0/20 • 12 weeks (all groups)
|
5.0%
1/20 • Number of events 1 • 12 weeks (all groups)
|
0.00%
0/20 • 12 weeks (all groups)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
10.0%
2/20 • Number of events 2 • 12 weeks (all groups)
|
0.00%
0/20 • 12 weeks (all groups)
|
0.00%
0/20 • 12 weeks (all groups)
|
|
Nervous system disorders
Increased sleepiness
|
5.0%
1/20 • Number of events 1 • 12 weeks (all groups)
|
0.00%
0/20 • 12 weeks (all groups)
|
0.00%
0/20 • 12 weeks (all groups)
|
|
Skin and subcutaneous tissue disorders
Melanoma
|
5.0%
1/20 • Number of events 1 • 12 weeks (all groups)
|
0.00%
0/20 • 12 weeks (all groups)
|
0.00%
0/20 • 12 weeks (all groups)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place