Trial Outcomes & Findings for Wellness Programs for Brain-Injured Individuals (NCT NCT02600637)

Results Overview

Determine whether the MBSR treatment has any effect on depression by comparing change scores (post-intervention minus pre-intervention) on the Geriatric Depression Scale (GDS) for MBSR versus Education control group. A negative change score indicates improvement in depressive symptomatology. Full score range possible on the GDS is 0-30, where 0 means no depression and 30 means severe depression.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

Over the 8 week assessment period for each participant, up to a total of 5 months

Results posted on

2019-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	MBSR Mindfulness-based Stress Reduction program MBSR: Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms.	Education Educational group program Brain Health class: An 8-week course on brain health will be administered to participants as an active control group.
Overall Study STARTED	19	18
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wellness Programs for Brain-Injured Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MBSR n=19 Participants Mindfulness-based Stress Reduction program MBSR: Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms.	Education n=18 Participants Educational group program Brain Health class: An 8-week course on brain health will be administered to participants as an active control group.	Total n=37 Participants Total of all reporting groups
Age, Continuous	64.8 years STANDARD_DEVIATION 12.0 • n=5 Participants	67.3 years STANDARD_DEVIATION 9.5 • n=7 Participants	66 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized white	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized black	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Over the 8 week assessment period for each participant, up to a total of 5 months

Determine whether the MBSR treatment has any effect on depression by comparing change scores (post-intervention minus pre-intervention) on the Geriatric Depression Scale (GDS) for MBSR versus Education control group. A negative change score indicates improvement in depressive symptomatology. Full score range possible on the GDS is 0-30, where 0 means no depression and 30 means severe depression.

Outcome measures

Outcome measures
Measure	MBSR n=19 Participants Mindfulness-based Stress Reduction program MBSR: Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms.	Education n=18 Participants Educational group program Brain Health class: An 8-week course on brain health will be administered to participants as an active control group.
Depression Score Change on Geriatric Depression Scale	-.29 units on a scale Standard Deviation 3.2	-1.46 units on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: Over the 8 week assessment period for each participant, up to a total of 5 months

Determine whether the MBSR treatment has any effect on anxiety by comparing change score (post-intervention minus pre-intervention) on State-Trait Anxiety Inventory (STAI) for MBSR versus Education control group. A negative change score indicates improvement in anxiety symptoms. Full range of scores on the STAI is 20-80, where 20 is minimal/no anxiety and 80 is severe anxiety.

Outcome measures

Outcome measures
Measure	MBSR n=19 Participants Mindfulness-based Stress Reduction program MBSR: Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms.	Education n=18 Participants Educational group program Brain Health class: An 8-week course on brain health will be administered to participants as an active control group.
Anxiety Score Change on State-Trait Anxiety Inventory Questionnaire	.57 units on a scale Standard Deviation .21	-2.31 units on a scale Standard Deviation .7

SECONDARY outcome

Timeframe: Over the 8 week assessment period for each participant, up to a total of 5 months

Determine whether the MBSR treatment has any effect on overall cognitive performance by comparing the change score (post-intervention minus pre-intervention) in overall Cognitive standard score on RBANS for MBSR versus Education control group. Positive change score indicates improvement in overall cognitive performance. The possible range of standard scores on the RBANS is 40-154, where 40 is severely impaired cognition and 154 is superior range cognition.

Outcome measures

Outcome measures
Measure	MBSR n=19 Participants Mindfulness-based Stress Reduction program MBSR: Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms.	Education n=18 Participants Educational group program Brain Health class: An 8-week course on brain health will be administered to participants as an active control group.
Repeatable Battery for Assessment of Neuropsychological Status Battery Overall Cognitive Change Score	7.69 units on a scale Standard Deviation 1.2	3.08 units on a scale Standard Deviation .4

Adverse Events

MBSR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Juliana Baldo

VA Northern California

Phone: 925-372-4649

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place