MBSR During AI Therapy for Breast Cancer

• Sponsor: New York University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03253627
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 23
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This study will use non-invasive neuroimaging (i.e., MRI) to examine whether Mindfulness-Based Stress Reduction (MBSR) improves neural markers of cognitive function for postmenopausal women taking aromatase inhibitor (AI) therapy for breast cancer. The pilot randomized controlled trial will obtain preliminary efficacy of MBSR versus Health Enhancement Program (HEP) active control to improve neural markers of cognitive function. The final sample will include 32 postmenopausal women with breast cancer. MBSR and HEP groups will meet for a matched schedule of 8 weekly 2.5-hour sessions and a one-day weekend retreat. Specimen and data collection will be done at three time points: pre-randomization (i.e., within three weeks before beginning the intervention), within three weeks after completion of the intervention, and approximately three months (+/- three weeks) post intervention. Change scores for neuroimaging parameter estimates will be correlated with change scores for measures of cognitive function and affect. Differential expression of genes will be correlated with neuroimaging parameter estimates.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Cognitive Symptom	Behavioral: Health Enhancement Program; Behavioral: Mindfulness-Based Stress Reduction	N/A

Detailed Description

Adjuvant aromatase inhibitor (AI) therapy improves disease-free and overall survival for postmenopausal women after surgery for hormone receptor-positive breast cancer. Among symptoms associated with AI therapy are changes in cognitive function. Up to 25% of postmenopausal women with breast cancer report that they experience changes in cognitive function during AI therapy. Studies using neuropsychological tests found subtle deteriorations in verbal and visual learning and memory-as well as concentration, working memory, and executive function-for as many as a third of these patients. Changes in cognitive function may be associated with changes in affect (e.g., worry, depressive symptoms). Neural markers of cognitive changes, including changes in brain function and structure, may underlie changes in cognitive function.

The investigators' recent preliminary neuroimaging work to describe neural markers of cognitive changes suggests that postmenopausal women with breast cancer have inefficient cognitive-emotion processing before AI therapy, as evidenced by greater neural activity in the hippocampus (working memory) and amygdala (emotion processing) during task performance compared to controls. During AI therapy, patients show differential activation compared to controls in the dorsolateral prefrontal cortex (executive function and working memory), medial prefrontal cortices (cortical control of amygdala responses), and hippocampus.

Stress responses could partially explain relationships between AI therapy and neural markers of cognitive changes. The Mindfulness Stress-Buffering Account suggests that interventions such as Mindfulness-Based Stress Reduction (MBSR) may improve stress responses by attenuating negative appraisals of stress and reducing reactivity to stressful situations. For example, mindfulness meditation improved psychological stress responses in women with breast cancer. It improved some measures of cognitive function. Mindfulness practices reduced physiological markers of stress responses, including inflammatory markers in women with breast cancer and in stressed community adults, as well as cortisol reactivity for breast cancer survivors and during chemotherapy for colorectal cancer. Although similar neural deficits as were found in the investigators' preliminary work have been shown to improve in stressed adult populations using MBSR, it is not known whether the intervention improves neural deficits in women taking AI therapy (estrogen, production of which is blocked by AI therapy, is neuroprotective and promotes neural plasticity). Genetic variability was previously found to moderate the effect of MBSR on self-reported cognitive function. Therefore, it is possible that inter-individual variability in the expression of genes involved in stress responses could moderate relationships between AI therapy and neural markers of cognitive changes during MBSR. Taken together, MBSR may improve neural markers of cognitive changes shown in preliminary work to be deficient in postmenopausal women before and during AI therapy for breast cancer by targeting stress responses. Changes in these neural markers may correspond to improved self-report and neuropsychological measures of cognitive function.

Hypothesis: Stress reduction, moderated by gene expression, blunts the impact of AI therapy on neural markers of cognitive function, thereby improving cognitive function and affect in women with breast cancer.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A pilot, single-center randomized controlled trial of the preliminary efficacy of an eight-week, group-based Mindfulness-Based Stress Reduction intervention versus Health Enhancement Program active control (i.e., two groups, parallel design) to improve neural markers of changes in cognitive function in postmenopausal women receiving aromatase inhibitor therapy for breast cancer. Participants will be stratified in a permuted block design by receipt of chemotherapy (i.e., two strata). Data will be collected at up to three time points using a repeated measures design (i.e., pre-intervention, post-intervention, approximately three months after the intervention). The study groups will meet at NYU for MBSR or HEP. Neuropsychological, self-report, and biospecimen data collection will be conducted at the Bluestone Center. Neuroimaging data will be collected at the NYU Center for Brain Imaging.A pilot, single-center randomized controlled trial of the preliminary efficacy of an eight-week, group-based Mindfulness-Based Stress Reduction intervention versus Health Enhancement Program active control (i.e., two groups, parallel design) to improve neural markers of changes in cognitive function in postmenopausal women receiving aromatase inhibitor therapy for breast cancer. Participants will be stratified in a permuted block design by receipt of chemotherapy (i.e., two strata). Data will be collected at up to three time points using a repeated measures design (i.e., pre-intervention, post-intervention, approximately three months after the intervention). The study groups will meet at NYU for MBSR or HEP. Neuropsychological, self-report, and biospecimen data collection will be conducted at the Bluestone Center. Neuroimaging data will be collected at the NYU Center for Brain Imaging.
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Participants will complete the baseline assessment and be randomly assigned to study group in a permuted block design stratified by receipt of chemotherapy (i.e., two strata). It will not be possible to blind study participants or interventionists to group assignment. To reduce bias, research staff who conduct assessments, including the PI, will be blinded to group assignment (i.e., single blind). Participants will be reminded not to reveal their group assignment to study staff conducting assessments. The study biostatistician will have no direct contact with study participants and will not be blinded to group assignment. The biostatistician will produce and maintain the randomization codes for the permuted blocks. Randomization may only be unmasked by the biostatistician at the completion of data collection, or for reporting of serious adverse events or unanticipated problems for which it will be essential to provide information to the PI on group assignment.
• Primary Purpose: Supportive Care
• Official Title: Mindfulness-Based Stress Reduction To Improve Cognitive Function for Postmenopausal Women With Breast Cancer
• Actual Study Start Date: Apr 23, 2018
• Actual Primary Completion Date: Dec 10, 2019
• Actual Study Completion Date: Sep 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MBSR Mindfulness-Based Stress Reduction	Behavioral: Mindfulness-Based Stress Reduction; The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.; Other Names: MBSR
Active Comparator: Health Enhancement Program Health Enhancement Program	Behavioral: Health Enhancement Program; The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.; Other Names: HEP

Outcome Measures

Primary Outcome Measures

1. Functional Neural Activation Parameter Estimate [baseline, 3 months]

   global maximum cluster-level neural activation during task-based functional magnetic resonance imaging for MBSR group compared to Health Enhancement Program group in a whole-brain analysis; paradigm: Emotional Faces N-Back; conditions: happy face distractors minus no face distractors; value has no minimum or maximum; value has no reference ranges; higher values indicate more neural activation

Other Outcome Measures

1. List Sorting Working Memory Test [baseline, 6 months]

   from National Institutes of Health (NIH) Toolbox; Age 7+ v2.1; measures working memory; T-score range 23-77; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better working memory performance; scores below 40 suggest cognitive impairment

2. Flanker Inhibitory Control and Attention Test [baseline, 6 months]

   from National Institutes of Health (NIH) Toolbox; Age 12+ v2.1; measures attention; T-score range 23-77; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better attention performance; scores below 40 suggest cognitive impairment

3. Cognitive Function [baseline, 3 months, 6 months]

   From the Quality of Life in Neurological Disorders (Neuro-QoL) Bank; v2.0; patient-reported outcome; measures executive function and general cognitive concerns; T-score range 17.3-64.2; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better self-reported cognitive function; scores 41-45 suggest mild cognitive impairment, 31-40 suggest moderate cognitive impairment, and 30 or below suggest severe cognitive impairment

4. Anxiety [baseline, 3 months, 6 months]

   From the Quality of Life in Neurological Disorders (Neuro-QoL) Bank; v1.0; patient reported outcome; T-score range 36.4-76.8; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse self-reported anxiety; scores 55-59 suggest mild anxiety, 60-69 suggest moderate anxiety, and 70 or above suggest severe anxiety

5. Depression [baseline, 3 months, 6 months]

   From the Quality of Life in Neurological Disorders (Neuro-QoL) Bank; v1.0; patient-reported outcome; measures depressive symptoms; T-score range 36.9-75.0; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse depressive symptoms; scores 55-59 suggest mild depressive symptoms, 60-69 suggest moderate depressive symptoms, and 70 or above suggest severe depressive symptoms

6. Gene Expression [baseline, 3 months, 6 months]

   AMIGO1 gene expression in raw gene counts for MBSR group compared to Health Enhancement Program group in a whole transcriptome analysis using ribonucleic acid sequencing (RNA-Seq); minimum 0, no maximum; value has no reference ranges; higher values indicate more gene expression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Female

2. <80 years of age by date of baseline assessment visit

3. Able to speak and read English

4. Post-menopausal (defined as [A] amenorrhea persisting for an entire year, [B] oophorectomy or ovarian suppression/ablation, or [C] hysterectomy and age >51 years)

5. Diagnosed with DCIS (stage 0) or stage I, II, or III breast cancer

6. Post lumpectomy or mastectomy and any re-excisions

7. Post neoadjuvant or adjuvant chemotherapy, if prescribed

8. Taking aromatase inhibitor (AI) therapy OR AI therapy scheduled to begin before planned post-intervention assessment visit

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer

2. Diagnosis of a major psychiatric disorder (e.g., bipolar I disorder, schizophrenia, schizoaffective disorder)

3. Suicide attempt within the last 10 years

4. Hospitalization or residential treatment for psychiatric illness, eating disorder, or substance abuse within the last 2 years

5. History of neurological disease (e.g., Parkinson's disease, dementia)

6. History of head trauma

7. Claustrophobia

8. Unable to lie on the back

9. Ever been told not to get an MRI

10. MRI-incompatible metal implant*

• If a potential participant reports implanted metal objects, which might be affected by MRI magnets, the study personnel and MRI technologist will screen over the phone or in person to determine whether the potential participant would be safe during the MRI scan. A current list of implants compatible with MRI will be consulted (http://www.mrisafety.com/TMDL_list.php).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University	New York	New York	United States	10010

Sponsors and Collaborators

• New York University
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: John D Merriman, PhD, RN, New York University Meyers College of Nursing

Study Documents (Full-Text)

• Study Protocol - Nov 16, 2021
• Statistical Analysis Plan - Aug 8, 2017
• Informed Consent Form - Aug 23, 2018

More Information

Publications

None provided.

• Responsible Party: John Merriman, Assistant Professor, New York University
• ClinicalTrials.gov Identifier: NCT03253627
• Other Study ID Numbers: s17-00995; 4R00NR015473-03
• First Posted: Aug 18, 2017
• Last Update Posted: May 19, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Neurobehavioral Manifestations

Study Results

Participant Flow

Recruitment Details	NYU was activated as a site in September 2017. Recruitment and screening began in January 2018. Enrollment started in April 2018 and ended in October 2019. Bellevue Hospital site approval was received in July 2019. Enrollment began then in its affiliated clinics and ended in October 2019.

Arm/Group Title	MBSR	Health Enhancement Program
Arm/Group Description	Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.	Health Enhancement Program Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.
Period Title: Overall Study
STARTED	12	11
Post-intervention	11	9
COMPLETED	10	7
NOT COMPLETED	2	4

Baseline Characteristics

Arm/Group Title	MBSR	Health Enhancement Program	Total
Arm/Group Description	Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.	Health Enhancement Program Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.	Total of all reporting groups
Overall Participants	12	11	23
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.9 (4.85)	55.6 (10.51)	61 (9.46)
Sex: Female, Male (Count of Participants)
Female	12 100%	11 100%	23 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 9.1%	1 4.3%
Not Hispanic or Latino	12 100%	10 90.9%	22 95.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 8.3%	0 0%	1 4.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 8.3%	1 9.1%	2 8.7%
White	10 83.3%	10 90.9%	20 87%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%	11 100%	23 100%

Outcome Measures

1. Primary Outcome

Title	Functional Neural Activation Parameter Estimate
Description	global maximum cluster-level neural activation during task-based functional magnetic resonance imaging for MBSR group compared to Health Enhancement Program group in a whole-brain analysis; paradigm: Emotional Faces N-Back; conditions: happy face distractors minus no face distractors; value has no minimum or maximum; value has no reference ranges; higher values indicate more neural activation
Time Frame	baseline, 3 months

Outcome Measure Data

Analysis Population Description

participants with usable neuroimaging data after quality control

Arm/Group Title	MBSR	Health Enhancement Program
Arm/Group Description	Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.	Health Enhancement Program Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.
Measure Participants	10	8
baseline	-1.2 (2.27)	-1.8 (2.28)
3 months	-0.8 (1.95)	-0.7 (2.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.460
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.896
	Comments
	Method	t-test, 2 sided
	Comments

2. Other Pre-specified Outcome

Title	List Sorting Working Memory Test
Description	from National Institutes of Health (NIH) Toolbox; Age 7+ v2.1; measures working memory; T-score range 23-77; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better working memory performance; scores below 40 suggest cognitive impairment
Time Frame	baseline, 6 months

Outcome Measure Data

Analysis Population Description

differences in sample size due to attrition

Arm/Group Title	MBSR	Health Enhancement Program
Arm/Group Description	Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.	Health Enhancement Program Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.
Measure Participants	12	11
baseline	48.7 (6.05)	51.5 (8.57)
6 months	50.5 (8.57)	56.3 (10.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.374
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.236
	Comments
	Method	t-test, 2 sided
	Comments

3. Other Pre-specified Outcome

Title	Flanker Inhibitory Control and Attention Test
Description	from National Institutes of Health (NIH) Toolbox; Age 12+ v2.1; measures attention; T-score range 23-77; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better attention performance; scores below 40 suggest cognitive impairment
Time Frame	baseline, 6 months

Outcome Measure Data

Analysis Population Description

Differences in sample size due to attrition

Arm/Group Title	MBSR	Health Enhancement Program
Arm/Group Description	Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.	Health Enhancement Program Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.
Measure Participants	12	11
baseline	46.5 (8.17)	41.9 (7.64)
6 months	43.3 (3.83)	42.4 (11.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.180
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.822
	Comments
	Method	t-test, 2 sided
	Comments

4. Other Pre-specified Outcome

Title	Cognitive Function
Description	From the Quality of Life in Neurological Disorders (Neuro-QoL) Bank; v2.0; patient-reported outcome; measures executive function and general cognitive concerns; T-score range 17.3-64.2; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better self-reported cognitive function; scores 41-45 suggest mild cognitive impairment, 31-40 suggest moderate cognitive impairment, and 30 or below suggest severe cognitive impairment
Time Frame	baseline, 3 months, 6 months

Outcome Measure Data

Analysis Population Description

Differences in sample size due to attrition

Arm/Group Title	MBSR	Health Enhancement Program
Arm/Group Description	Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.	Health Enhancement Program Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.
Measure Participants	12	11
baseline	47.0 (6.49)	45.9 (8.20)
3 months	45.4 (5.12)	46.0 (8.93)
6 months	47.4 (6.37)	46.4 (7.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.715
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.861
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.790
	Comments
	Method	t-test, 2 sided
	Comments

5. Other Pre-specified Outcome

Title	Anxiety
Description	From the Quality of Life in Neurological Disorders (Neuro-QoL) Bank; v1.0; patient reported outcome; T-score range 36.4-76.8; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse self-reported anxiety; scores 55-59 suggest mild anxiety, 60-69 suggest moderate anxiety, and 70 or above suggest severe anxiety
Time Frame	baseline, 3 months, 6 months

Outcome Measure Data

Analysis Population Description

Differences in sample size due to attrition

Arm/Group Title	MBSR	Health Enhancement Program
Arm/Group Description	Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.	Health Enhancement Program Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.
Measure Participants	12	11
baseline	51.3 (5.40)	53.1 (5.96)
3 months	48.8 (6.91)	53.9 (12.28)
6 months	46.7 (7.56)	50.3 (12.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.452
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.253
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.469
	Comments
	Method	t-test, 2 sided
	Comments

6. Other Pre-specified Outcome

Title	Depression
Description	From the Quality of Life in Neurological Disorders (Neuro-QoL) Bank; v1.0; patient-reported outcome; measures depressive symptoms; T-score range 36.9-75.0; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse depressive symptoms; scores 55-59 suggest mild depressive symptoms, 60-69 suggest moderate depressive symptoms, and 70 or above suggest severe depressive symptoms
Time Frame	baseline, 3 months, 6 months

Outcome Measure Data

Analysis Population Description

Differences in sample size due to attrition

Arm/Group Title	MBSR	Health Enhancement Program
Arm/Group Description	Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.	Health Enhancement Program Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.
Measure Participants	12	11
baseline	46.3 (6.31)	45.3 (3.24)
3 months	46.0 (6.78)	49.7 (10.41)
6 months	44.9 (7.24)	48.4 (8.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.628
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.345
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.384
	Comments
	Method	t-test, 2 sided
	Comments

7. Other Pre-specified Outcome

Title	Gene Expression
Description	AMIGO1 gene expression in raw gene counts for MBSR group compared to Health Enhancement Program group in a whole transcriptome analysis using ribonucleic acid sequencing (RNA-Seq); minimum 0, no maximum; value has no reference ranges; higher values indicate more gene expression
Time Frame	baseline, 3 months, 6 months

Outcome Measure Data

Analysis Population Description

participants with usable gene expression data after quality control

Arm/Group Title	MBSR	Health Enhancement Program
Arm/Group Description	Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.	Health Enhancement Program Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.
Measure Participants	9	9
baseline	106.1 (74.98)	137.3 (77.40)
3 months	196.0 (210.74)	176.3 (114.57)
6 months	114.4 (81.11)	218.3 (86.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.398
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	3 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.811
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MBSR, Health Enhancement Program
	Comments	6 months
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	For each participant, adverse event data were collected from the date of enrollment through the final assessment (i.e., approximately 6 months after enrollment).
Adverse Event Reporting Description	questionnaire at each follow-up assessment (i.e., post intervention, 3 months post intervention)
Arm/Group Title	MBSR		Health Enhancement Program
Arm/Group Description	Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction: The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.		Health Enhancement Program Health Enhancement Program: The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.
All Cause Mortality
	MBSR		Health Enhancement Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)
Serious Adverse Events
	MBSR		Health Enhancement Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	MBSR		Health Enhancement Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)

Limitations/Caveats

The sample was less than the anticipated final sample size of 32; it included fewer minority participants than planned. The advent of the COVID-19 pandemic prohibited further recruitment and conduct of this study, which had unavoidable in-person activities (e.g., neuroimaging).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.