Trial Outcomes & Findings for Meditation Effects on Brain Function in Rheumatoid Arthritis (NCT NCT03975595)

NCT ID: NCT03975595

Last Updated: 2023-03-09

Results Overview

Activation in the Lateral Orbital Frontal Cortex will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention A in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes.
• Results posted on: 2023-03-09

Participant Flow

Participant milestones

Measure	Meditation Group A-Savoring A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Intervention A: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding. Participants in the Savoring Meditation Condition were trained to generate positive emotions through savoring a positive autobiographical memory in a multi-sensory manner.	Meditation Group B-Breathing A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Intervention B: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding. Participants in the Breathing Meditation condition were trained to relax the body and take deep breaths in a self-directed manner.
Overall Study STARTED	21	23
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	6	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Meditation Effects on Brain Function in Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Meditation Group A n=21 Participants A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Group A is the Savoring Meditation Condition. Participants in this condition were trained to generate positive emotions through savoring a pleasant autobiographical memory in a multi-sensory manner. Meditation Intervention A: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.	Meditation Group B n=23 Participants A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Group B is the Breathing Meditation Condition. Participants in this condition were trained to relax and body and take deep breaths in a self-directed manner. Meditation Intervention B: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.	Total n=44 Participants Total of all reporting groups
Age, Continuous	50.7 years STANDARD_DEVIATION 12.0 • n=93 Participants	49.8 years STANDARD_DEVIATION 10.9 • n=4 Participants	50.2 years STANDARD_DEVIATION 11.3 • n=27 Participants
Sex: Female, Male Female	20 Participants n=93 Participants	21 Participants n=4 Participants	41 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Race · Black or African American	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Race/Ethnicity, Customized Race · White or European American	13 Participants n=93 Participants	13 Participants n=4 Participants	26 Participants n=27 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment United States	21 Participants n=93 Participants	23 Participants n=4 Participants	44 Participants n=27 Participants

PRIMARY outcome

Timeframe: Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes.

Population: This outcome was not assessed because it was intended for comparison with a treatment arm (mindful breathing) that was dropped from the study due to COVID-19 delays. No data was collected.

Activation in the Lateral Orbital Frontal Cortex will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention A in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes

Activation in the Nucleus Accumbens will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention B in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute (ml/100g/min). There is no normal range for this measure.

Outcome measures

Measure	Meditation Group A n=15 Participants A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Intervention A: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.	Meditation Group B n=14 Participants A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding). Meditation Intervention B: This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.
Nucleus Accumbens Activation	16153.59 ml/100g/min Standard Deviation 1309.90	15834.56 ml/100g/min Standard Deviation 1681.54

Adverse Events

Meditation Group A-Savoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Meditation Group B-Breathing

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

Dr. Patrick Finan

University of Virginia

Phone: (720) 244-1702

Email: tpx4xe@virginia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place