Cognitive Function and Affective Regulation in Meditators (CALM)

This is a prospective cohort study with 52 meditators and 52 controls. These groups will be contacted at a singular timepoint, during which they will take surveys and cognitive tests, which will be used to assess cognitive and emotional outcomes. The meditator group will be recruited from a pool of healthy individuals who have learned meditation practices such as those taught by the Isha Foundation (e.g., Shambhavi Mahamudra Kriya, Shoonya, Samyama breath-watching, etc.) Meditation-naïve individuals will be recruited into the control group.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Function and Affective Regulation

Detailed Description

This is a prospective cohort study with 52 meditators and 52 controls. These groups will be contacted at a singular timepoint, during which they will take surveys and cognitive tests, which will be used to assess cognitive and emotional outcomes. The meditator group will be recruited from a pool of healthy individuals who have learned meditation practices such as those taught by the Isha Foundation (e.g., Shambhavi Mahamudra Kriya, Shoonya, Samyama breath-watching, etc.) Meditation-naïve individuals will be recruited into the control group. Despite allocation to 2 separate cohorts, both groups will be subjected to identical questionnaires and tasks at the singular timepoint. Further, none of the above practices are being taught by the study team. Rather, the investigators are only looking to study the effects of the aforementioned practices on participants through validated survey questionnaires and cognitive tasks.

Study Procedure: Following e-consent and enrollment into the study, participants are asked to complete electronic surveys and cognitive tasks. These will either be completed virtually on the participants' own device or on a BIDMC-approved device brought to the participant by the study team. (Further details on the remote administration of surveys and cognitive tasks explained below)

Questionnaire: The following questionnaires are incorporated into the study and will be administered to the study participants at a single timepoint.

Demographic, medical history, past meditation experience, and habits: Collects demographic details (age, ethnicity, gender, education/employment, marital status, number of children, country of residence), meditation exposure and duration of practice, past cognitive training, alcohol use, and smoking.

Cognitive Emotional Regulation Questionnaire (CERQ): This survey aims to collect information on a person's thoughts after having experienced a negative event.

Positive And Negative Affect Schedule (PANAS): Comprises two mood scales measuring positive affect and negative affect. Participants respond to a 20-item test using a 5-point scale that ranges from very slightly or not at all (1) to extremely (5). Scores can range from 10-50 for both the Positive and Negative affect with lower scores representing lower levels of affect and higher scores representing higher levels of affect.

Four-Item Patient Health Questionnaires (PHQ-4) for Anxiety & Depression: Assesses anxiety and depression. Scores range from 0-12 with subscales for anxiety (items 1-2) and depression (items 3-4); scores greater than 3 on each subscale are considered positive.

Perceived Stress Scale (PSS): 10-question validated instrument that assesses stress. Participants are asked to rate on a scale of 0 (never) to 4 (very often) how often they agree with various statements. Items from each of the 10 questions are then summed to create a total perceived stress score. Please see the survey details in the attached "Study Questionnaire" attachment.

Cognitive Tasks: Participants will be asked to complete a set of cognitive tasks to assess executive function, attention, memory, and affect regulation. The tasks would require participants to respond in a specific manner to certain stimuli based on the instructions appearing on the screen. The tasks may also contain images with positive or negative emotional content. Some examples of the tasks that may be used in this study are provided below.

Multi-Source Interference Task (MSIT): Participants are presented with a sequence of three numbers in each trial and are asked to identify and press the key corresponding to the number that is not repeated. In "congruent" trials, the target number appears in the spot corresponding to its value and is flanked by zeros (e.g., "0 2 0"). In "incongruent" trials, the target number is in a spot that does not correspond to its value and is flanked by a non-zero digit (e.g., "3 3 2"). Images with positive, negative, or neutral emotional content are presented simultaneously with the number sequences to test emotional regulation.

N-back Task: Participants are presented with a sequence of letters. Participants are given two keys they can respond with. They are asked to press one key if the current letter is the same as the letter that was presented n letters back, and press the other key if the current letter does not match the letter that was presented n letters back.

These cognitive tasks will be either administered remotely through a secure online cognitive task hosting platform such as Pavlovia (pavlovia.org). Participants will be provided the link to the task on the online platform, and will only be asked to enter their de-identified study ID (e.g., CALM01, CALM02). This link will be unique to the study and will be generated and sent to participants once they enroll in the study.

• Study Type: Observational
• Enrollment (Estimated): 104

Contacts and Locations

• Study Contact: Name: Balachundhar Subramaniam, MD MPH; Phone Number: (781) 472-0572; Email: bsubrama@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • BIDMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects will not be recruited based on race, ethnicity, or gender. However, it is not clear whether the final study sample will contain a representative spread of the racial and gender makeup. There is no reason to exclude pregnant women from this protocol.

Description

Inclusion Criteria:

• Participants must be able to read and understand English.
• Meditators: Participants must regularly practice meditation (4 or more times per week).
• Controls: Participants must not regularly practice meditation (4 or more times per week)

Exclusion Criteria:

• Below the age of 18.
• Participants not living in the US.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Meditators; Participants who regularly practice meditation (4 or more times per week)
Controls; Participants who do not regularly practice meditation (4 or more times per week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multi-Source Interference Task (MSIT)	Participants are presented with a sequence of three numbers in each trial and are asked to identify and press the key corresponding to the number that is not repeated. In "congruent" trials, the target number appears in the spot corresponding to its value and is flanked by zeros (e.g., "0 2 0"). In "incongruent" trials, the target number is in a spot that does not correspond to its value and is flanked by a non-zero digit (e.g., "3 3 2"). Images with positive, negative, or neutral emotional content are presented simultaneously with the number sequences to test emotional regulation.	within one week of consent
N-back Task	Participants are presented with a sequence of letters. Participants are given two keys they can respond with. They are asked to press one key if the current letter is the same as the letter that was presented n letters back, and press the other key if the current letter does not match the letter that was presented n letters back.	within one week of consent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Emotional Regulation Questionnaire (CERQ)	This survey aims to collect information on a person's thoughts after having experienced a negative event. Comprised of 36-items, with scores from 1 (never) to 5 (always), total subscale scores range from 4 to 20. Higher subscale scores indicate increased frequency of use for the specified regulation strategy.	within one week of consent
Positive And Negative Affect Schedule (PANAS)	Comprises two mood scales measuring positive affect and negative affect. Participants respond to a 20-item test using a 5-point scale that ranges from very slightly or not at all (1) to extremely (5). Total sScores can range from 10-50 for both the Positive and Negative affect with lower scores representing lower levels of affect and higher scores representing higher levels of affect.	within one week of consent
Four-Item Patient Health Questionnaires (PHQ-4) for Anxiety & Depression	Total scores range from 0-12 with subscales for anxiety (items 1-2) and depression (items 3-4); scores greater than 3 on each subscale are considered positive. Higher scores indicate increased anxiety/depression symptoms.	within one week of consent
Perceived Stress Scale (PSS)	10-question validated instrument that assesses stress. Participants are asked to rate on a scale of 0 (never) to 4 (very often) how often they agree with various statements. Items from each of the 10 questions are then summed to create a total perceived stress score, with a minimum score of 0 and maximum score of 40. Higher scores indicate a higher level or perceived stress.	within one week of consent

Collaborators and Investigators

• Sponsor: Balachundhar Subramaniam

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive Function
• Other Study ID Numbers: 2023P000588

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No