Assessing MB-Spirit for Psychological Well-being

Sara W Lazar

Status

Not yet enrolling

Conditions

Stress

Treatments

Behavioral: MB-Spirit

Study type

Interventional

Funder types

Other

Identifiers

NCT07325448

2025A014112

Details and patient eligibility

About

The goal of this clinical trial is to learn if a new behavioral intervention, MB-Spirit, can improve well-being in stressed adults. The main questions it aims to answer are:

Can MB-Spirit improve well-being?
What brain changes accompany participation in MB-Spirit?

Participants will:

Be enrolled in an online course that meets for two hours every week for 8-weeks.
Complete questionnaires before and after the course.
Complete an MRI scan of their brain before and after the course.

Participants will be randomized to either take the course right away, or be put on a wait-list. Those on the wait-list will undergo the testing at 2 timepoints before they start the program.

Full description

Forty-four individuals with high stress will be randomized 1:1, stratified by sex, to either MB-SPIRIT or wait-list. Participants will receive daily email with a link to a REDCap database to record minutes of formal meditation practice. Pre and post testing will occur within a 21-day testing period before or after the intervention. We will assess changes in spiritual well-being (Primary outcome), mindfulness, and use of character/virtue strengths (secondary outcomes). Changes in clinical symptoms will be explored. Participants will also complete a structured interview to assess developmental stage at the baseline time-point. Participants randomized to MB-Spirit will also undergo functional magnetic resonance imaging (fMRI) scanning before and after their program. Scans consist of a high-resolution gray matter scan, a 10-minute resting state scan and three 10-minute guided meditation scans. Participants will rate the 'depth' of each spiritual state they experience while they are in the scanner on a 5-point scale. As a manipulation check, after exiting the scanner they will be asked to describe the non-dual states and which virtues arose. We will also assess the acceptability of the task.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Understands English
Able to attend all 8 classes
Able to travel to Boston for MRI scans

Exclusion criteria

claustrophobia, pregnancy, head trauma, metallic implants or devices contraindicating MRI, left-handed, conditions that alter cerebral blood flow or metabolism (e.g. stroke), current use of psychotropic medications, lifetime history of suicidality, homicidally, self-destructive acts, schizophrenia or psychosis.