Assessing MB-Spirit for Psychological Well-being

NCT ID: NCT07325448

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-10
• Study Completion Date: 2026-11-30

Brief Summary

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:

1. Can MB-Spirit improve well-being?

2. What brain changes accompany participation in MB-Spirit?

Participants will:

1. Be enrolled in an online course that meets for two hours every week for 8-weeks.

2. Complete questionnaires before and after the course.

3. 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.

Detailed 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.

Conditions

Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

MB-Spirit

8-week online course that combines mindfulness with character strengths to promote well-being

Group Type: EXPERIMENTAL

MB-Spirit

Intervention Type: BEHAVIORAL

8-week online course that uses character strengths and mindfulness to promote well-being. Based on 3-part model of spirituality

Wait-list

Wait list

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MB-Spirit

8-week online course that uses character strengths and mindfulness to promote well-being. Based on 3-part model of spirituality

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Sara W Lazar

OTHER

Sponsor Role: lead

Responsible Party

Sara W Lazar

Associate Research Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sara Lazar, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Charlestown Navy Yard Campus

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Sara Lazar, PhD

Role: CONTACT

slazar@mgh.harvard.edu

617-724-7108

Facility Contacts

Sara Lazar, PhD

Role: primary

slazar@mgh.harvard.edu

6177247108

Other Identifiers

2025A014112

Identifier Type: -

Identifier Source: org_study_id