NCT07325448

Brief Summary

The goal of this clinical trial is to test two new behavioral interventions designed to reduce stress and improve spiritual well-being in stressed adults. The main questions it aims to answer are:

  1. 1.Can the program decrease stress and improve spiritual well-being?
  2. 2.What brain changes accompany participation in the programs?
  3. 3.Be randomized to either a live online course that meets for 90 minutes every week for 8-weeks, or to a self-paced program. In the self-paced program, participants will receive materials once a week and can work through them at their own pace. Both programs are designed to decrease stress and improve well-being.
  4. 4.Complete questionnaires before and after the course.
  5. 5.Complete and interview before and after the course.
  6. 6.A subset of people will be randomized to complete an MRI scan of their brain before and after the course.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Mar 2026Nov 2026

First Submitted

Initial submission to the registry

December 24, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

December 24, 2025

Last Update Submit

June 9, 2026

Conditions

Stress

Keywords

stressMRIspiritualitywell-being

Outcome Measures

Primary Outcomes (1)

  • FACIT-SP meaning and peace subscale

    The meaning and peace subscale of the widely used and well-validated FACIT-SP-non-illness (Functional assessment of chronic illness therapy spiritual wellbeing - non illness) is our primary outcome metric. It has very good reliability (alpha=.81) and has high discriminate validity.

    8 weeks

Secondary Outcomes (4)

  • Duke University Religion Index

    8-weeks

  • Brief Signature Strengths Use Scale (BSSUS)

    8 weeks

  • Metacognitive Processes of Decentering Scale (MPoD-t)

    8 weeks

  • PROMIS-29

    8 weeks

Study Arms (2)

MB-Spirit

EXPERIMENTAL

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

Behavioral: MB-Spirit

Strong Behaviors for Stress Reduction

ACTIVE COMPARATOR

self-paced program. Participants receive materials once a week to complete at their own pace

Behavioral: Strong Behaviors for Stress Reduction

Interventions

Strong Behaviors for Stress ReductionBEHAVIORAL

Self-paced

Strong Behaviors for Stress Reduction
MB-SpiritBEHAVIORAL

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

MB-Spirit

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

149 13th St

Boston, Massachusetts, 02129, United States

RECRUITING

Charlestown Navy Yard Campus

Boston, Massachusetts, 02129, United States

NOT YET RECRUITING

Study Officials

  • Sara Lazar, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Staff

CONTACT

617-415-8813slazar@mgh.harvard.edu

Staff

CONTACT

stressreduction@partners.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Research Scientist

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 8, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Only de-identified data will be shared with other researchers. We are collaborating with an investigator at the University of Vienna who will have access to all de-identified data.

Time Frame
The brain and self-report data and meta-data will be deposited in the ENIGMA-Meditation data repository hosted at Ohio State University within 6 months of the first paper being accepted for publication. There are no plans to remove the data from the repository.
Access Criteria
No identifiable information will be included in the dataset. Any researcher interested in accessing the data must first contact the study PI and request permission. The study PI then needs to obtain IRB approval for any additional analyses that will be performed.

Locations

US(2)