StressNCT07325448
Assessing MB-Spirit for Psychological Well-being
A study testing MB-Spirit and Strong Behaviors for Stress Reduction in people with Stress, run by Sara W Lazar at 2 sites in United States.
Trial 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. Can the program decrease stress and improve spiritual well-being? 2. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- MB-Spirit and Strong Behaviors for Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understands English
- Able to attend all 8 classes
- Able to travel to Boston for MRI scans
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Staff contact
United States2 sites, 2 recruiting
- Recruiting
149 13th St
Boston, Massachusetts, 02129
Research Coordinator, 617-724-7108, slazar@mgh.harvard.edu
- Not yet recruiting
Charlestown Navy Yard Campus
Boston, Massachusetts, 02129
Sara Lazar, PhD, 6177247108, slazar@mgh.harvard.edu
About this study
Official title: Assessing MB-Spirit: A Novel Intervention for Promoting Spiritual Development and Psychological Well-being
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:
- Can the program decrease stress and improve spiritual well-being?
- What brain changes accompany participation in the programs?
Read more
Participants will:
- 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.
- Complete questionnaires before and after the course.
- Complete and interview before and after the course.
- A subset of people will be randomized to 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.
Read the detailed description
Forty-four individuals with high stress will be randomized 1:1, stratified by sex, to either the live or self-paced course. Participants will receive daily email with a link to a REDCap database to record minutes of homework practice. Pre and post testing will occur within a 21-day testing period before or after the courses. 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. A subset of participants will be randomized to 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 two 10-minute guided spiritual experience 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 states that arose. We will also assess the acceptability of the task.
- Conditions
- Stress
- Being tested
- MB-Spirit, Strong Behaviors for Stress Reduction
- Keywords
- stress, MRI, spirituality, well-being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-SpiritBehavioural
8-week online course that uses character strengths and mindfulness to promote well-being. Based on 3-part model of spirituality
Strong Behaviors for Stress ReductionBehavioural
Self-paced
| Study group | Role | What they receive |
|---|---|---|
| MB-Spirit | Experimental | 8-week online course that combines mindfulness with character strengths to promote well-being Receives: 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 Receives: Behavioral: Strong Behaviors for Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
Duke University Religion Index
Duke University Religion Index (DUREL) is a five-item measure to assess religiosity by examining three key dimensions: organizational religious activity (e.g., attending services), non-organizational religious activity (e.g., private prayer), and intrinsic religiosity (e.g., personal religious commitment and its influence on life). The overall scale has high test-retest reliability (intra-class correlation = 0.91), high internal consistence (Cronbach's alpha's = 0.78-0.91), high convergent validity with other measures of religiosity (r's = 0.71-0.86).
Measured: 8-weeks
Brief Signature Strengths Use Scale (BSSUS)
Brief Signature Strengths Use Scale (BSSUS) measures the extent to which participants recognize and use their signature character strengths. Five items are scored on a 7-point Likert scale, ranging from ranging from Strongly disagree to Very strongly agree. Higher scores indicate higher strength use.
Measured: 8 weeks
Metacognitive Processes of Decentering Scale (MPoD-t)
The Metacognitive Processes of Decentering Scale (MPoD-t) is a self-report scale developed to measure the ability to decenter, or separate one's sense of self from internal experiences, by assessing three core metacognitive processes: meta-awareness, (dis)identification with internal states, and (non)reactivity to thought content. The MPoD-t scales are used to study decentering, its role in mental health, and its potential as a therapeutic mechanism in mindfulness-based interventions
Measured: 8 weeks
PROMIS-29
The 29-item PROMIS-29 contains short assessments of eight core health domains including: anxiety, depression, physical function, sleep disturbance, pain interference and pain intensity, fatigue, and ability to participate in social roles and activities. Cronbach's α reliability for all domains range from 0.77 to 0.98 and scores remained stable over 18 months132 All domains use a 7-day recall period, except for PF and SRAA.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start15 Mar 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara W Lazar
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor-investigator, Sara W Lazar, Massachusetts General Hospital
- Investigators
- Sara Lazar, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325448
- Sponsor's protocol ID
- 2025A014112
- Status last verified
- Jun 2026
- First submitted
- 24 Dec 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing MB-Spirit: A Novel Intervention for Promoting Spiritual Development and Psychological Well-being
- ClinicalTrials.gov ID
- NCT07325448
- Acronym / sponsor ID
- 2025A014112
- Conditions
- Stress
- Keywords
- stress, MRI, spirituality, well-being
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sara W LazarUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can the program decrease stress and improve spiritual well-being?
- What brain changes accompany participation in the programs?
Participants will:
- 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.
- Complete questionnaires before and after the course.
- Complete and interview before and after the course.
- A subset of people will be randomized to 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 the live or self-paced course. Participants will receive daily email with a link to a REDCap database to record minutes of homework practice. Pre and post testing will occur within a 21-day testing period before or after the courses. 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. A subset of participants will be randomized to 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 two 10-minute guided spiritual experience 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 states that arose. We will also assess the acceptability of the task.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MB-Spirit | Experimental | Behavioral: MB-Spirit8-week online course that combines mindfulness with character strengths to promote well-being |
| Strong Behaviors for Stress Reduction | Active comparator | Behavioral: Strong Behaviors for Stress Reductionself-paced program. Participants receive materials once a week to complete at their own pace |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Understands English
- Able to attend all 8 classes
- Able to travel to Boston for MRI scans
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB-Spirit8-week online course that uses character strengths and mindfulness to promote well-being. Based on 3-part model of spirituality | Behavioural | MB-Spirit |
| Strong Behaviors for Stress ReductionSelf-paced | Behavioural | Strong Behaviors for Stress Reduction |
Primary outcome
FACIT-SP meaning and peace subscale
Time frame: 8 weeks
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.
4 secondary outcomes
Duke University Religion Index
Time frame: 8-weeks
Brief Signature Strengths Use Scale (BSSUS)
Time frame: 8 weeks
Metacognitive Processes of Decentering Scale (MPoD-t)
Time frame: 8 weeks
PROMIS-29
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Staff contact
Sara Lazar, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MB-Spirit and Strong Behaviors for Stress Reduction in people with Stress, run by Sara W Lazar at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Staff (617-415-8813, slazar@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACIT-SP meaning and peace subscale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.