Assessing MB-Spirit for Psychological Well-being
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MB-Spirit, Strong Behaviors for Stress Reduction.
- Who it may be relevant to
- Registry conditions: Stress. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing MB-Spirit: A Novel Intervention for Promoting Spiritual Development and Psychological Well-being
Overview
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. What brain changes accompany participation in the programs? Participants will: 1. 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. 2. Complete questionnaires before and after the course. 3. Complete and interview before and after the course. 4. 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.
Interventions
- Behavioral MB-Spirit
8-week online course that uses character strengths and mindfulness to promote well-being. Based on 3-part model of spirituality - Behavioral Strong Behaviors for Stress Reduction
Self-paced
Primary outcome measures
- FACIT-SP meaning and peace subscale [Time frame: 8 weeks]
Secondary outcome measures (4)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 2 centers
- 149 13th St — Boston
- Charlestown Navy Yard Campus — Boston
Identifiers
NCT: NCT07325448 · 2025A014112