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| Name | Class |
|---|---|
| Harvard Medical School (HMS and HSDM) | OTHER |
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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:
Participants will:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MB-Spirit | Experimental | 8-week online course that combines mindfulness with character strengths to promote well-being |
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| Strong Behaviors for Stress Reduction | Active Comparator | self-paced program. Participants receive materials once a week to complete at their own pace |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MB-Spirit | Behavioral | 8-week online course that uses character strengths and mindfulness to promote well-being. Based on 3-part model of spirituality |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Staff | Contact | 617-415-8813 | slazar@mgh.harvard.edu | |
| Staff | Contact | stressreduction@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Sara Lazar, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 149 13th St | Recruiting | Boston | Massachusetts | 02129 | United States |
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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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.
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.
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| Strong Behaviors for Stress Reduction | Behavioral | Self-paced |
|
| 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. | 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 | 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. | 8 weeks |
| Charlestown Navy Yard Campus | Not yet recruiting | Boston | Massachusetts | 02129 | United States |
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