Assessing MB-Spirit for Psychological Well-being

Официальное название

Assessing MB-Spirit: A Novel Intervention for Promoting Spiritual Development and Psychological Well-being

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое MB-Spirit
  8-week online course that uses character strengths and mindfulness to promote well-being. Based on 3-part model of spirituality
• Поведенческое Strong Behaviors for Stress Reduction
  Self-paced

Первичные конечные точки

• FACIT-SP meaning and peace subscale [Срок оценки: 8 weeks]

Вторичные конечные точки (4)

• Duke University Religion Index [Срок оценки: 8-weeks]
• Brief Signature Strengths Use Scale (BSSUS) [Срок оценки: 8 weeks]
• Metacognitive Processes of Decentering Scale (MPoD-t) [Срок оценки: 8 weeks]
• PROMIS-29 [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 2 центра

• 149 13th St — Boston
• Charlestown Navy Yard Campus — Boston

Идентификаторы

NCT: NCT07325448 · 2025A014112

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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