Health TrialsbyHealthPanel

Assessing MB-Spirit for Psychological Well-being

ConditionStress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorSara W Lazar

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Understands English

Able to attend all 8 classes

Able to travel to Boston for MRI scans

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • MB-Spirit

    Behavioral

    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 Reduction

    Behavioral

    Self-paced

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: MB-SpiritExperimental treatment 1 intervention
Group B: Strong Behaviors for Stress ReductionActive comparator 1 intervention

Trial outcomes

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.

Time frame
8 weeks

Secondary outcomes

1

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).

Time frame
8-weeks
2

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.

Time frame
8 weeks
3

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

Time frame
8 weeks
4

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.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sara W Lazar

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Harvard Medical School (HMS and HSDM)

Collaborator

Source ClinicalTrials.gov
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