Validating Promoted Spiritual Experience
NCT05485181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2024-04-17
Summary
This pilot study of 16 patients will demonstrate a specific psychologically focused intervention to affect a spiritual aspect of psychological health and will measure (1) its effects on general distress, depression, anxiety and well-being; (2) healing and psychological impact beyond that accounted by usual personality factors; (3) its effect in correlation to measures of spirituality; (4) with neuroimaging, possible biological changes associated with this intervention.
A. Objectives
1. Pilot a psychological intervention that impacts a "spiritual" level.
2. Measure efficacy improving well-being beyond explanation by usual personality factors.
3. Identify biological changes with neuroimaging.
B. Hypotheses / Research Question(s) Studies demonstrate a healing effect beyond usual psychological and medical health to include a "spiritual" aspect with added experience of wholeness and well-being. Benefits are beyond just symptom relief but methods to achieve this are not well-defined. This study will provide a specific intervention and measure psychological and neuroimaging effects of the intervention.
Hypotheses of Specific Results (see Study Instruments below)
1. DASS-21-shows significant decrease in depression, anxiety and overall stress.
2. PCL-5 - shows decrease 5-10 points (5 points=response, 10 points=clinically meaningful).
3. NIH-HEALS - shows significant increase overall and in all 3 factors.
4. WEMWBS - shows increase of greater than 3 points, considered "meaningful change."
5. Contingencies of Self-Worth Scale-shows significant global increase, positively correlated with increase in Mysticism Scale scores with post-intervention total above standardized mean.
6. A relevant portion of outcome improvement on DASS-21, NIH-HEALS, and ASPIRES will NOT be accountable by personality factors measured by NEO-FFI-3.
7. ASPIRES-shows significant increase in transcendence, no change in religious sentiments.
8. Neuroimaging-shows reduced activity in SPL, TPJ, MPFC, and IPL (see Research Significance).
Conditions
- Addiction
- Psychiatric Disorder
Interventions
- BEHAVIORAL
-
Spiritual Intervention
The Intervention is a CBT- based psychotherapeutic process that occurs in a group setting with two cohorts of 8 subjects each. It will occur in an introductory 3-hour session followed by 9 weekly 1 ½ hour sessions. In this process, self-worth (self-confidence, self-esteem, self-competence) and dignity (reason, compassion, courage) as operationally defined are strengthened through an interpersonal, psychological process including mindful self-awareness training, attitude transformation with self-compassion, forgiveness, and self-acceptance, and opens to a new level of awareness. This awareness opens to spiritual / numinous features of connectedness, vitality, wholeness, meaning, and serenity that are predicted to be associated with greater well-being and relief of anxiety and depression symptoms.
Sponsors & Collaborators
-
Damon House
collaborator UNKNOWN -
Rutgers Brain Health Institute
collaborator UNKNOWN -
Rutgers, The State University of New Jersey
lead OTHER
Principal Investigators
-
Kasia Bieszczad, PhD · Rutgers University - Dept Psychology
-
Nina Cooperman, PhD · Rutgers University - Dept Psychiatry
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 21 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-01-20
- Primary Completion
- 2023-07-01
- Completion
- 2023-10-01
Countries
- United States
Study Locations
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