Clinical trial NCT05485181: Validating Promoted Spiritual Experience
Official title: Validating Promoted Spiritual Experience: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Addiction
Psychiatric Disorder
Keywords: spirituality
neuroimaging
CBT
self-worth
dignity
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Damon House
name: Rutgers Brain Health Institute
First posted: 2022-08-03
Enrollment: 16
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Two cohorts of 8 subjects each will receive psychological assessments initially.

First cohort will have brain scan followed by 9 week intervention and post-intervention repeat scan and repeat assessments.

2nd cohort serves as its own control, will receive repeat assessments and brain scan after Cohort 1 is done, and again after 9 week intervention.
Primary purpose: TREATMENT

Brief 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).

Detailed description: Following IRB approval, recruit 16 patients from a male residential addiction treatment program for a 10-session intervention. 8 subjects will be given pre and post intervention psychological assessments and pre and post fMRIs. Another 8 subjects will serve as a control group and will receive the pre and post (without intervention) psychological assessments at the same time as the previous group and will then be the next 8 subjects to receive the intervention after completion of the first cohort. They will have MRIs before their intervention and post-intervention, thus serving as their own control group. The behavioral intervention occurs with a beginning 3 hour group introduction done by Dr. Chatlos followed by 9 weekly 1 ½ hour group sessions. The subjects' intervention will be recorded for further manual development.

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.

Eligibility criteria: Inclusion Criteria:

* Recently admitted (within 3 months) male patients of a residential addiction treatment program that has a 6 month average duration.
* Age 21 or older.
* Volunteer for the study after a brief introduction.

Exclusion Criteria:

* No psychosis, no suicidal ideation or psychiatric hospitalization in past 3 months.
* Usual MRI Exclusionary Criteria detailed in IRB

Primary outcomes:
measure: NIH-HEALS
timeFrame: 12 weeks
measure: fMRI Scan
timeFrame: 12 weeks
Secondary outcomes:
measure: Depression, Anxiety, Stress
timeFrame: 12 weeks
measure: Well-Being
timeFrame: 12 weeks
measure: Transcendence
timeFrame: 12 weeks
measure: Personally Independent Effects
timeFrame: 12 weeks
measure: PTSD
timeFrame: 12 weeks
Other outcomes:
measure: Spirituality - Mysticism Measure
timeFrame: 12 weeks
measure: Theory Validity Self-Worth
timeFrame: 12 weeks
measure: NMI
timeFrame: 12 weeks
measure: Human Spirituality Scale
timeFrame: 12 weeks
Locations:
city: Piscataway
country: United States
facility: Rutgers - The State University of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers University - Dept Psychology
name: Kasia Bieszczad, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University - Dept Psychiatry
name: Nina Cooperman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller L, Balodis IM, McClintock CH, Xu J, Lacadie CM, Sinha R, Potenza MN. Neural Correlates of Personalized Spiritual Experiences. Cereb Cortex. 2019 Jun 1;29(6):2331-2338. doi: 10.1093/cercor/bhy102.