Validating Spiritual Experience: A Pilot Study

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05485181
Collaborator
Damon House (Other), Rutgers Brain Health Institute (Other)
16
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2
9.9
1.6

Study Details

Study Description

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.

  1. 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.

  1. 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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Spiritual Intervention
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Validating Spiritual Experience: A Pilot Study
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

8 subjects get psychological assessments and fMRI brain scan followed by 9 week psychotherapeutic intervention. With intervention completion, psychological assessments and fMRI scan are repeated.

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.

Active Comparator: Cohort 2

8 subjects get psychological assessments at same time as Cohort 1, but do not receive the intervention at that time - serving as control group. When Cohort 1 is completed, Cohort 2 will repeat psychological assessments, receive fMRI scan, then receive same 9 week intervention as Cohort 1, followed by repeat psychological assessments and fMRI scan.

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.

Outcome Measures

Primary Outcome Measures

  1. NIH-HEALS [12 weeks]

    (NIH-Healing Experience of All Life Stressors) (Ameli et al, 2018): will show significant increase overall and in all 3 factors.NIH-HEALS A 35-item questionnaire, 3 factor structure:connection, reflection & introspection, trust & acceptance.

  2. fMRI Scan [12 weeks]

    fMRI Neuroimaging-will show reduced activity in MPFC, SPL, TPJ, and IPL

Secondary Outcome Measures

  1. Depression, Anxiety, Stress [12 weeks]

    DASS-21 (Depression, Anxiety, and Stress Scale) (Henry, 2005): will show significant decrease in depression, anxiety and overall stress on this 21-item questionnaire on a 0-3 scale with 3 factors- depression, anxiety, and stress

  2. Well-Being [12 weeks]

    WEMWBS (Warwick-Edinburgh Mental Wellbeing Scale) (Warwick, 2018) will show increase of greater than 3 points, considered "meaningful change on this 14-item questionnaire measures psychological well-being shown to be responsive to change.

  3. Transcendence [12 weeks]

    ASPIRES (Assessment of Spirituality and Religious Sentiments) (Piedmont, 2009):will show significant increase in transcendence, no change in religious sentiments on this 35-item questionnaire with 2 main factors- religious sentiments (RS) and spiritual transcendence (ST).

  4. Spiritual Independent Effects [12 weeks]

    NEO-FFI-3 (NEO-Five Factor Inventory) (McRae, 2007): will NOT account for relevant portion of outcome improvement on DASS-21, NIH-HEALS, and ASPIRES .This is a 60-item inventory of the FFM (Five Factor Model) of personality-with factors of neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.

  5. PTSD [12 weeks]

    PTSD Checklist for DSM-5(PCL-5) (Blevins, 2015): shows decrease 5-10 points (5 points=response, 10 points=clinically meaningful) on this 20-item questionnaire with 0-4 scale.

Other Outcome Measures

  1. Spirituality - Mysticism Measure [12 weeks]

    Mysticism Scale-Research Form D (Hood,1975): will show significant increase in measures that confirm the effects at a spiritual/mystical level. This is a 32-item self-report 5-point Likert-type scale measures established criteria for mystical experience with 8 factors.

  2. Theory Validity [12 weeks]

    Contingencies of Self-Worth Scale (Crocker, 2003): will show significant global increase that is positively correlated with increase in Mysticism Scale scores after spiritual intervention demonstrating their valid relationship. This is a 35-item self-report with a 1-7 scale that measures global self-worth with 7 factors.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Recently admitted 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 1 month.

Usual MRI Exclusionary Criteria detailed in IRB

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rutgers - The State University of New Jersey Piscataway New Jersey United States 08854

Sponsors and Collaborators

  • Rutgers, The State University of New Jersey
  • Damon House
  • Rutgers Brain Health Institute

Investigators

  • Principal Investigator: Kasia Bieszczad, PhD, Rutgers University - Dept Psychology
  • Principal Investigator: Nona Cooperman, PhD, Rutgers University - Dept Psychiatry

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
John Calvin Chatlos, MD, Medical Director SATS, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT05485181
Other Study ID Numbers:
  • Pro2022000889
First Posted:
Aug 3, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by John Calvin Chatlos, MD, Medical Director SATS, Rutgers, The State University of New Jersey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022