Validating Promoted Spiritual Experience

NCT05485181 | Completed

• 1 other identifier: Pro2022000889
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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. 1.Pilot a psychological intervention that impacts a "spiritual" level.
2. 2.Measure efficacy improving well-being beyond explanation by usual personality factors.
3. 3.Identify biological changes with neuroimaging.
4. 4.DASS-21-shows significant decrease in depression, anxiety and overall stress.
5. 5.PCL-5 - shows decrease 5-10 points (5 points=response, 10 points=clinically meaningful).
6. 6.NIH-HEALS - shows significant increase overall and in all 3 factors.
7. 7.WEMWBS - shows increase of greater than 3 points, considered "meaningful change."
8. 8.Contingencies of Self-Worth Scale-shows significant global increase, positively correlated with increase in Mysticism Scale scores with post-intervention total above standardized mean.
9. 9.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.
10. 10.ASPIRES-shows significant increase in transcendence, no change in religious sentiments.
11. 11.Neuroimaging-shows reduced activity in SPL, TPJ, MPFC, and IPL (see Research Significance).

Conditions

Addiction; Psychiatric Disorder

Keywords

spirituality; neuroimaging; CBT; self-worth; dignity

Outcome Measures

Primary Outcomes (2)

• NIH-HEALS

  (NIH-Healing Experience of All Life Stressors) (Ameli et al, 2018): 35-item Likert scale strongly disagree 1 to 5 strongly agree. 3 factor structure:connection (range 10-50), reflection (range 14-70 \& trust \& acceptance (range 11-55. Total range: 35-175. Higher score is better. Expected change in all 3 scales.

  12 weeks

• fMRI Scan

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

  12 weeks

Secondary Outcomes (5)

• Depression, Anxiety, Stress

  12 weeks

• Well-Being

  12 weeks

• Transcendence

  12 weeks

• Personally Independent Effects

  12 weeks

• PTSD

  12 weeks

Other Outcomes (4)

• Spirituality - Mysticism Measure

  12 weeks

• Theory Validity Self-Worth

  12 weeks

• NMI

  12 weeks

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Cohort 2

ACTIVE COMPARATOR

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

Interventions

Spiritual Intervention BEHAVIORAL

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.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No psychosis, no suicidal ideation or psychiatric hospitalization in past 3 months.

Sponsors & Collaborators

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

Study Sites (1)

Rutgers - The State University of New Jersey

Piscataway, New Jersey, 08854, United States

Location

Related Publications (1)

• 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.

  PMID: 29846531 BACKGROUND

Related Links

• Chatlos, J. Framework of Spirituality

MeSH Terms

Conditions

Behavior, Addictive; Mental Disorders

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Kasia Bieszczad, PhD

  Rutgers University - Dept Psychology

  PRINCIPAL INVESTIGATOR

• Nina Cooperman, PhD

  Rutgers University - Dept Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director SATS

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: January 20, 2023
• Primary Completion: July 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 3 months after published paper to 2 years.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)