Validating Promoted Spiritual Experience

Rutgers The State University of New Jersey

Status: Completed

Conditions: Psychiatric Disorder; Addiction

Treatments: Behavioral: Spiritual Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05485181

Pro2022000889

Details and patient eligibility

About

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).

Full 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.

Enrollment: 16 patients

Sex: Male

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Behavioral: Spiritual Intervention

Cohort 2

Active Comparator group

Description:

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.

Treatment:

Behavioral: Spiritual Intervention