Validating Promoted Spiritual Experience

Addiction Clinical Trial

Official title: Validating Promoted Spiritual Experience: A Pilot Study

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Addiction
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

• NCT number: NCT05485181
• Study type: Interventional
• Source: Rutgers, The State University of New Jersey
• Status: Completed
• Phase: N/A
• Start date: January 20, 2023
• Completion date: October 1, 2023