Validating Promoted Spiritual Experience

Addiction Clinical Trial

Official title:

Validating Promoted Spiritual Experience: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05485181
• Other study ID #: Pro2022000889
• Status: Completed
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: April 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Rutgers - The State University of New Jersey	Piscataway	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Damon House, Rutgers Brain Health Institute

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spirituality - Mysticism Measure	Mysticism Scale-Research Form D (Hood,1975): 32-item Likert scale 5-point Strongly Agree to Strongly Disagree. Range: 32-160 toal. Eight factors: ego quality, unifying quality, inner subjective quality, temporal/spatial quality, noetic auality, positive affect, religious quality. Expected outcome is a change in all factors.	12 weeks
Other	Theory Validity Self-Worth	Contingencies of Self-Worth Scale (Crocker, 2003): 35-item Likert scale Strongly Agree 1 to 7 Strongly Disagree, higher is better. Measures global self-worth (Range: 30-210) and 6 factors (Range:5-35) with 6 factors. Expected outcome is change in global self-worth total.	12 weeks
Other	NMI	Numinous Motivation Inventory (Piedmont 2017) 22-item Likert scale Strongly Disagree 1 to 5 Strongly Agree, Range: 22-110, higher is better. Expected outcome is change of total score.	12 weeks
Other	Human Spirituality Scale	HHS (Wheat 1991) 21-item Likert scale 5 point, end ponts vary. Range: 21-105, lower is greater. Expected outcome is change of total score.	12 weeks
Primary	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
Primary	fMRI Scan	fMRI Neuroimaging-will show change in activity in MPFC, SPL, TPJ, and IPL	12 weeks
Secondary	Depression, Anxiety, Stress	DASS-21 (Depression, Anxiety, and Stress Scale) (Henry, 2005): 21-item Likert scale Never 0 to 3 Almost always, lower is better. Range each scale: 0-21. Expected change in depression, anxiety and overall stress scales.	12 weeks
Secondary	Well-Being	WEMWBS (Warwick-Edinburgh Mental Wellbeing Scale) (Warwick, 2018) measures psychological well-being; 14-item Likert scale None of the time 1 to 5 All of the time. Range: 14-70, higher is better. Expected change in overall score.	12 weeks
Secondary	Transcendence	ASPIRES (Assessment of Spirituality and Religious Sentiments) (Piedmont, 2009): 35-item Likert scale strongly agree 1 to 5 strongly disagree. 2 main factors- religious sentiments (RS) (Range 12-60) and spiritual transcendence(ST) (Range:23-115) . Expected outcome is change in ST scale only.	12 weeks
Secondary	Personally Independent Effects	NEO-FFI-3 (NEO-Five Factor Inventory) (McRae, 2007): 60-item yes/no response FFM (Five Factor Model) of personality- Neuroticism, Extraversion, Openness to experience, Agreeableness, and Conscientiousness.Range: 0-12, higher is greater. No expected change, used for comparison.	12 weeks
Secondary	PTSD	PTSD Checklist for DSM-5(PCL-5) (Blevins, 2015): 20-item Likert scale Not at all 0 to 4 Extremely. Range: 14-70, lower is better. Expected outcome is change in overall score.	12 weeks