Validating Promoted Spiritual Experience
- Conditions
- AddictionPsychiatric Disorder
- Interventions
- Behavioral: Spiritual Intervention
- Registration Number
- NCT05485181
- Lead Sponsor
- Rutgers, The State University of New Jersey
- 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. 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
- 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.
- No psychosis, no suicidal ideation or psychiatric hospitalization in past 3 months.
- Usual MRI Exclusionary Criteria detailed in IRB
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 Spiritual Intervention 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. Cohort 2 Spiritual Intervention 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.
- Primary Outcome Measures
Name Time Method NIH-HEALS 12 weeks (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.
fMRI Scan 12 weeks fMRI Neuroimaging-will show change in activity in MPFC, SPL, TPJ, and IPL
- Secondary Outcome Measures
Name Time Method Transcendence 12 weeks 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.
Depression, Anxiety, Stress 12 weeks 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.
Well-Being 12 weeks 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.
Personally Independent Effects 12 weeks 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.
PTSD 12 weeks 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.
Trial Locations
- Locations (1)
Rutgers - The State University of New Jersey
🇺🇸Piscataway, New Jersey, United States