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| Name | Class |
|---|---|
| Damon House | UNKNOWN |
| Rutgers Brain Health Institute | UNKNOWN |
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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
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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Well-Being |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kasia Bieszczad, PhD | Rutgers University - Dept Psychology | Principal Investigator |
| Nina Cooperman, PhD | Rutgers University - Dept Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers - The State University of New Jersey | Piscataway | New Jersey | 08854 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29846531 | Background | 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. |
| Label | URL |
|---|---|
| Chatlos, J. Framework of Spirituality | View source |
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Individual data that underlie the results of the study after de-identification.
3 months after published paper to 2 years.
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
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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.
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |