Validating Promoted Spiritual Experience: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- NIH-HEALS
研究概览
简要总结
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
- Pilot a psychological intervention that impacts a "spiritual" level.
- Measure efficacy improving well-being beyond explanation by usual personality factors.
- 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)
- DASS-21-shows significant decrease in depression, anxiety and overall stress.
- PCL-5 - shows decrease 5-10 points (5 points=response, 10 points=clinically meaningful).
- NIH-HEALS - shows significant increase overall and in all 3 factors.
- WEMWBS - shows increase of greater than 3 points, considered "meaningful change."
- Contingencies of Self-Worth Scale-shows significant global increase, positively correlated with increase in Mysticism Scale scores with post-intervention total above standardized mean.
- 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.
- ASPIRES-shows significant increase in transcendence, no change in religious sentiments.
- Neuroimaging-shows reduced activity in SPL, TPJ, MPFC, and IPL (see Research Significance).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •No psychosis, no suicidal ideation or psychiatric hospitalization in past 3 months.
- •Usual MRI Exclusionary Criteria detailed in IRB
结局指标
主要结局
NIH-HEALS
时间窗: 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
时间窗: 12 weeks
fMRI Neuroimaging-will show change in activity in MPFC, SPL, TPJ, and IPL
次要结局
- Transcendence(12 weeks)
- Depression, Anxiety, Stress(12 weeks)
- Well-Being(12 weeks)
- Personally Independent Effects(12 weeks)
- PTSD(12 weeks)
研究者
John Calvin Chatlos, MD
Medical Director SATS
Rutgers, The State University of New Jersey