Addiction, Psychiatric Disorder
Conditions
Keywords
spirituality, neuroimaging, CBT, self-worth, dignity
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.
Interventions
BEHAVIORALSpiritual 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.
Sponsors
Damon House
Rutgers Brain Health Institute
Rutgers, The State University of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Human Spirituality Scale | 12 weeks | 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. |
| NMI | 12 weeks | 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. |
| Spirituality - Mysticism Measure | 12 weeks | 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. |
| Theory Validity Self-Worth | 12 weeks | 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. |
Countries
United States
Outcome results
None listed