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Validating Promoted Spiritual Experience

Primary Purpose

Addiction, Psychiatric Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spiritual Intervention
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction focused on measuring spirituality, neuroimaging, CBT, self-worth, dignity

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rutgers - The State University of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cohort 1

Cohort 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
fMRI Scan
fMRI Neuroimaging-will show change in activity in MPFC, SPL, TPJ, and IPL

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
August 1, 2022
Last Updated
August 27, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Damon House, Rutgers Brain Health Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05485181
Brief Title
Validating Promoted Spiritual Experience
Official Title
Validating Promoted Spiritual Experience: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Damon House, Rutgers Brain Health Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Psychiatric Disorder
Keywords
spirituality, neuroimaging, CBT, self-worth, dignity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Spiritual Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
NIH-HEALS
Description
(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.
Time Frame
12 weeks
Title
fMRI Scan
Description
fMRI Neuroimaging-will show change in activity in MPFC, SPL, TPJ, and IPL
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Depression, Anxiety, Stress
Description
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.
Time Frame
12 weeks
Title
Well-Being
Description
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.
Time Frame
12 weeks
Title
Transcendence
Description
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.
Time Frame
12 weeks
Title
Personally Independent Effects
Description
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.
Time Frame
12 weeks
Title
PTSD
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Spirituality - Mysticism Measure
Description
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.
Time Frame
12 weeks
Title
Theory Validity Self-Worth
Description
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.
Time Frame
12 weeks
Title
NMI
Description
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.
Time Frame
12 weeks
Title
Human Spirituality Scale
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kasia Bieszczad, PhD
Organizational Affiliation
Rutgers University - Dept Psychology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nina Cooperman, PhD
Organizational Affiliation
Rutgers University - Dept Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers - The State University of New Jersey
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual data that underlie the results of the study after de-identification.
IPD Sharing Time Frame
3 months after published paper to 2 years.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal.
Citations:
PubMed Identifier
29846531
Citation
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.
Results Reference
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Validating Promoted Spiritual Experience

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