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Completed

NCT Number: NCT05485181

Validating Promoted Spiritual Experience

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).

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Key information

Conditions

Addiction Behavior Behavior, Addictive Compulsive Behavior Impulsive Behavior Mental Disorders Psychiatric Disorder

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers - The State University of New Jersey

Piscataway, New Jersey, 08854, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. NIH-HEALS

    Time frame: 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.

  2. fMRI Scan

    Time frame: 12 weeks

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

Secondary outcomes

  1. Depression, Anxiety, Stress

    Time frame: 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.

  2. Well-Being

    Time frame: 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.

  3. Transcendence

    Time frame: 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.

  4. Personally Independent Effects

    Time frame: 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.

  5. PTSD

    Time frame: 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 outcomes

  1. Spirituality - Mysticism Measure

    Time frame: 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.

  2. Theory Validity Self-Worth

    Time frame: 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.

  3. NMI

    Time frame: 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.

  4. Human Spirituality Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Damon House
  • Rutgers Brain Health Institute

Registry information

Official study title

Validating Promoted Spiritual Experience: A Pilot Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2022
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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