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AddictionNCT05485181

Validating Promoted Spiritual Experience

A study testing Spiritual Intervention in people with Addiction and Psychiatric Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Addiction, Psychiatric Disorder
What is being tested?
Spiritual Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
20 Jan 2023to 1 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • No psychosis, no suicidal ideation or psychiatric hospitalization in past 3 months.
  • Usual MRI Exclusionary Criteria detailed in IRB

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rutgers - The State University of New Jersey

    Piscataway, New Jersey, 08854

Other trials in United States

About this study

Official title: Validating Promoted Spiritual Experience: A Pilot Study

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.

  1. Objectives
  2. Pilot a psychological intervention that impacts a "spiritual" level.
  3. Measure efficacy improving well-being beyond explanation by usual personality factors.
  4. Identify biological changes with neuroimaging.
  5. 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.
Read more

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).
Read the 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.

Being tested
Spiritual Intervention
Keywords
spirituality, neuroimaging, CBT, self-worth, dignity
Medical subject headings
Behavior, Addictive, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spiritual InterventionBehavioural

    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.

Study groups in NCT05485181
Study groupRoleWhat they receive
Cohort 1Experimental8 subjects get psychological assessments and fMRI brain scan followed by 9 week psychotherapeutic intervention. With intervention completion, psychological assessments and fMRI scan are repeated.
Receives: Behavioral: Spiritual Intervention
Cohort 2Active comparator8 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.
Receives: Behavioral: Spiritual Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

  2. fMRI Scan

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

    Measured: 12 weeks

Secondary outcomes (5)

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2022
  2. Study start20 Jan 2023
  3. Primary completion1 Jul 2023
  4. Study completion1 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
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)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05485181
Sponsor's protocol ID
Pro2022000889
Status last verified
Apr 2024
First submitted
1 Aug 2022
Last updated
17 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual data that underlie the results of the study after de-identification.

Publications

  • 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.

    PubMed 29846531

Questions about this trial

What is this clinical trial studying?

A study testing Spiritual Intervention in people with Addiction and Psychiatric Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NIH-HEALS (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05485181, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.

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