NCT06235177

Brief Summary

Psychoneuromentalism Disorder is a disorder arising in the mind; that is related to the mental and emotional state of a person. It is the science of mental life. The body has a natural design to heal itself. This is a mental phenomena that cannot be explained, until now. Psychoneuromentalism Disorder is a new condition resulting from behavioral impairments, neurodiversity, and neurobehavioral dysfunctions that are related to the mental and emotional state of a participant.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2024

Shorter than P25 for early_phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2021

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2025

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

December 13, 2021

Last Update Submit

August 9, 2024

Conditions

Keywords

PsychologyNeuroscienceMental HealthDisorderStressAnxietyPsychoneuromentalism DisorderADHDFatigue

Outcome Measures

Primary Outcomes (1)

  • Primary Outcomes for those diagnosed with Psychoneuromentalism Disorder

    Memory will become more clear.

    4-6 weeks

Secondary Outcomes (1)

  • Primary Outcomes for those diagnosed with Psychoneuromentalism Disorder

    8-12 weeks

Other Outcomes (2)

  • Primary Outcomes for those diagnosed with Psychoneuromentalism Disorder

    2-3 weeks

  • Primary Outcomes for those diagnosed with Psychoneuromentalism Disorder

    6-8 weeks

Study Arms (1)

Intervention Techniques for Psychoneuromentalism Disorder

EXPERIMENTAL

The Interventions to be administered will be as follows: 1. Ashwagandha Herb Tincture and Supplement 2. Damiana Herb Tincture 3. Passion Flower Herb Tincture 4. Grapeseed Extract- Capsule 5. Rhodiola- Herb Tincture 6. Sea Moss Supplement Capsule 7. Theocentric Psychological Counseling 8. Clinical Yoga 9. Meditation 10. Mental Imagery 11. Decompartmentalization Framework 12. Dietary Supplements 13. Applied Relaxation (Music Meditation, Breathing Techniques) 14. Pain Relaxation Techniques 15. Meridian Acupuncture

Combination Product: Decompartmentalization FrameworkDietary Supplement: Liquid Herbal TIncturesOther: Mental ImageryDiagnostic Test: Clinical YogaDietary Supplement: Dietary SupplementsBehavioral: Applied RelaxationBehavioral: Pain Relaxation TechniquesBehavioral: Comprehensive Theocentric Psychological Assessment

Interventions

I will also be using mental imagery, consciousness, cognition, and cognitive psychology during this study to show the effectiveness of the conscious mind, and how the mind can influence behavior. Decompartmentalize means to remove excessive compartmentalization; to restore from a compartmentalized state; to merge back together.

Intervention Techniques for Psychoneuromentalism Disorder
Liquid Herbal TIncturesDIETARY_SUPPLEMENT

I will make and administer liquid herbal tinctures that will be made from all natural leafs, roots and flowers. I will focus on and track the participants' diagnosis, side effects, and how they feel before, during and after taking the liquid tincture.

Also known as: Herbal Tincture
Intervention Techniques for Psychoneuromentalism Disorder

I will have the participants focus on a particular shape, sound or image that they can see, think, or hear. This will allow the participant to have a clear mind, and release any negative thoughts, negative energy and boost their moods and their 5 senses.

Also known as: Mindfulness
Intervention Techniques for Psychoneuromentalism Disorder
Clinical YogaDIAGNOSTIC_TEST

I will show the participants many different yoga positions that will give them a peace of mind, stretch their muscles and release any tension throughout their body, and have an overall well-being, as well as promoting mindfulness.

Also known as: Yoga, Mediation
Intervention Techniques for Psychoneuromentalism Disorder
Dietary SupplementsDIETARY_SUPPLEMENT

I will have the participants take an herbal supplement and/or vitamin that relates to the symptoms and current issues/diagnosis they have. The Dietary Supplements/Vitamins will enhance their capacity to overcome their health conditions, protect their body from unwanted germs and bacteria, and relieve the participants' mind and body from the symptoms they are experiencing based on their current condition.

Also known as: Vitamins
Intervention Techniques for Psychoneuromentalism Disorder

Applied Relaxation is a specialized form of relaxation training that aims to teach the participant how to relax in common social situations. Mindfulness training encourages participants to gain psychological distance from their worries and negative emotions, seeing them as an observer would see them. 2 types of mindfulness will be used, which is mindfulness-based stress reduction and mindfulness-based cognitive therapy. Treatment starts with general education about stress and social anxiety.

Also known as: Meditation, Breathing Exercises, Music Therapy
Intervention Techniques for Psychoneuromentalism Disorder

Relaxation can reduce the feelings of stress, helping them to gain more control. Reduce pain by decreasing muscle tension, aches and pains. The body releases endorphins (the body's natural pain-killers) to relieve pain. Yoga incorporates breath control, meditation, and gentle movements to stretch and strengthen muscles. Mind-body techniques, which includes meditation, mindfulness, and breathing exercises help you restore a sense of control over your body and turn down the "fight or flight" response, which can worsen chronic muscle tension and pain.

Intervention Techniques for Psychoneuromentalism Disorder

To enhance the lives of add to the lives of those who are well adjusted but know they have a greater potential within themselves to ring forth and live more fulfilling lives,

Intervention Techniques for Psychoneuromentalism Disorder

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Diagnosis of anxiety, schizoaffective disorder, bipolar disorder, ADHD, Dementia, or other psychological issues and disorders; autoimmune disease such as fibromyalgia, lupus, and thyroid disease, neuropathy and chronic fatigue syndrome
  • Must be able to swallow tablets

You may not qualify if:

  • Children under the age of 18
  • Must not be on any blood thinner medications
  • Chronically ill patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychotic DisordersBipolar DisorderDissociative DisordersStress Disorders, TraumaticDementiaAnxiety DisordersFatigue Syndrome, ChronicPsychological Well-BeingDiseaseAttention Deficit Disorder with HyperactivityFatigue

Interventions

MindfulnessDietary SupplementsVitaminsMeditationBreathing ExercisesMusic Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersTrauma and Stressor Related DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMuscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPersonal SatisfactionBehaviorAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersSigns and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsMind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyExercise Movement TechniquesPhysical Therapy ModalitiesSensory Art TherapiesRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • Faith A Richardson, BSW, MPA, PhD

    Restored Purpose Counseling Alliance

    STUDY DIRECTOR

Central Study Contacts

Faith A Richardson, BSW, MPA, PhD

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Masking Details
Recent studies suggest that neurotrophic factors play an important role in the pathogenesis of depression as well as the therapies for depression.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: The purpose of this study is to find individuals who do not have a primary psychological disorder prior to a medical condition, behavior change, or a shift in the mind and body from a traumatic experience, PTSD, Dementia, Stress, and physical limitations that has caused a psychological issue.The other purpose is to assist the participants in naturopathy/holistic medicine treatments, which will allow them to not only recover from their current condition, but to also have an overall well-being, become more sustainable in their daily lives, and have an overall sense of health.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2021

First Posted

January 31, 2024

Study Start

October 10, 2024

Primary Completion

June 29, 2025

Study Completion

September 19, 2025

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

At this time, I don't have a specific plan set in place. I will take the necessary steps to make the IPD available to other researchers once I come up with a description.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
The data will become available on January 7, 2023.
Access Criteria
Please send me an email if you would like to have access to my research and reports.
More information