Symptoms and General Pathology

All Conditions

Wounds and Injuries

Behaviors and Mental Disorders

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Nervous System Diseases

Rare Diseases

Syndrome

Chronic Disease

Depression

Depressive Disorder

Acquired Immunodeficiency Syndrome

HIV Infections

Trauma, Nervous System

Chronic Graft Versus Host Disease

Anti-Infective Agents

All Drugs and Chemicals

Psychotropic Drugs

Metronidazole

Psilocybin

Hallucinogens

The participant will partner with psychiatrist to reduce SSRI's and on-board psilocybin, every M/W/F with a tailored dose of plant medicine psilocybin in the enhanced micro dose levels or 0.15g. to 0.33g with a monthly dose of 1 gram to 1.5 grams. Study Status, Oversight, Study Design, Outcome Measures, Eligibility, and informed consent will all be metrics of this study.

0.15g. thru 0.33g. tailored to participant, then Monthly a 1 time dose of 1gram to 1.5 grams dose of non-synthesized plant medicine psilocybin.

Psychiatrist QC scaling back SSRI's replacing with psilocybin.

The On-Boarding Provider will control dosage of the plant medicine via Telehealth.

0.15g. thru 0.33g., M/W/F and monthly 1 time a dose of 1g. to 1.5g monthly. 8 week trial.

Trauma

Ross M Allison, Plant Medicine On Boarding

Ross M Allison, Provider NPI 1437519899

Ross M Allison, Provider

The on-boarding of unregulatable trauma in the United States has reached 20%, which is 1/5 of the population. A population of this magnitude, by definition has now reached an epidemic classification. The population with chronic illness as stated: PTSD, Chronic Depression, MS, HIV, and SARS-CoV-2- Long Haulers Syndrome. These chronic conditions/illnesses many lead to death and are often the cause or perpetuate unregulated trauma and create an unstable population. Psychiatrists have testified before congress that the SSSRI medications are not fully functional cures and are not working for patients. Enchanced Psilocybin micro-dosing at the levels of 0.15g. ranging to 0.33g. every other day an 0.50g. for monthly maintenance of neural pathway production is proving to shave back the highjacked nervous system, thus stopping or rerouting the ruminating neurotransmitters, by rerouting thru new neural pathways. The body has a additional natural pathway in place then to decrease/stop these thoughts by have open pathways to process the thought differently. Serotonin is a neurotransmitter and which is the most famous of all the neurotransmitters. Serotonin is very similar in its compound structure to the plant medicine family of psilocybin, serotonin and psilocybin work very similarly with the 5h2A receptor in the human cortex ( the outer cortex of the brain ). Enhanced Microdosing of psilocybin at the levels of 0.15 to 0.33 and of 1 gram to 1.5 grams monthly for maintenance of the newly opened neural pathways is postulated to be a mental health game changer. Psilocybin helps shave back the highjacked nervous system which is a condition known as the diagnosis (SSD) Somatic Symptom Disorder. This research is believed accurate by proof on previous studies to process the subconscious held in the subconscious and shave back the somatic feelings resulting from the trauma of the individuals who have on-boarded chronic disease(s) of Trauma,PTSD, Unregulated Chronic Depression, MS, Cancer, HIV, and SARS-CoV-2- Long Haulers Syndrome.

Patients will work with a team: The Administrator Of Study, participants will be onboarded into the study by a Psychiatrist, Therapist LCPC, Micro Dosing Advisor/On-Boarding Provider, going forward referred to as a PMOP ( PLANT MEDICINE ON-BOARDING PROVIDER. The PMOP will administrate, chart dosing and file reports with the Psychiatrist, General Provider, Psychologist, or the LCPC Therapist. Adding a PMOP to Western Medicine could be the key to making treatment available at a functional cost.

The dosage will be ( enhanced micro-dosing which is 1 gram to 1.5 grams of psilocybin every other day for 5 days then moving into a M/W/F dose ranging in the enhanced micro-dose levels of 0.15G. thru 0..33 for 8 weeks.

Patients will be accepted in the study they must present with one of the following diagnosed conditions, chronic illness' of Trauma, PTSD, Unregulated Chronic Depression, MS, HIV, Cancer, or SARS-CoV-2- Long Haulers Syndrome. As participants with unregulated trauma can tend to have a severely compromised un-functional compromised immune system. This compromised low functioning compromised immune system creates additional health crisis and can cost a great deal of money for the patients and the healthcare system. As testified to congress, the SSRI's are not fully able to manage the on boarding of severe trauma resulting often in PTST/Trauma, these pharmaceuticals tend to become in effective for treatment within 6 months to a year. The SSRI's and pharmaceuticals available for treatment currently have a success rate of 35 %. These diagnosis' of mental compromise are currently being managed at great human cost and financial cost for a decade or more for many patients. Working in conjunction with the General Provider, Psychiatrist, Psychologist, and LCPC Therapist, with a PMOP ( Enhanced Micro Dosing Provider),The PMOP On-Boarding Provider will tailor the dose of plant medicine which this study postulates will result in a positive treatment and will result in improved (Quality of Life) and in the cases of terminal illness, result in (Dying Well)" A mind without rumination. As Stated, this study is looking for evidence this Plant Medicine Psilocybin would become a path to shave back the SSRI's and treat with dosing of of M/W/F of enhance Microdosing at the levels of 0.15g. thru 0.33G. The Monthly dose of 1 to 1.5 grams of Plant Medicine for maintenance of the increase in newly opened neural pathways. This Study will introduce Non Synthetic Psilocybin every other day for 8 weeks, and the 1G to 1.1.5 G once time per month.

The on-boarding of unregulatable trauma in the United States has reached 20%, which is 1/5 of the population. A population of this magnitude, by definition has reached an epidemic classification. The population with chronic illness as stated: Trauma, PTSD, Chronic Depression, MS, Caner, HIV, and SARS-CoV-2- Long Haulers Syndrome, these conditions are severe and the treatments are often not effective. These chronic illnesses which can result in unregulated trauma and create an unstable portion of the population. Psychiatrists have testified before congress that the SSRI's medications are not functional cures and are often not working for patients. Psilocybin micro-dosing by many studies is proving to shave back the highjacked nervous system, stopping or rerouting the neural pathways lessening or stopping the ruminating neurotransmitters. This is the 1st study to support the treatment in the Enhanced Microdosing levels in the range of 0.15g. to 0.33g, and adding a dose of 1g. to 1.5 g. monthly for maintence. The body has a natural path to stop these thoughts by a neurotransmitter called serotonin This famous neurotransmitter Serotonin, is very similar to the plant medicine family of psilocybin, Serotonin and Psilocybin work very similarly with the 5h2A receptor in the human cortex ( the outer cortex of the brain ). Enhanced Microdosing of 0.15 to 0.33 with month dose of 1 gram to 1.5 grams of psilocybin is postulated to shave back and reroute the highjacked nervous system known as the diagnosis (SSD) Somatic Symptom Disorder. This research is believed accurate by proof on previous studies to reverse back the somatic feelings resulting from the trauma of the individuals who are on boarding chronic diseases of PTSD, Chronic Depression, MS, HIV, Cancer, and SARS-CoV-2- Long Haulers Syndrome.

Ross Allison Administrator NPI#1437519899

Phase 1, 8 week time frame, M/W/F 0.15 to 0.33G, tailored dose of non synthesized psilocybin. A Monthly dose of 1 gram to 1.5 grams psilocybin. QC, controllers, Psychiatrist, LCPC Therapist, Plant Medicine On Boarding Specialist.

Northwest Therapies Trauma Psilocybin Study Compassionate Use Study

NW Trauma Therapies, Chronic Illness of Chronic Depression, PTSD, MS, HIV, and SARS-CoV-2, Long Haulers Syndrome. Treatment of Unregulaaible Trauma by the Treatment of Enhanced Micro Dosing the Levels of 0.15, Thru 0.33, With a Maintenance Dose of 1 Gram Per Month for Neural Pathway Increase of Non Synthesized Psilocybin, Using the Actual Plant to Regulate the Highjacked Nervous System.

GAF scoring system, Psychiatrist, LCPC Therapist, Administrator, On Boarding Plant Medicine Specialist, and Participant. will individually submit assessments monthly. A metrics of all 4 reports will be the result. QC measure to ensure the research participant is safe.

BAM, Brief Addiction Monitor, As psilocybin in all studies has shown not to be addictive. This study has in place a monthly BAM score by thePsychiatrist, LCPC Therapist, Administrator, On Boarding Plant Medicine Specialist. This BAM score will be done Monthly by all 4 listed persons. The metric of the combined scores will be the result. This QC measure is to protect the participant.

PLC-5 score resulting in 1. Monitoring symptom change during and after the treatment. 2. Screeing for PTSD. 3. Making a provisional PTSD Diagnosis. All 4 providers will complete this score monthly. The metric of the 4 providers will result the score.

World Health Organization

NWTraumatherapies

Neoplasms

Skin and Connective Tissue Diseases

Trauma and Stressor Related Disorders

Stress Disorders, Post-Traumatic

Ganglion Cysts

Stress Disorders, Traumatic

Synovial Cyst

Cysts

Psychological Trauma

Mental Disorders

Psychotic Disorders

Mucinoses

Connective Tissue Diseases

Central Nervous System Depressants

Anesthetics

Ropivacaine

Anesthetics, Local

Participants will receive 12 sessions of cognitive processing therapy (CPT) for PTSD combined with SGB during the first week of CPT.

Participant will receive 12 sessions of cognitive processing therapy (CPT) for PTSD and will receive SGB three months after completing the CPT sessions.

Cognitive processing therapy (CPT) is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters. CPT is generally delivered over 12 sessions and helps patients learn how to challenge and modify unhelpful beliefs related to the trauma. In so doing, the patient creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life. This treatment is strongly recommended for the treatment of PTSD.

Cognitive Processing Therapy (CPT)

SGB is a procedure that has demonstrated efficacy for the reduction of PTSD symptoms. SGB is performed using real-time ultrasonography with an in-plane technique, and consists of 7-10 mL of ropivacaine 0.5%, which is injected around and into the site of the ganglion at the level of the C4 and C6 anterior tubercle (Mulvaney, Curtis et al., 2020). Ropivacaine is a long-acting amide local anesthetic agent and a pure S-enantiomer with a high pKa and relatively low solubility. Patients are not sedated during the procedure. Successful sympathetic blockade is confirmed by the presence of Horner's syndrome, which is characterized by constriction of the pupil (miosis) and drooping of the upper eyelid (ptosis). If Horner's syndrome is not observed within 20 minutes of the first injection, the right-sided SGB is repeated one hour later using the same technique. If Horner's syndrome is not confirmed after the second injection, no additional injections are provided.

Stellate Ganglion Block

Craig J Bryan, PsyD

Our long-term goal is to improve clinical outcomes among patients receiving psychological treatment for posttraumatic stress disorder (PTSD). The primary objective of this project is to examine if stellate ganglion block (SGB) improves outcomes among military personnel and veterans receiving cognitive processing therapy (CPT), an empirically-supported psychological treatment for PTSD. To accomplish this objective, we will enroll adult military personnel and veterans with a current diagnosis of PTSD and/or subthreshold PTSD, provide CPT sessions over two weeks, administer SGB during or after CPT, and repeatedly assess key outcomes during follow-up.

Posttraumatic stress disorder (PTSD) is the most frequently diagnosed mental health condition among veterans (Tanielian \& Jaycox, 2008), with estimated rates of the condition ranging from 5-20% (Hoge, Castro, et al., 2004; Hoge, Terhakopian, et al., 2007; Milliken, Auchterlonie, \& Hoge, 2007; Tanielian \& Jaycox, 2008). PTSD is not just a consequence of combat, however; many military personnel and veterans experience noncombat-related traumas such as sexual assault and domestic abuse, or have histories of early life trauma such as child abuse that can also contribute to PTSD. Regardless of the associated event, PTSD is associated with a host of functional problems and negative outcomes among military personnel including occupational and marital dissatisfaction, violence, alcohol and substance abuse, and suicide (Hoge et al., 2004; Jakupcak et al., 2007; Panagioti, Gooding, \& Tarrier, 2009).

Cognitive behavioral treatments are the most highly efficacious treatments for PTSD. Cognitive Processing Therapy (CPT) is one such treatment that has garnered a significant amount of empirical support, with a recent metaanalysis showing it was the most effective treatment for PTSD (Watts et al., 2013), typically yielding a 50% or larger reduction in PTSD symptoms from pre- to posttreatment. Despite CPT's effectiveness, a significant percentage of military veterans continue to experience moderate to severe symptoms afterwards, and nearly half continue to meet full criteria for the diagnosis (Harik, Grubbs, \& Schnurr, 2016). Novel strategies for improving treatment outcomes are therefore needed.

Accumulating evidence supports the effectiveness of stellate ganglion block (SGB) for the treatment of PTSD. SGB is a procedure in which an injection of a long-acting local anesthetic, using ultrasound or fluoroscopic guidance, is made in the right side of the neck around the cervical sympathetic chain that controls the "fight or flight" response (the sympathetic nervous system). The cervical sympathetic chain is a two-way conduit that connects the parts of the brain that control the fight or flight response to the rest of the body. By blocking or "turning off" the cervical sympathetic chain, it is believed that the parts of the brain that control the fight or flight response are allowed to completely reset, resulting in long-term relief of the associated anxiety symptoms. Originally developed for the treatment of pain conditions, multiple case series have shown that right-sided SGB is associated with significant reductions in PTSD symptoms after SGB (Alino et al., 2013; Hickey et al., 2012; Lipov et al., 2008; Mulvaney et al., 2010, 2014), especially negative mood and hyperarousal symptoms (Lynch et al., 2016). Results of a recent randomized controlled trial in which SGB was compared to sham treatment further support the procedure's efficacy (Olmsted et al., 2019). In that study, PTSD symptom reduction in the SGB group was twice as large as the sham group. Research also supports SGB's safety and acceptability among patients with combat-related PTSD (McLean, 2015).

To date, however, the effectiveness of SGB when delivered in combination with first-line PTSD treatments like CPT has not been examined. The present study is designed to examine this issue from two perspectives. First, we will examine if the administration of SGB during CPT leads to larger reductions in PTSD symptoms as compared to CPT alone. Second, we will examine if the administration of SGB after CPT leads to significant reductions in PTSD symptoms among veterans who continue to experience moderate to severe symptoms after completing the therapy. To achieve this the study entails a single-blind, randomized clinical trial with wait list control. All participants will receive cognitive processing therapy (CPT), an empirically-supported psychological (non-medication) treatment for PTSD. Participants will be randomly assigned to receive stellate ganglion block (SGB) treatment at one of two time points: (1) during CPT or (2) three months after completing CPT. Outcomes will be assessed repeatedly for six months postbaseline.

All participants receive cognitive processing therapy during weeks 1 and 2. Participants will be randomly allocated to receive SGB during or 3 months after CPT.

Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD

Researchers interested in using IPD and/or computer code collected or generated as part of this study may do so by contacting the study PI. Researchers will be asked to complete a Data Use Request Form, which includes contact information, description of the research project for which the data and/or code would be used, specification of which data and/or code would be needed for their proposed project, an approximate time line for their proposed project, and authorship on their proposed project.

PTSD symptom severity will be assessed using PTSD PCL-5. The scale includes 20 items that rate the severity of each symptom using a 5-point scale, with items summed to provide an overall metric of PTSD symptom severity.

Severity will be measured using the Patient Health Questionnaire-9 (PHQ-9). The scale includes 9 items that rate the severity of each symptom using a 4-point scale, with items summed to provide an overall metric of depression symptom severity.

Severity will be measured using the Generalized Anxiety Disorder-7 (GAD-7) scale. The scale includes 7 items that rate the severity of each symptom using a 4-point scale, with items summed to provide an overall metric of anxiety symptom severity.

Symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15). The PHQ-15 is designed to assess the severity of 15 somatic/physical symptoms using a 3-point scale. Items can be summed to provide an overall metric of somatic symptoms and side effects.

Good end-state functioning is defined as having very low symptoms of both PTSD and depression, and is operationalized as a PCL-5 total score \< 20 and a PHQ-9 total score \< 10. It will be measured using a combination of these scores.

The Stellate Institute

Navy SEAL Foundation

Ohio State University

Stress, Trauma, and Resilience (STAR) Professor

Quality of Life

Conversations with the nurse and supportive phone calls. Conversation are structured and placed 1 and 3 months after surgery. Phone calls are carried out at two and three months after surgery.

Rehabilitation goals of patients with gynaecological cancer.

Kamila A. Holt, Ph.D. student

The purpose of this study is to provide new knowledge about:

* Integration of rehabilitation in a highly specialized gynaecological department.
* Development and testing of an individually adapted rehabilitation process.
* Needs for rehabilitation among women with gynaecological cancer.
* Connection between adult attachment style for women with gynaecological cancer and their quality of life, rehabilitation needs and symptoms of depression /PTSD.

The Need for Rehabilitation and the Connection With Attachment Styles Among Patients With Gynaecological Cancer

Rehabilitation and the Association With Attachment Styles Among Patients With Gynaecological Cancer

EORCT QLQ-C 30 (QLQ is quality of life questionnaire) and EORCT QLQ-OV28 (OV - Ovarian) and EORCT QLQ-EN ( EN - endometrial) 24 and EORCT QLQ- CX 24 ( CX - cervix.

Revised Adult Attachment Scale (RAAS- 18) is used to measure attachment style among women with gynaecological cancer.

MDI-12 (Major Depression Inventory), ICD-10 (International Classification of Diseases), measure the depression level in the period from baseline and 5 months after surgery.

To measure the Posttraumatic stress disorder we uge HTQ-17 (Harvard Trauma Questionnaire) for PTSD (Post Traumatic Stress Disorder).

University of Southern Denmark

Odense University Hospital

Kamila Adellund Holt

Principal Investigator

Chronic Pain

Pain

Neurologic Manifestations

Disease Attributes

Michelle Speaks, MBA

Sunil K Aggarwal, MD, PhD

Therry Eparwa, DNP

Leanna J Standish, ND, PhD

Therry Eparwa, DNP, FNP-BC

Leanna J Standish, ND, PhD, LAc

This epidemiologic research is being conducted as an observational prospective case series outcomes study of the use of advanced integrative specialty medical care and its effect on adult and pediatric patients with chronic or serious illnesses or mental health disorders.

There is growing interest in providing integrative medical care in conjunction with specialty medical care to expand the reach of integrative care to more chronically and seriously ill patient populations. At the AIMS Institute, the core specialties are naturopathy, palliative care, psychiatry, physiatry, and naturopathic oncology practiced via coordinated, team-based care by allopathic medical and psychiatric specialists, psychotherapists, specialized naturopathic physicians, advanced practice nurses, and targeted health educators, with the majority of care covered by insurance. Additionally incorporated are novel 'advanced' approaches, such as drug-assisted psychotherapy, medical cannabis education, sympathetic blocks, and some intravenous therapies.

This is an uncontrolled, prospective case series outcomes study of health-related quality of life outcomes in patients who receive care at AIMS Institute. A clinic-wide chart audit of patient characteristics and outcomes will be conducted prior to the start of enrollment.

AIMS Medical Outcomes Study

Measure quality of life using GAD-7, PHQ-9, and short form questionnaire.

Describe treatments prescribed and provided by AIMS Institute physicians abstracted from chart review.

Advanced Integrative Medical Science Institute

Respiratory Tract (Lung and Bronchial) Diseases

Inflammation

Prostatic Neoplasms

Sarcoma

Carcinoma, Renal Cell

Respiratory Aspiration

Urinary Bladder Neoplasms

Disease Progression

Kidney Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Kidney Diseases

Renal Cell Carcinoma

Soft Tissue Sarcoma

In the experimental group, participants will perform vagal breathing (VB), followed by the MSI, followed again by VB. The VB component will guide participants how to perform deep slow vagal breathing by inhaling and counting 1-5, holding their breath and counting 1-2, and exhaling and counting 1-5, during 2-5 minutes. The MSI component will teach participants to chronologically organize the segments of their memory of the incurable diagnosis, to verbally label feelings or somatic sensations they had at that moment, and to provide causal links between the event's segments and causality to their feelings and sensations, following the protocol of Gidron et al. (2001).

Participants in the control group will receive support and attention (usual care) and will be invited to recall announcement of the incurable disease progression. More precisely, they will be invited to express their associated thoughts and feelings, being free to talk about their experience, and the psychologist will react with empathy and support.

The MSI component will teach participants to chronologically organize the segments of their memory of the incurable diagnosis, to verbally label feelings or somatic sensations they had at that moment, and to provide causal links between the event's segments and causality to their feelings and sensations, following the protocol of Gidron et al. (2001).

In the MSI part, the patient will talk, and the therapist will note the different event parts and their real timing. Each time the patient says a feeling or sensation, the therapist will ask to verbally elaborate and provide the cause of these feelings and sensations. Then, the therapist will retell the story in a chronological manner, with verbal titles and causes for feelings and sensations. Finally, the patient will be asked to retell the story in this structured manner, after being explained how to do so.

vagal breathing (i.e., deep, paced breathing) is a way to increase HRV, and thus parasympathetic activation

Memory structuring intervention + Vagal breathing

support and attention (usual care)

Georges-Michel REICH, MD

The diagnosis and treatment trajectory of cancer can constitute a traumatic event because these can be perceived as sudden, catastrophic and life threatening. One common mental disorder following traumatic events is post-traumatic stress disorder (PTSD), described as reexperiencing of the event (e.g., having intrusive thoughts), having avoidance of trauma memories, emotional numbing, and experiencing hyperarousal symptoms. To date, and to the best of the investigator's knowledge, few studies have focused on PTSD in advanced cancer, but the existing data show that these patients are at risk for experiencing PTSD symptoms.

Among the early interventions for preventing PTSD in people confronted by traumatic events is group debriefing, the retelling of the event, receiving empathy and compassion, and being encouraged to express feelings. However, four meta-analyses found debriefing to be ineffective. A neuroscience-based and evidence-based alternative may be the Memory Structuring Intervention (MSI) that tries to shift trauma processing from a limbic, emotional and somatic level to a frontal-cortical, cognitive and verbal level of processing. The MSI tries to achieve this shift by teaching people confronted with traumatic events to chronologically organize the segments of the event, to verbally label feelings or somatic sensations rather than re-experience them, and to provide causal links between the event's segments and causality to their feelings and sensations Since in males, sympathetic responses were more predictive of PTSD than in females , parasympathetic activation may be needed to be added to the MSI, for men. A main branch of the parasympathetic response is the vagus nerve, whose non-invasive index is Heart Rate Variability (HRV). One way to increase HRV, and thus parasympathetic activation, is through vagal breathing (i.e., deep, paced breathing). Therefore, adding to the MSI deep vagal breathing (VB) to reduce sympathetic hyperactivity, may increase connectivity between the amygdala and the frontal cortex. This may also increase the emotional regulation possibly yielded by the MSI, however in both genders.

The effects of the MSI + vagal breathing on PTSD symptoms and on prognosis in advanced cancer patients receiving announcement of terminal cancer have never been investigated. Furthermore, whether reduced inflammation and increased emotional regulation may account for such effects needs to be investigated at the fundamental level. This project reflects the merging of neuroscience, psychooncology and psychoneuroimmunology for better understanding and treating cancer patients, as well as their partners.

Procedure for patients and partners:

Patients will be informed about the study by their treating oncologist at the end of the appointment, when they will be informed about the metastatic incurable progression of their disease (announcement visit). Oncologists will provide the patients a written description of the study, presenting the information previously orally provided by them, together with the consent form, to fill in. Signed informed consent will be sent back by post-mail if necessary (if participants ask for a time to think), using a pre-stamped envelope. Due to the objective to prevent distress, recruitment to the study and random assignment of the intervention need to be performed within the 7 days following this announcement visit, after making sure the patient is eligible for the study according to the inclusion and exclusion criteria.

Early after the announcement visit and consent collection, the clinical psychologist will call the patient before randomization in order to assess patients' level of stress from 1 (no stress) to 10 (maximal stress). Patients with a level higher or equal than 4 will be randomized in the study. For the patients with a stress level below or equal than 3, only background information will be collected in the study. These patients will receive the standard care.

Patients and their spouse will be randomly assigned together (i.e., if the spouse participates, he/she will be allocated to the same treatment arm as the patient) to receive the MSI + VB (experimental group) or to receive the supportive listening and attention (usual care serving as control condition), using an online centralized randomization program. Randomization will be implemented after the receipt of the consent form and balanced by (1) cancer type (bladder, prostate, kidney, colorectal cancer, sarcoma), (2) gender, as these two variables are identified as risk factors of PTSD (for cancer type) and as impacting the MSI effects (for gender) in the literature, and (3) the presence of the spouse during the announcement visit (yes/no), using a dynamic allocation program (minimization with a random factor set at 0.8).

For reasons of feasibility, no pre-screening aiming at including patients with a high risk of distress and potentially with high risk for developing PTSD will be realized. However, during the first telephone session, the psychologist will assess patients' level of stress using a 10-point likert scale, similar to a past study, before and after the MSI + VB intervention or the support and attention control session. This scale includes asking patients on a scale from 1 (no stress) to 10 (maximal stress) their level The treatment consists of a single telephone session conducted by a trained therapist maximum 10 days after receiving the announcement of the incurable disease progression. This is done in order to prevent PTSD, as was already done when the MSI treatment was developed in traffic accident survivors (Gidron et al., 2001, 2007). The same trained therapist will provide the MSI + VB intervention to the experimental group and give support and attention to the control group, in order to control for therapist's effects. This telephone session will be followed by 3 follow-up telephone assessments (a week, a month and 3 months after the previous telephone session), for collecting data by a research assistant who will not know in which group the participants are. All the sessions and interviews of the patient and his/her spouse (for treatments and for follow-up measures) will be conducted separately, and the information will remain confidential between the patient and the spouse. Each of these telephone calls will be conducted from the participating center, in order contact details of the participants remain inside the medical center to ensure the confidentiality of the data.

Experimental intervention. In the experimental group, participants will perform vagal breathing (VB), followed by the MSI, followed again by VB. The VB component will guide participants how to perform deep slow vagal breathing by inhaling and counting 1-5, holding their breath and counting 1-2, and exhaling and counting 1-5, during 2-5 minutes. The MSI component will teach participants to chronologically organize the segments of their memory of the incurable diagnosis, to verbally label feelings or somatic sensations they had at that moment, and to provide causal links between the event's segments and causality to their feelings and sensations, following the protocol of Gidron et al. (2001). In the MSI part, the patient will talk, and the therapist will note the different event parts and their real timing. Each time the patient says a feeling or sensation, the therapist will ask to verbally elaborate and provide the cause of these feelings and sensations. Then, the therapist will retell the story in a chronological manner, with verbal titles and causes for feelings and sensations. Finally, the patient will be asked to retell the story in this structured manner, after being explained how to do so.

patients in the MSI + VB group will be encouraged to perform it daily, for 5-10min, and especially before going to bed, to reduce any sleeping arousal associated with PTSD symptoms

Control. Participants in the control group will receive support and attention (usual care) and will be invited to recall announcement of the incurable disease progression. More precisely, they will be invited to express their associated thoughts and feelings, being free to talk about their experience, and the psychologist will react with empathy and support.

At Baseline for both arms, i.e., at the beginning of the telephone interview where the trained therapist will call the participants, the therapist will collect background information including age, gender, years of education, self-reported length of couple relationship and psychotropic medication (anxiolytic, antidepressant) in order to control the association between PTSD symptoms and anxiety and/or depressive disorder.

1. PTSD symptoms will be assessed by the post-traumatic checklist for DSM 5 (PCL-5; Weathers et al., 2013, French translation and validation by Ashbaugh et al., 2016).
2. Emotional regulation will be assessed by the BACQ scale (Finset et al., 2002).
3. Quality of life will be assessed by the EuroQol-5D scale (EQ-5D 3L)

In both groups, the trained therapist will also evaluate the degree of "natural" structuring regarding the way in which the patients/partners talk about the announcement visit. More precisely, the trained therapist will rate both groups on their level of chronological organization of their story from 1 = totally disorganized; 2 = a bit organized; 3 = chronologically very organized (in the MSI + VB group: before and after the MSI training; in the control group: at the first time they recall their story)

Afterwards, three follows-ups will be conducted by telephone: 1 week, 1 month and 3 months after the first intervention or control phone session.A research assistant blind to group assignments will collect the same self-reported measures initially collected by telephone at the first phone meeting. In sum, levels of PTSD symptoms and quality of life will be assessed at each time (initial phone meeting, 1 week, 1 month and 3 months). However, emotional regulation will be assessed at the first phone meeting and at one month only, in order to reduce patients' burden.

Patients and partners will also be asked if they have talked about the event, to recall how and how often they have spoken about the event since the last phone call.

For all the groups, medical information including type and stage of cancer and type of cancer treatments will be collected at baseline by the medical staff (as summarized in the table below). Levels of albumin and levels of C-reactive protein (CRP, reflecting inflammation) will also be obtained at baseline, 1 month and 3 months when patients will come in any case to the hospital for their medical appointments (no medical appointment is anticipated at 1 week, hence the absence of CRP and albumin measures at this time). Survival time will be monitored for all patients as well until the final analysis. We will calculate the quality-adjusted life years (QALY) for all patients, to reflect both quantity and quality of survival. This will be done using the length of survival weighted by patients' score on the EQ-5D scale.

The research assistant blind to group assignments is responsible to conduct the three follows-ups

Effects of a Neuroscience-based Technique on Cancer Patients Announced of a Palliative Disease Progression and Partners

Effects of a Neuroscience-based Technique on Post-traumatic Stress Disorder Symptoms, Inflammation, and Survival in Cancer Patients Announced of a Palliative Disease Progression and Their Partners

PCL-5 means PTSD Checklist for DSM-5. This self-report rating scale assesses the presence and severity of PTSD symptoms. It includes 20 items. Each item is rated on a 0 (not at all) to 4 (extremely) response scale. The total score (0-80) is obtained by summing the scores for each of the 20 items. This total score reflects the severity of PTSD symptoms, and a cut-off of 32 reflects probable PTSD.

Comparison of the PCL-5 score (PTSD symptoms severity score obtained by summing the scores for each of the 20 items) at 1 week, 1 month and 3 months after the first intervention.

PCL-5 means PTSD Checklist for DSM-5. This self-report rating scale assesses the presence and severity of PTSD symptoms. It includes 20 items. Each item is rated on a 0 (not at all) to 4 (extremely) response scale. The total score (0-80) is obtained by summing the scores for each of the 20 items. This total score reflects the severity of PTSD symptoms, and a cut-off of 32 reflects probable PTSD.

EQ-5D essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his health state in each of the dimensions. This decision results into a 1-digit number (number 1, 2, or 3) that expresses having no problems for 1, having some problems for 2, and having extreme problems for 3. The digits for the five dimensions is combined into a 5-digit number that describes the patient's health state, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

QALY is the Quality-adjusted life years. This outcome will be calculating using the EQ-5D score and the survival time ,in order to take into account both the quantity and quality of life generated by an intervention. One QALY equates to one year in perfect health. If an individual's health is below this maximum, QALYs are accrued at a rate of less than 1 per year. To be dead is associated with 0 QALYs.

Inflammation level will be assessed using CRP and albumin level

Emotion regulation evaluated by the BACQ scale. BACQ scale is the Brief Approach/Avoidance Coping Questionnaire.The scale contains 12 items based on a 5-point Likert scale ranging from 1 " Strongly disagree " to 5 "Totally agree ". The total score is calculated by the sum of the items (ranging from 12 to 60). It is also possible to calculate three subscores (i.e., approach index; resignation and withdrawal index; diversion index). The higher the total score, the more the participant use an approach coping.

Improvement of the PCL-5 score at 3 months compared to Baseline. PCL-5 means PTSD Checklist for DSM-5. This self-report rating scale assesses the presence and severity of PTSD symptoms. It includes 20 items. Each item is rated on a 0 (not at all) to 4 (extremely) response scale. The total score (0-80) is obtained by summing the scores for each of the 20 items. This total score reflects the severity of PTSD symptoms, and a cut-off of 32 reflects probable PTSD.

Evolution of PCL-5 score in the first 3 months, especially at 1 month. PCL-5 means PTSD Checklist for DSM-5. This self-report rating scale assesses the presence and severity of PTSD symptoms. It includes 20 items. Each item is rated on a 0 (not at all) to 4 (extremely) response scale. The total score (0-80) is obtained by summing the scores for each of the 20 items. This total score reflects the severity of PTSD symptoms, and a cut-off of 32 reflects probable PTSD.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Northwest Therapies Trauma Psilocybin Study Compassionate Use Study	NCT05042466	Trauma, Nervous...	Trauma	21 Years - 99 Years	NWTraumatherapies
Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD	NCT05107752	PTSD Trauma and Stre... Trauma, Psychol... Post Traumatic ...	Cognitive Proce... Stellate Gangli...	18 Years -	Ohio State University
The Need for Rehabilitation and the Connection With Attachment Styles Among Patients With Gynaecological Cancer	NCT01638741	Needs for Rehab... Adult Attachmen... Quality of Life... Depression PTSD	Rehabilitation ...	20 Years - 75 Years	Odense University Hospital
AIMS Medical Outcomes Study	NCT04512755	Mental Health I... PTSD Pain Chronic Pain Chronic Disease		-	Advanced Integrative Medical Science Institute
Effects of a Neuroscience-based Technique on Cancer Patients Announced of a Palliative Disease Progression and Partners	NCT03652298	Colorectal Canc... Bladder Cancer Prostate Cancer Kidney Cancer Advanced Sarcom...	Memory structur... support and att...	18 Years -	Centre Oscar Lambret
AIMS Medical Outcomes Study	NCT04512755	Mental Health I... PTSD Pain Chronic Pain Chronic Disease		-	Advanced Integrative Medical Science Institute
NYSCF Scientific Discovery Biobank	NCT06203106	ALS Amyotrophic Lat... Alzheimer Disea... Alzheimer Disea... Alzheimer Disea... Batten Disease Corticobasal De... Dementia Frontotemporal ... Huntington Dise... Lewy Body Disea... Multiple Sclero... Multiple System... Parkinson Disea... Parkinson's Dis... Progressive Sup... INAD Diabetes Diabetes Mellit... Diabetes Mellit... Diabetes Mellit... Macular Degener... Ovarian Cancer Cervical Cancer Uterine Cancer Vaginal Cancer Vulvar Cancer PTSD Post Traumatic ...	Biological Samp...	30 Days -	New York Stem Cell Foundation Research Institute
Effects of Stellate Ganglion Block and Superior Cervical Ganglion Block on Sleep and Recovery	NCT05470361	PTSD	stellate gangli...	18 Years - 95 Years	The University of Queensland
Effects of Stellate Ganglion Block and Superior Cervical Ganglion Block on Sleep and Recovery	NCT05470361	PTSD	stellate gangli...	18 Years - 95 Years	The University of Queensland

Spots Global Cancer Trial Database for ptsd

Every month we try and update this database with for ptsd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ptsd

Every month we try and update this database with for ptsd cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ptsd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.