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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT04086654 Completed - Clinical trials for Post Traumatic Stress Disorder (PTSD)

Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD

Start date: March 2, 2020
Phase: N/A
Study type: Interventional

The aim of the project is to evaluate the psychometric properties (e.g. validity, reliability) of the International Trauma Interview (ITI) - German version. The ITI is a structured clinical interview that corresponds to the ICD-11 criteria for diagnosing both posttraumatic stress disorder (PTSD) and complex posttraumatic stress disorder (CPTSD). Eligible participants from psychiatric inpatient and outpatient facilities in Switzerland who have provided informed will complete various self-report measures about trauma-related mental health complaints. In addition, the ITI will be conducted by a trained clinician. Lastly, information from the medical chart will be further used for scientific purpose. The overall assessment will take approximately 1-2 hours to complete.

NCT ID: NCT04080141 Completed - Clinical trials for Post Traumatic Stress Disorder

Therapeutic Termination of Pregnancy and Psychiatric Implications

TTOP_PSY
Start date: January 1, 2012
Phase:
Study type: Observational

25 parental couples, with a prenatal diagnosis of fetal abnormality, had psychiatric evaluation for eligibility before TToP and after one year from the procedure. Women and unborn's fathers were also subjected to different psychometric questionnaires (HAM-D, HAM-A, BDI-II, PCL-5, IPDS, CTQ, CD-RISC-10).

NCT ID: NCT04077476 Completed - Depression Clinical Trials

Feasibility of Online Yoga With Facebook After Stillbirth

Start date: July 10, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the feasibility and effectiveness on PTSD symptoms of the addition of a Facebook group to an online yoga intervention for women following a stillbirth.

NCT ID: NCT04077437 Completed - Clinical trials for Posttraumatic Stress Disorder

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)

Start date: September 2, 2020
Phase: Phase 3
Study type: Interventional

Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop after a traumatic life experience that severely reduces quality of life. This multi-site, double-blind, placebo-controlled, randomized Phase 3 study will assess the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy compared to psychotherapy with placebo in participants diagnosed with at least moderate PTSD. The study will be conducted in up to N ≈ 100 participants. Participants will be randomized to receive a flexible dose of 80 or 120 mg MDMA or placebo, followed by a supplemental half-dose of 40 or 60 mg MDMA or placebo, unless contraindicated, with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period will be preceded by three Preparatory Sessions with the participant and therapists. During the Treatment Period, each Experimental Session will be followed by three Integrative Sessions of non-drug psychotherapy.

NCT ID: NCT04076839 Completed - Clinical trials for Post-traumatic Stress Disorder

The Effectiveness of a Cognitive Training Program, Goal Management Training, on Reducing Cognitive Difficulties and Improving Every-day Functioning in Individuals With Affective Disorders

Start date: October 13, 2017
Phase: N/A
Study type: Interventional

This study investigates the utility of Goal Management Training (GMT) in patients with post-traumatic stress disorder (PTSD), in order to determine if this treatment is effective in improving cognitive function in patients with frontal-temporally mediated brain dysfunction. Specifically, the primary aim of this study is to examine whether a standardized 9-week program of GMT results in durable improvements in cognitive functioning relative to a wait-list control group. A secondary aim will be to determine whether participation in the GMT group is associated with long-term functional improvements. It is hypothesized that at post-treatment, participants with PTSD assigned to the GMT groups will show greater improvement in neuropsychological test performance and greater functional improvement compared to those in the wait-list group; these gains are expected to be maintained at 3 month follow-up.

NCT ID: NCT04076215 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Biochemical and Physiological Response to Stressogenic Stimuli

Start date: September 2019
Phase: N/A
Study type: Interventional

Post-traumatic stress disorder (PTSD) is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. A psychiatric diagnosis of PTSD is currently based mainly on non-quantitative elements, such as interviews and subjective impressions. Discernable patterns of stress-related measures may constitute a physiological and biochemical phenotype characteristic of PTSD, which may serve as a biomarker and support diagnostic decisions, as well as personalized treatment plans. The current study is aimed at examining the possibility of basing a psychiatric diagnosis by measuring changes in the biochemical phenotype of participants with PTSD. Physiological and biochemical data will be collected from participants with and without PTSD using wearable sensors and adhesive biosensor patches. The data will be collected in two conditions: in a neutral, quiet situation, and during and following exposure to controlled stressogenic stimuli.

NCT ID: NCT04073862 Completed - Depressive Symptoms Clinical Trials

The Norwegian Stepped-Care TF-CBT Study

Start date: May 13, 2019
Phase: N/A
Study type: Interventional

Every day, a significant number of children and young people in Norway experience violence, abuse, or other potentially traumatizing events. These children are at risk of developing serious health problems such as post-traumatic stress disorder (PTSD), anxiety, depression, behavioral problems, and drug dependency. Moreover, when left unaddressed, trauma experiences in childhood can have long-term implications for work- and educational participation as well as later subjection to violence. Provision of accessible and situationally adaptable treatments can therefore have great benefits for children, families, and communities at large. In this project, the investigators will introduce the method of Stepped-Care Trauma-Focused Behavioral Cognitive Therapy (SC-TF-CBT) in a selection of 15 municipalities across Norway. SC-TF-CBT is a parent-led - therapist-assisted low-threshold method aimed at treating children exposed to abuse, sexual assault, or other trauma and who are at risk of developing more severe trauma-related difficulties (Salloum, et al. 2014). This is the first test of the method outside the US. The project's main aim is therefore to evaluate the feasibility and efficiency of the treatment in a Norwegian context through a pre-post design. The following questions are to be explored: 1. How does the SC-TF-CBT model fit the Norwegian health care culture and service system? 2. When testing Stepped-Care in a Norwegian context, the model is set to involve both the municipal and specialist service levels. Severe cases will be stepped up/transferred to the specialist level for TF-CBT treatment. How do these transitions work for the participating families, and what are the experiences and perspectives of practitioners and service-leaders regarding coordination and collaboration between service levels? 3. Do the children, parents, and therapists like working with the method? 4. Do recipients of the treatment (children and parents) report symptom improvement? 5. Which children and parents seem to benefit the most from the method, and who do not?

NCT ID: NCT04071600 Not yet recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Intranasal Neuropeptide Y in Clinical Trial in Level Two Trauma Patients for PTSD and Acute Stress Disorder

Start date: November 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Level 2 trauma patients admitted to Westchester Medical Center who consent and meet the inclusion criteria will answer a questionnaire, be tested on Beck Anxiety Index, assessed for vital signs and provide blood and urine samples for biomarker testing. before the intervention. Part 1 Dose Escalation: Subjects will receive a single infusion NPY or vehicle delivered to the upper nasal cavity with an intranasal device. The administration of intranasal NPY will follow the 3 plus 3 model and Fibonacci dose escalation scheme. Subjects will be assessed for Acute Stress Disorder (ASD) on the National Stressful Events Survey Acute Stress Disorder Sheet (NSESSS) at 3-7 and at 14-30 days post trauma, At >60 days post trauma to be evaluated with the PTSD Symptom Scale Interview for DSM-5 (PSS-I-5) and given the Beck Anxiety Inventory test. Part 2 Dose Expansion Cohort: Once the maximal tolerated dose (MTD) is determined, we will follow it by a dose expansion cohort to obtain preliminary evidence of efficacy of intranasal NPY to alter the severity of ASD and inhibit the progression to PTSD and the usefulness of several biomarkers.

NCT ID: NCT04071132 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD

Start date: August 2019
Phase:
Study type: Observational

A psychiatric diagnosis of post-traumatic stress disorder (PTSD) is currently based mainly on non-quantitative elements, such as interviews and subjective impressions. PTSD has physiological manifestations, some of which are likely reflected in the levels and ratios of certain stress-related proteins in the interstitial fluid and plasma. Discernable patterns of such stress-related proteins may constitute a biochemical phenotype characteristic of PTSD, which may serve as a biomarker and support diagnostic decisions, as well as personalized treatment plans. The current study is a non-interventional observational study aimed at examining the possibility of basing a psychiatric diagnosis by measuring changes in the biochemical phenotype of participants with PTSD.

NCT ID: NCT04070183 Recruiting - Depression Clinical Trials

POST Facilitation for Community Dwelling Older Adults (POST-RCT)

POST-RCT
Start date: May 11, 2020
Phase: N/A
Study type: Interventional

We propose to study the effects of Physician Orders for Scope of Treatment (POST) Facilitation in a randomized controlled trial in a population of community dwelling older adults who qualify for POLST facilitation, including those with normal cognition and those with Alzheimer's Disease and Related Disorders.