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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT06469333 Not yet recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Theories of Working Memory and Consolidation/RECOnsolidation in the Process of Resorption of Post-traumatic Symptoms.

Start date: June 2024
Phase: N/A
Study type: Interventional

EMDR is a psychotherapeutic approach recommended by the World Health Organization (WHO) for the treatment of disorders such as post-traumatic stress disorder, anxiety, depression and, more generally, psychological distress. In all these disorders, intrusions are one of the symptoms leading to intense emotional distress. EMDR therapy, by making intrusions less emotional and less present in the mind (i.e. less vivid), would reduce psychological distress. This symptomatological reduction would be made possible by the therapist's application of alternating bilateral visual (rapid eye movements following a point from left to right), auditory (tones emitted alternately in the right ear and then in the left ear) and/or tactile (tapping with fingers on the left and right shoulders alternately) stimulations administered while the patient concentrates on his or her intrusive thoughts. Accordingly, the aim of this research is to investigate the efficacy of self-administration of Alternating Bilateral Stimulations (ABS), on the emotional intensity (emotionality) associated with negative intrusive thoughts (or intrusions).

NCT ID: NCT06463431 Not yet recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Cognitive Processing Therapy to Treat PTSD and Sexually Transmitted Infections Among Men Who Have Sex With Men

CPT-T
Start date: August 27, 2024
Phase: N/A
Study type: Interventional

Gay, bisexual, queer, and other men who have sex with men (GBM) continue to bear a disproportionate burden of the sexually transmitted and blood-borne infections (STBBI), largely attributable to efficient transmission during condomless anal sex (CAS). In 2020, GBM accounted for 46.6% of new HIV diagnoses in Canada. Incidence of syphilis, chlamydia and gonorrhea have risen among men who have sex with men (MSM), especially among HIV+ GBM living in Canadian urban centres, including Toronto. Post-traumatic stress disorder prevalence is also higher among GBM than among heterosexual men. Post-traumatic stress disorder (PTSD) is a risk factor for CAS and related STBBI among GBM. Despite the strong association between PTSD and STBBI risk among GBM, no studies have examined the efficacy of PTSD treatment on STBBI risk among GBM. PTSD is highly treatable via cognitive-behavioural therapies, including by Cognitive Processing Therapy. The present study will provide preliminary feasibility and acceptability data for a novel and innovative STI/HIV prevention intervention for GBQM. This intervention builds upon empirically supported treatments for PTSD, including PTSD-related substance use, by adding risk reduction counselling to reduce sexually transmitted infections (STI) and HIV sexual risk behaviour. The present study will provide trial data for a novel and innovative STBBI prevention psychotherapy for GBM that could be administered by mental health providers across Canada. The intervention will consist of 15 1-hour sessions of an integrated cognitive-behavioural approach using Cognitive Processing Therapy (CPT) to treat PTSD and to reduce STBBI risks among GBQM. The primary outcome will be condomless anal sex with casual partners. The secondary outcomes will be PTSD prevalence, trauma symptoms, problematic substance use, and PTSD-related avoidance of negative thoughts and feelings. This psychotherapy intervention will build upon empirically supported interventions to reduce HIV risk

NCT ID: NCT06456190 Not yet recruiting - Opioid Use Clinical Trials

Testing STAR and TexSTAR: A Video and Text Messaging Intervention

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

This NIDA-funded HEAL Initiative: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence R61 seeks to develop and test a brief video intervention to deliver during Sexual Assault Nurse Examiner (SANE) care and a brief text messaging intervention to deliver in the month after the assault to prevent the onset or escalation of PTSD and opioid misuse among survivors of sexual assault.

NCT ID: NCT06449326 Not yet recruiting - Clinical trials for Posttraumatic Stress Disorder

Multimodal Image Analysis and Guidance of Neuromodulation for Trauma-Related Symptoms

MAGNETS
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

MAGNETS is a prospective, randomized, parallel-design, sham-controlled clinical trial of accelerated, functional magnetic resonance imaging (fMRI)-guided intermittent theta burst stimulation (iTBS) to the right dorsolateral prefrontal cortex (dlPFC) for chronic symptoms of posttraumatic stress disorder (PTSD) in a comorbid Veteran population.

NCT ID: NCT06434766 Not yet recruiting - Clinical trials for Posttraumatic Stress Disorder

Multicenter iTBS Neuromodulation for PTSD Treatment

TMCP
Start date: May 2024
Phase: N/A
Study type: Interventional

The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex (M1) as adjunct treatment for PTSD patients. The primary outcome measure includes changes in PTSD symptom severity, with secondary outcome measures focusing on negative moods improvements, quality of life and social/occupation functioning and functional connectivity of the brain.

NCT ID: NCT06432400 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Identification of Post-Traumatic Stress Disorder in Adult Patients With Substance Use Disorders

IRTIPAP
Start date: June 2024
Phase: N/A
Study type: Interventional

The aim of this study is to show that early identification of PTSD and CPTSD would increase recognition of these disorders and facilitate diagnosis, referral and recovery.

NCT ID: NCT06431022 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Web-administered STAIR for Patients on Behavioral Health Waitlists

webSTAIR
Start date: July 2024
Phase: N/A
Study type: Interventional

Posttraumatic stress disorder (PTSD) is a significant public health challenge with population prevalence rates in the US between 6.1 to 9.2%. There are large racial and socioeconomic inequities in access to PTSD treatment, as up to half (30-50%) of patients in safety net clinical settings meet criteria for PTSD, yet only 13% receive any behavioral health treatment. Workforce shortages are one major barrier to accessing care. Additional barriers to care can include heightened mental health stigma and mistrust of health services. Digital mental health interventions (DMHIs) may be suitable within the continuum of care for PTSD in hospital settings, given their potential for rapid-access, scalability, and the high acceptability of DMHI among individuals with high stigma and social needs. Among the available DMHIs for PTSD, the investigators have selected web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), based on emerging scientific evidence and a close collaboration with Boston Medinal Center (BMC) users (patients and providers) in a previous pilot study in primary care. The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education (RESTORE) Center's subspecialty clinic.

NCT ID: NCT06419959 Not yet recruiting - Clinical trials for Cardiovascular Diseases

NightWare and Cardiovascular Health in Veterans With PTSD

Start date: October 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.

NCT ID: NCT06418178 Not yet recruiting - Clinical trials for Posttraumatic Stress Disorder

Dose Optimization of MDMA-Assisted Therapy for PTSD

DosOp
Start date: October 2024
Phase: Phase 2
Study type: Interventional

This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

NCT ID: NCT06412757 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Silexan in the Treatment Of Posttraumatic Stress Disorder Trial

STOP
Start date: June 1, 2024
Phase: Phase 3
Study type: Interventional

Posttraumatic stress disorder (PTSD) is a common and debilitating mental illness. Current treatments for PTSD include psychotherapy and antidepressant medications. Many patients are unable to tolerate psychotherapy for PTSD and drop out of it. In addition, its effectiveness is limited. Up to 50 percent of patients who receive psychotherapy do not benefit from it. Antidepressant medications have only small benefits in PTSD. They also have unpleasant side effects that can make patients unwilling to take them. There is an urgent need to develop new treatments for PTSD that work and are well-tolerated. Silexan has the potential to provide an important alternative treatment for PTSD. Silexan is derived from lavender oil. It is taken orally in the form of capsules. It is currently available over-the-counter in 14 countries, including Australia and the United States. Previous research has shown that it is an effective treatment for anxiety disorders, including Generalized Anxiety Disorder. It is also well-tolerated by patients. The only side effects that have been identified so far are mild gastrointestinal symptoms (including burping and breath odour) and these are uncommon. The results of a small pilot study suggest that Silexan may also be effective and well-tolerated in PTSD. The STOP trial is a clinical trial that aims to investigate whether adding Silexan to treatment-as-usual improves PTSD symptoms in adults with PTSD. The trial will recruit 224 participants. Participants will be randomly assigned to take Silexan or a placebo (look-alike dummy pills) daily in addition to their usual medications for 12 weeks. The severity of their PTSD symptoms will be assessed prior to and at the end of this 12-week period. The STOP trial has the potential to obtain definitive evidence regarding whether Silexan helps treat symptoms of PTSD. If Silexan is found to be an effective treatment for PTSD, the pool of patients who could potentially benefit from this treatment includes any adults with PTSD. Silexan is already available over-the-counter at a relatively low cost so there will be few barriers to accessing this treatment.