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Showing 1-20 of 216 trials
NCT06386003
This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).
NCT07670702
This study is evaluating the long-term safety and efficacy of TSND-201 in adults with PTSD. Participants that have completed a double-blind clinical trial with TNSD-201 for PTSD will be invited to participate in this open-label extension trial. Each participant will be able to receive up to three Treatment Courses over the duration of the study (up to 48 weeks). Each Treatment Course includes 4 dosing sessions, spaced one week apart.
NCT07175025
The NEXT Study is a randomized controlled pilot examining the feasibility and acceptability of a revised perinatal PTSD protocol. This study will randomize perinatal participants with PTSD to receive NET (n=45); treatment group) and will be compared to perinatal women randomized to usual care (n=45; comparator group). The overall objective of this project is to determine the most feasible and acceptable protocol for a brief virtual perinatal PTSD intervention.
NCT05929911
People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.
NCT06635486
This project aims to improve mental health support for Venezuelan migrants living in Lima, Peru, who often face challenges like anxiety, depression, and post-traumatic stress disorder (PTSD). Since 2015, millions of Venezuelans have fled their country due to a severe humanitarian crisis, including extreme inflation, food shortages, and political unrest. Many of these individuals now live in Peru, where they struggle to access mental health services. A new type of intervention that is both evidence-based and culturally adapted to meet the specific needs of Venezuelan migrants is the focus of this research. The intervention is designed to be delivered by trained lay providers-people from the community who have received special training but are not professional mental health workers. The intervention consists of 6 to 12 weekly online sessions, each lasting about an hour. These sessions will cover various therapeutic techniques, including cognitive restructuring (changing negative thought patterns), behavioral activation (encouraging positive activities), and emotional regulation (managing feelings). The sessions will be conducted remotely, allowing participants to join from the comfort of their homes.This approach is intended to make mental health care more accessible and relatable for migrants, who may feel more comfortable receiving help from someone who understands their cultural background and experiences.
NCT03819608
This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +/- PTSD.
NCT06096740
The purpose of this study is to identify how trauma-focused psychotherapy changes the function of brain circuitry in posttraumatic stress disorder (PTSD) and how this mediates improvements in the diminished ability to experience positive emotions following a traumatic or extremely stressful life event. In this instance, the investigators will be using cognitive processing therapy (CPT), a widely-utilized and evidence-based treatment for PTSD.
NCT06139159
Latinos in the U.S. experience significant disparities in access to mental health services due to lack of health insurance, language barriers, low availability of bilingual providers, mental health stigma, and fear of deportation. There is an urgent need to identify low-cost, culturally appropriate interventions to reduce mental health disparities among this population. This project will address that need by implementing and testing CRISOL Mente, a multi-level, culturally-congruent community intervention to improve the mental health of the Latino population in Philadelphia.
NCT06834867
Intimate Partner Violence (IPV) is a major public health problem in low- and middle-income countries (LMICs). Globally, an estimated 30% of women report physical or sexual violence by an intimate partner in their lifetime. IPV is a well-established social driver of mental health problems, and doubles the rate of depression and post-traumatic stress disorder (PTSD). Interventions like cognitive behavioral therapy (CBT) can improve depression after women experiencing IPV exit abusive relationships. However, despite ongoing violence, many young women in LMICs are less likely to divorce or separate from their husband. But ongoing IPV severely limits mental health recovery and increases the risks of suicide. Another important factor in many LMICs is that young women often live in extended, multi-generational households, where studies have shown that mother-in-laws (MILs) play a critical role in young married women's autonomy and freedom of movement, substantially affecting her mental health. The pathways via which multiple family members and ongoing IPV affect young women's mental health in LMICs is very poorly understood. There is an urgent need to design and assess interventions that: a) improve mental health and reduce IPV; b) engage husbands and MILs, and not just women experiencing IPV; and c) elucidate pathways via which IPV-related drivers affect mental health. This study's research team, with over 16 years of experience in Nepal, conducted a pilot study introducing the Multi-component family Intervention to Lower depression and Address intimate Partner violence (MILAP). MILAP, which translates to "unity and reconciliation" in Nepali, showed promise in reducing depression and IPV among families (comprising women, husbands, and mothers-in-law). Based on these favorable results, the investigators now propose a 12-month randomized controlled trial (RCT) to assess the effectiveness of MILAP in addressing depression, IPV, and PTSD among young married women in Nepal. The goal of this RCT is to assess the effectiveness of MILAP, understand mechanisms of change for MILAP's effectiveness, and conduct a cost-effectiveness analysis. The specific aims of this study are: AIM 1: Conduct a 12-month RCT to assess the effectiveness of MILAP on depression, IPV, and PTSD among young married women in Nepal. AIM 2: Conduct a mixed-methods assessment of theorized mechanisms of change for MILAP's effectiveness. AIM 3: Conduct a cost-effectiveness analysis of MILAP for depression and IPV. Participants of this study will receive either MILAP or enhanced usual care, and will answer questions about depression, IPV and PTSD at baseline, at 1 month and every 3 months until 1-year.
NCT07288151
The goal of this clinical trial is to investigate the efficacy of 3,4-methylenedioxy-methamphetamine hydrochloride (MDMA) combined with Massed Prolonged Exposure (PE) therapy for the treatment of posttraumatic stress disorder (PTSD) in adult participants diagnosed with PTSD. This randomized, placebo-controlled trial will enroll 95 participants. The main questions it aims to answer are: * Does the combination of PE + MDMA lead to greater reduction in PTSD symptom severity from pre-treatment to one-month follow-up compared to PE + placebo? * Does PE + MDMA improve response efficiency and durability of PTSD symptom improvement compared to PE + placebo? * Does MDMA + PE enhance extinction retention and reduce amygdala threat reactivity, and are these changes associated with improved PTSD outcomes? Participants will: * Receive 10 sessions of Massed Prolonged Exposure therapy over two weeks * Be administered either 100 mg of MDMA or a placebo at Visit 2 * Undergo blinded independent evaluator assessments using the Clinician-Administered PTSD Scale for DSM-5-R (CAPS-5-R) at the one-month posttreatment follow-up
NCT07080606
The goal of this clinical trial is to learn if 8 sessions of brief exposure and exercise therapy works to treat Post Traumatic Stress Disorder (PTSD) in adults. This study will also learn if participants think brief exposure and exercise therapy is a good and doable treatment. and The main questions it aims to answer are: * Do participants find brief exposure and exercise an acceptable and feasible means of treatment for PTSD? * Does brief exposure and exercise decreases of the severity of PTSD symptoms? Participants will: * Complete weekly questionnaires for 10-14 weeks. * Attend 8 twice weekly exposure therapy and exercise sessions for 4 weeks.
NCT07118839
The study investigators are conducting the first randomized placebo-controlled trial of MDMA-assisted therapy with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of three once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The primary objective of the proposed project is to evaluate safety and clinical outcomes of MDMA-assisted therapy compared to identical psychotherapy with low dose ("active placebo") MDMA for the treatment of PTSD-AUD in military Veterans. The Primary Outcome measures, the Clinician Administered PTSD Scale (CAPS-5) and Inventory of Psychosocial Functioning (IPF), will evaluate changes in PTSD symptoms and psychosocial outcomes over time. Changes in drinking outcomes will also be evaluated (via the Timeline Followback, TLFB).
NCT07485231
This research study is conducted to better understand why women with post-traumatic stress disorder (PTSD) have higher risk of cardiovascular disease as they get older. This study looks at how trauma and PTSD affect blood vessels in young women by testing whether the dietary supplement beetroot juice might help improve the function of blood vessels in women suffering from PTSD.
NCT03874793
This study will examine the effects of psychotherapy as treatment for PTSD, and specifically how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and an active mind-body comparison comparison therapy.
NCT06947538
Less than 20% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive (stepped) interventions for PTSD. The adaptive intervention sequences a digital mental health intervention (DMHI) and brief trauma- and skills-focused treatments for PTSD. The selected treatments are brief and scalable and less burdensome to systems of care. These treatments are: web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), Brief STAIR, and Written Exposure Therapy (WET).
NCT07462312
This randomized controlled trial (RCT) will evaluate the effectiveness of a digital biofeedback-based intervention ("Mental Gym®") designed to reduce Posttraumatic Stress Disorder (PTSD) symptoms and improve mental health. The intervention combines daily HRV biofeedback exercises using a wearable device (Garmin watch), a dedicated mobile application, and weekly group guidance sessions. A delayed-intervention control group design will be used. To account for expected attrition and ensure a final sample of 60 participants, approximately 80 subjects will be recruited. Physiological and self-report data will be collected pre- and post-intervention, weekly during the intervention, and at follow-ups (3 months post-intervention). The study population consists of combat veterans diagnosed with PTSD.
NCT07457801
The purpose of this study is to compare the effectiveness of two different online education courses (Oxford-Online and Mind-Online) for preventing stress related conditions among paramedics who have been working during a period of COVID-19 occurrence in Singapore. The study aims to: * Compare the efficacy of a locally-adapted version of internet-delivered cognitive training for resilience (Oxford Online) to an existing educational online training (Mind Online) on depressive symptom severity * Compare the efficacy of Oxford Online to Mind Online for improving posttraumatic stress symptoms, resilience, general psychological distress, anxiety symptoms, social support, work engagement, and health-related quality of life Participants will: * Complete an online battery of baseline questionnaires * Be randomised to receive 6 modules of either Oxford Online or Mind Online, delivered once per week over a 6-week period * Complete the same online questionnaire battery immediately following the intervention, and again at the 6-month and 12-month follow up
NCT07351305
The investigators want to test a treatment for posttraumatic stress disorder (PTSD) especially designed for military veterans and service members with mild or moderate traumatic brain injuries (TBI) and PTSD. The treatment will include individual psychotherapy sessions to manage PTSD.
NCT07011940
The goal of this clinical trial is to learn if the Along With Me web-based intervention works to decrease posttraumatic stress symptoms and suicidal ideation among bereaved parents following pregnancy and early infant loss. It will also learn whether peer guides provide additional improvements on these outcomes. The main questions it aims to answer are: • Do people who receive Along With Me or Along With Me plus a Peer Guide compared to services as usual have lower posttraumatic stress symptoms and suicidal ideation than those who do not receive the intervention? Researchers will compare Along With Me and Along With Me plus a Peer Guide to services as usual (referrals made in the hospital setting) to see if Along With Me works to prevent and address posttraumatic stress symptoms and suicidal ideation. Participants will: * Receive access to a mobile app with approximately 10 therapeutic modules about how to manage grief and other symptoms. * Receive check-ins with a Peer Guide (in the Peer Guide condition only)
NCT07104916
The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG/EMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard "psychological support" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT).