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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.
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.
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.
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.
NCT07251218
Ambient air temperatures in India have broken record highs. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions are susceptible to increased heat exposure. Heat exposure can instigate and worsen mental health. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote mental wellbeing in household occupants. The long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on mental health in Ahmedabad, India.
NCT06806267
A new method is being tested to assist individuals in Ukraine with Post-Traumatic Stress Disorder (PTSD), including veterans and civilians affected by war. The study is a collaboration among Ukrainian healthcare institutions and the Charité Berlin. What is PTSD? PTSD can occur after a distressing or traumatic experience, such as exposure to war. It can result in persistent negative memories, nightmares, heightened nervousness, or avoidance of reminders associated with the event. Purpose of the Study Two innovative treatments for PTSD are being tested: 1. Virtual Reality Therapy: This approach uses specialized goggles to create a safe and realistic virtual environment where individuals can confront memories and process emotions with guidance from a therapist. 2. Brain Stimulation Therapy (tDCS): This method applies a gentle electrical current to the scalp to support improved emotional regulation by the brain. The study aims to determine whether combining these two treatments is more effective than using virtual reality therapy alone. Participant Involvement Participants will: * Attend 10 therapy sessions over several weeks. * Use virtual reality goggles to engage with safe scenarios related to their memories, guided by a therapist. * Potentially receive brain stimulation therapy during some virtual reality sessions. * Learn relaxation techniques to help manage stress and enhance emotional control. Potential Benefits for Participants * These treatments may reduce symptoms such as intrusive memories, anxiety, and depression. * Participants may experience increased calmness, resilience, and improved ability to manage daily life. This study also has the potential to advance PTSD treatment methods for others in the future.
NCT07368166
Population-based and clinical studies indicate that a substantial proportion of children and adolescents are exposed to one or more potentially traumatic events (PTEs) Approximately 16 % of those affected by childhood trauma go on to develop post-traumatic stress disorder (PTSD), with an even higher proportion experiencing subclinical levels of post-traumatic stress symptoms (PTSS). In Switzerland, over half of adolescents report exposure to at least one PTE, with 4.2 % meeting diagnostic criteria for PTSD. PTSD frequently impacts young people's social and educational functioning, often impairing their ability to engage in everyday life activities that are important or meaningful to them. Although the psychological consequences of PTSD are well documented, there is limited empirical understanding of how PTSS specifically affects day-to-day functioning in young people. A key reason for this gap is the absence of a validated instrument specifically designed to assess PTSD-related functional impairment in children and adolescents. To address this need, the PTSD-iMPairment in Adolescent \& Children's Capacity for Thriving (PTSD-iMPACT) measure was developed. This tool aims to systematically assess the extent of PTSD-related functional impairment in children and adolescents across key life domains, such as family, friends, school, apprenticeship, hobbies or media use. The overall aim of this study is to evaluate the psychometric properties of the PTSD-iMPACT questionnaire in a clinical and in a non-clinical sample and to provide an internationally applicable standard instrument for the assessment of PTSD-related functional impairment in trauma-exposed children and adolescents. In the long term, the aim is to ensure that the care and support provided to children and adolescents who experience difficulties in their daily lives due to post-traumatic stress symptoms are sustainably monitored and improved.
NCT04806620
The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. "Healthy" individuals without brain inflammation are also eligible to participate. The digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.
NCT07336251
With this research investigators hope to begin to understand how rTMS can improve posttraumatic stress disorder (PTSD) symptoms. TMS improves PTSD through two interrelated mechanisms: change in brain limbic system function and change in systemic inflammatory activation. Participants who decide to join this study, will receive ten rTMS treatments. All participants will undergo a 40-minute rTMS procedure with a member of the study team 10 times over 2-4 weeks. Participants will undergo fMRI scans of the head in order to help researchers better understand potential effects of rTMS on brain activity. In addition, participants will be asked to give two breath and blood samples to look for signs of general inflammation.
NCT07187011
The purpose of this study is to test the drug PT150, which blocks glucocorticoid receptor (GR) signaling, for treatment of PTSD in Veterans, and establish a safety and efficacy profile that will inform the design of future studies.
NCT07285161
The primary outcome is quality of life, with secondary outcomes including PTSD symptoms, and psychosocial functioning. We hypothesise that a low-dose intervention based on empowerment and self-directed goal setting will lead to (a) measurable improvements in veterans' quality of life and (b) reduced PTSD symptoms, and improved psychosocial functioning.
NCT07069517
This study is a two-arm individually randomized group treatment clinical trial evaluating behavioral therapies for insomnia, nightmares, and PTSD. The study will compare cognitive-behavioral therapy for insomnia and nightmares to sleep hygiene (Control), both integrated with Written Exposure Therapy for PTSD and delivered in an accelerated (i.e., 5-day) group treatment format, preceded and followed by individual treatment sessions. 160 participants will be randomized into one of two study conditions.
NCT07052474
Post-Traumatic Stress Disorder (PTSD) in adolescents is a debilitating condition that, without timely intervention, risks becoming chronic and severely impairing development. Although evidence-based treatments such as Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Eye Movement Desensitization and Reprocessing (EMDR) are effective, they typically require weekly sessions over 6-9 months, which many adolescents struggle to complete. High dropout rates remain a significant clinical challenge. Intensive trauma-focused interventions have shown promising outcomes in adults, including rapid symptom reduction and improved retention. Inspired by a Dutch model, this project evaluates a Swedish adaptation of Korte Intensieve Traumabehandeling (KIT), which combines EMDR, elements of TF-CBT, physical activity, and parental support in a 5-day intensive treatment. This project is a pilot study to examine the feasibility, early effects, and practicality of intensive trauma-focused therapy. The pilot study is the first step toward planning a larger, controlled study in Swedish child and adolescent psychiatry. The following questions are included in the project: 1. Is intensive trauma-focused psychological treatment with EMDR, components of TF-CBT, combined with physical activity and a parent group a feasible, suitable, and acceptable treatment method for PTSD within Swedish child and adolescent psychiatry in terms of: 1. Therapists' ratings of whether they find the intensive trauma-focused treatment acceptable, appropriate, and feasible. 2. The number of patients who complete the treatment without dropping out 3. Patients' self-reported satisfaction with the treatment 4. The proportion of patients with "adverse effects" 2. Does intensive trauma-focused psychological treatment with EMDR, components of TF-CBT, combined with physical activity and a parent group for PTSD, lead to a decrease in symptoms in the expected direction in terms of: 1. PTSD symptoms 2. General mental health
NCT07159516
A total of 67 people were recruited from maternity units and social media to take part in the study. They first completed an online questionnaire, then filled out the CityBiTS measure, and finally took part in a diagnostic interview over the phone. The CityBiTS scores were compared to the results of the interviews using ROC curve analysis. We looked at how well the scores identified cases (sensitivity), correctly identified non-cases (specificity), and overall accuracy to find the best cutoff scores and see how these compared to other available methods.
NCT07137845
Veterans in Canada are twice as likely as the general population to experience chronic pain. This pain is often linked to post-traumatic stress disorder (PTSD), and both have a major impact on their quality of life. The autonomic nervous system (ANS) plays a key role in these pathologies, making its modulation a promising therapeutic target. Veterans are already experiencing pain and PTSD relief via virtual reality (VR), mostly through ANS reactivity modulation. Long-term exposure (desensitization) and the calming effect are the two forms of VR; the latter is more tolerable and more suited for ANS rebalance. Its benefits on pain, however, are still mild and transient. In order to further enhance these benefits, cranial nerve non-invasive neuromodulation (CN-NINM), a novel technology that enables the direct flow of neuronal impulses through tongue stimulation, is suggested to be combined with virtual reality (VR). The goal of this project is to document the feasibility of an intervention combining virtual reality (VR) with real and sham cranial nerve non-invasive neuromodulation (CN-NINM) in veterans with post-traumatic stress disorder and chronic pain. The secondary objectives are: 1) to explore and compare the effect of the two interventions (VR + real CN-NINM vs. VR + sham CN-NINM) on various clinical measures, and 2) to explore and compare the effect of these two interventions on autonomic nervous system (ANS) activity. Each intervention will be applied for 20 minutes. Their painful condition (whether diagnosed or not, type, location, intensity, and unpleasant aspects of the pain) as well as their PTSD-related symptoms will be assessed before and after the intervention. At the end of this study, it is expected that the CN-NINM could become a complementary treatment option for relieving pain and PTSD symptoms in PVs and, ultimately, improving their quality of life.
NCT07062042
Background: The Russian invasion of Ukraine has resulted in forced displacement, with over 80,000 Ukrainian refugees now residing in Norway. This displacement has led to increased vulnerability to trauma and mental health challenges. Narrative Exposure Therapy (NET), a short-term trauma-focused intervention, has demonstrated efficacy in reducing PTSD symptoms among individuals exposed to organized violence and war. Aim: The protocol aims to assess the clinical effects of Narrative Exposure Therapy (NET) on PTSD and depression symptoms among Ukrainian refugees in Norway and to facilitate training and supervised practice for Ukrainian health professionals and workers in using NET. Methods: This study employs a pretest-posttest randomized controlled experimental design. Ukrainian health professionals and workers in Norway will receive standardized NET training through a digital course. Subsequently, they will treat Ukrainian refugees using NET under supervision. Participants will be screened and assessed at three time points: baseline, immediately after treatment, and at 6-month follow-up. Validated questionnaires in Ukrainian and Russian will be used: PHQ-9, ITQ, LEC-5, SHUT-D, and demographic questionnaire. Exclusion criteria include active psychotic spectrum disorders, neurodevelopmental disorders and concurrent trauma therapy.
NCT07084233
The goal of this study is to measure the effects of Mindfulness-based Mind Fitness Training (MMFT) on anxiety, depression, post-traumatic stress disorder, sleep quality, and leadership.
NCT07121270
The goal of this randomized controlled trial is to pilot the virtual delivery of cognitive behavioral therapy for insomnia (CBT-I) and nightmares (CBT-I\&N) via telehealth as an early intervention for treating posttraumatic sleep disturbance in acute trauma patients exposed to interpersonal violence. The main aims are to: 1. Test the acceptability, feasibility, and satisfaction of sleep-focused CBT delivered early after trauma 2. Evaluate the impact of sleep-focused CBT delivered early after trauma on sleep disturbance 3. Evaluate the impact of sleep-focused CBT delivered early after trauma on PTSD symptoms The investigators will compare CBT-I and CBT-I\&N to sleep education control. Participants will meet with a provider for 6 weekly sessions via telehealth and complete surveys on the participants' symptoms.
NCT07106593
In this study, researchers are examining the best sequence of interventions for posttraumatic stress disorder (PTSD) and tinnitus. Participants will either receive psychotherapy for PTSD first (Cognitive Processing Therapy; CPT), followed by treatment for tinnitus (Cognitive Behavioral Therapy for Tinnitus; CBT-t); or vice-versa. We also aim to identify changes in brain functioning after receiving therapy.
NCT07107269
The gut microbiome has been shown to impact various facets of human health, including mental health. Studies have shown that populations with more agrarian lifestyles tend to have fewer chronic diseases and mental health issues than industrialized populations. A possible factor in these differences is the loss of co-evolved gut microbial taxa that has occurred with Westernization. This hypothesis, termed "Old Friends Hypothesis" suggests that the loss of certain gut microbes leads to immune dysregulation and increased chronic inflammation that contributes to development of cancers, cardiometabolic diseases and even neuroinflammation that can lead to negative behavioral and mental health outcomes. Other studies have shown that increasing the intake of plant foods may help increase diversity of the microbes in the gut and that this increased diversity could lead to better health outcomes in humans. The investigators propose to evaluate daily consumption of a drink consisting of a high diversity of plants (30 plant species) for four weeks on the diversity of the gut microbiome, biological signatures of inflammation, quality of life, sleep quality, and PTSD symptoms among persons with a diagnosis of PTSD. The investigators hypothesize that four weeks of daily consumption of this high plant diversity beverage (30 plant species) will increase gut microbiome ɑ-diversity, reduce markers of systemic inflammation, and improve PTSD symptom severity relative to daily consumption of a beverage containing only three plant species.