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PTSD clinical trials

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NCT ID: NCT05890482 Recruiting - PTSD Clinical Trials

A Scalable, Community-based Program for War and Refugee Trauma

ITH
Start date: May 15, 2022
Phase: N/A
Study type: Interventional

In low and middle-income countries, access to state-of-the-art mental health care is often limited. Islamic Trauma Healing (ITH) is a manualized mosque-based, lay-led group intervention aimed at healing the individual and communal mental wounds of war and refugee trauma. The investigators will execute a hybrid effectiveness-implementation randomized controlled trial (RCT) of ITH versus delayed ITH to evaluate mental health effectiveness and ease of implementation.

NCT ID: NCT05883397 Recruiting - PTSD Clinical Trials

Enhanced Hippocampal Neuroplasticity for Surfacing of Inaccessible Traumatic Memories in Veterans With PTSD

Start date: May 25, 2023
Phase: N/A
Study type: Interventional

Hyperbaric oxygen therapy (HBOT) includes the inhalation of 100% oxygen at pressures exceeding one atmosphere absolute. HBOT has been applied worldwide, mostly for chronic non-healing wounds. Our team demonstrated that HBOT induced hippocampal neuroplasticity in veterans with long-standing treatment-resistant PTSD; this led to enhanced memory recovery and significant improvement in PTSD symptoms. Both physical activity, such as aerobic exercise, and cognitive training were shown to support neurogenesis in the hippocampus. Therefore, the current study aims to evaluate whether hippocampal training, induced by physical and cognitive training, will augment the hippocampal neuroplasticity effect of HBOT and further enhance recovery of inaccessible memories in veterans with PTSD. The protocol will include forty male veterans aged 25 to 60 years, with combat-associated PTSD and peritraumatic amnesia, who will receive either HBOT alone or HBOT and hippocampal training. The HBOT protocol will consist of 60 daily sessions, 90-minutes each, five days a week. Hippocampal training will combine physical and cognitive training 3 times per week, prior to HBOT sessions. Detailed psychological evaluation, anatomic and functional MRI, electroencephalogram and autonomic nervous system data will be obtained at baseline, and during and after treatment. The proposed study offers a new approach of biological treatment for memory manipulations. The findings will help elucidate the mechanism of PTSD-related memory impairment and is expected to contribute to the development of biological memory manipulations for treating PTSD and other memory-related conditions.

NCT ID: NCT05789329 Recruiting - PTSD Clinical Trials

Non-Inferiority Trial of TrIGR for PTSD

TrIGR/CPT
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Trauma-related guilt is common and impairing among trauma survivors, particularly among Veterans with posttraumatic stress disorder (PTSD). The investigators' work shows that a brief treatment targeting trauma-related guilt, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt and PTSD and depression symptoms. Whether TrIGR is no less effective than longer, more resource heavy PTSD treatments disseminated by by VA, like cognitive processing therapy (CPT), is the next critical question that this study will seek to answer. 158 Veterans across two VA sites will be randomized to TrIGR or CPT to evaluate changes in PTSD, depression, guilt and shame symptoms across the two treatments.

NCT ID: NCT05758987 Recruiting - PTSD Clinical Trials

Blended Treatment för PTSD: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy

Start date: March 10, 2023
Phase: N/A
Study type: Interventional

A Randomized Controlled Non-inferiority Trial testing if the new experimental Blended Trauma focused cognitive behavioral therapy (B-TF-CBT) for post traumatic stress disorder (PTSD), is non-inferior to gold standard control treatment Prolonged Exposure (PE). Research question and hypothesis Can the blended treatment yield outcomes non-inferior to face-to-face TF-CBT for patients with PTSD when applied in regular health care with regards to PTSD-symptoms, depression, anxiety, sleep problems, quality of life and general functioning? The hypothesis is that the Blended TF-CBT will be non-inferior to standard face-to-face TF-CBT for patients with PTSD, directly after treatment as well as at 12-months follow up. The study will be conducted at 3-6 outpatient clinics in Region Stockholm, Sweden.

NCT ID: NCT05755100 Recruiting - Clinical trials for Overweight and Obesity

I MOVE!+UP: Piloting an Integrated Weight Management Program for Veterans With PTSD

Start date: January 12, 2023
Phase: N/A
Study type: Interventional

This study seeks to test I MOVE!+UP, which integrates individual evidence-based psychotherapy for PTSD with behavioral weight management among Veterans with a Body Mass Index of at least 30 and meeting criteria for current PTSD. Participants will continue receiving routine primary care and psychiatric care management as indicated, in coordination with the I MOVE!+UP therapist. This study is being conducted to see whether I MOVE!+UP holds promise as a treatment for commonly co-occurring PTSD and high Body Mass Index. Participation will involve attending up to 16 psychotherapy visits that last approximately 1-2 hours over 6 months and attending 2 study assessment visits that last approximately 1-2 hours at enrollment and 6 months. Active participation will take up to approximately 6 months.

NCT ID: NCT05746572 Recruiting - PTSD Clinical Trials

MDMA Plus Exposure Therapy for PTSD

Start date: February 13, 2024
Phase: Phase 2
Study type: Interventional

Posttraumatic stress disorder (PTSD) is a debilitating disorder. While effective treatments exist, some patients fail to receive the full benefits. Alternative treatment approaches are needed. 3,4-methylenedioxymethamphetamine (MDMA) is a medicine associated with feelings of closeness and love for others, empathy, insightfulness, and feelings of peace or well-being. Recent research combining one or two doses of MDMA with psychotherapy has shown improvements in PTSD symptoms. For the present study, the researchers will investigate MDMA in combination with Prolonged Exposure therapy (PE), a gold-standard treatment for PTSD. All participants receive MDMA on the second day of a 10-day PE treatment program in which a PE therapy session occurs each day. This study will occur at the Emory Brain Health Center. Potential participants will be recruited via community advertising and mental health referrals. The research team will also collect psychophysiological data for exploratory analyses regarding how MDMA may improve PE treatment for PTSD. This is an important study as it is the first time MDMA will be combined with an evidence-based existing PTSD treatment. The study population will consist of people who meet the criteria for PTSD and are medically appropriate for MDMA administration.

NCT ID: NCT05734547 Recruiting - Quality of Life Clinical Trials

Stepping Together for Children After Trauma, Norway

NorStep
Start date: April 14, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to learn about how to effectively help children (aged 7-12) who have developed moderate symptoms of posttraumatic stress after exposure to trauma, and prevent development of more severe problems. The main research questions are: - Will the parent-led, therapist assisted treatment "Stepping Together for Children after Trauma" (ST-CT) be more effective, compared to usual care, in reducing symptoms of posttraumatic stress, depression and sleep disorders, and in improving daily functioning for children and their parents after trauma? - Is ST-CT implemented to the municipal first-line services cost-effective? - Will ST-CT prevent use of health care services and prescribed drugs in the long term? The children and their non-offending caregivers will be randomized to receive treatment with ST-CT or usual care, and symptoms and general functioning will be assessed at five time-points.

NCT ID: NCT05717439 Recruiting - Clinical trials for Major Depressive Disorder

Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults With PTSD

Start date: March 1, 2023
Phase:
Study type: Observational

The aim of this study is to obtain data on the feasibility of the Senseye Diagnostic Tool (DT) to assess the presence and severity of post-traumatic stress disorder (PTSD) symptoms. The study will also collect data on Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD) to aid in assessing the presence and severity of these disorders both for the purpose of discerning them from PTSD and determining the feasibility of diagnosing them independently.

NCT ID: NCT05709353 Recruiting - Clinical trials for Alcohol Use Disorder

MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder

MPATHY
Start date: September 19, 2023
Phase: Phase 2
Study type: Interventional

To explore the effectiveness of of MDMA-assisted prolonged exposure therapy in improving treatment outcomes for individuals with comorbid PTSD and alcohol use disorder in a double-blind randomised placebo-controlled trial.

NCT ID: NCT05701137 Recruiting - PTSD Clinical Trials

Effectiveness of an EMDR Intervention for Perinatal Loss

Start date: April 17, 2023
Phase: N/A
Study type: Interventional

The investigators objectives is to assess the effectiveness of Eye Movement Desensitization and Reprocessing - recent traumatic episode (EMDR-RTE) as a preventive intervention for Posttraumatic Stress Disorder (PTSD) symptoms after perinatal loss. The hypothesis is that EMDR-RTE treatment may prevent post-traumatic and depressive symptoms in women who suffered perinatal loss.