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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT06353282 Not yet recruiting - Adolescents Clinical Trials

MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents

Start date: July 1, 2025
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms.

NCT ID: NCT06345053 Recruiting - Clinical trials for Substance Use Disorders

Presence of PTSD and Emotion Dysregulation Among Inpatients With Substance Use Disorder

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

There are high rates of co-occurring posttraumatic stress disorder (PTSD) among patients receiving treatment for substance use disorder (SUD). PTSD and SUD should be treated simultaneously, but adults in SUD treatment are often not assessed for PTSD nor offered PTSD-based interventions. One of the reasons for reluctance in offering trauma focused treatment is increased risk of drop out. PTSD and related emotion dysregulation are related to elevated psychological burden, higher dropout rates and increased risk of relapse. this is a feasibility study, where the plan is to integrate a combination of Dialectical Behaviour Therapy for Substance Use Disorder (DBT-SUD skills) a therapy targeting difficulties in emotion regulation and Narrative Exposure Therapy (NET) a trauma focused therapy, for patients with co-occurring PTSD symptoms into standard SUD treatment . The plan is to assess its potential benefits by assessing whether adding this combination to standard SUD treatment is relevant, feasible, acceptable, and safe. Treatment outcomes are 1) Prevalence of PTSD, suicidal behaviour, and self-harm, as well as the severity of difficulties in emotion regulation and emotional avoidance among patients (N approx. = 100) in inpatient treatment for SUD. 2) Change post-treatment and at 3 and 12 months follow up, from baseline in PTSD symptom severity, depressive symptoms, emotion regulation, emotion avoidance, and experience of shame. 3) Rates of dropout and relapse compared to previous rates. This project can increase knowledge about psychological mechanisms in co-occurring PTSD and SUD and improve the quality of treatment for this vulnerable patient population.

NCT ID: NCT06341413 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder

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

The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth. Participants will attend 4 study visits: - A clinical and trauma assessment visit - A testing day that may include cognitive testing, surveys, and an MRI. - An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition - An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition

NCT ID: NCT06335589 Not yet recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Adapting Treatment Delivery to Improve Retention in Evidence-Based PTSD Treatment

Start date: June 17, 2024
Phase: N/A
Study type: Interventional

Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment).

NCT ID: NCT06335407 Not yet recruiting - Clinical trials for Alcohol Use Disorder (AUD)

Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study

Start date: April 29, 2024
Phase: Phase 1
Study type: Interventional

The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) in an outpatient setting and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials.

NCT ID: NCT06332209 Not yet recruiting - Clinical trials for Post-Traumatic Stress Disorder

Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico

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

The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery.

NCT ID: NCT06318195 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care.

CiPE
Start date: March 2024
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment.

NCT ID: NCT06310109 Recruiting - Depression Clinical Trials

Effect of Pediatric Intensive Care Unit Diaries on PICS-p

PICS-p
Start date: July 14, 2021
Phase: N/A
Study type: Interventional

When children become very sick and need to stay in a Pediatric Intensive Care Unit (PICU), it can have a big impact on their recovery and their family's well-being. Sometimes kids and their families feel worried or sad even after they leave the hospital. This can have an impact on the quality of their life after hospital discharge. To help understand and improve these experiences, the investigators want to study the "PICU diaries." These are journals that families and hospital staff can write in during the child's time in the hospital. Parents, other visitors and healthcare professionals can share thoughts, experiences, and even drawings or photos related to the child's admission. The content is a narrative account of what happens during the child's hospital stay, for the family to take home at PICU discharge. The investigators believe that writing in these diaries might help children and their families feel better after leaving the hospital. It might help kids feel less worried or sad, and it might also help their parents or caregivers feel better too. The study will include children who have been in the PICU and their families. Some families will receive these special diaries to use during their time in the hospital, while others won't. We'll then see how everyone feels after they leave the hospital and compare the two groups to see if the diaries make a difference. The investigators hope that by understanding how these diaries can help, healthcare professionals can make hospital experiences better for everyone involved.

NCT ID: NCT06303648 Recruiting - Clinical trials for Post Traumatic Stress Disorder

A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects

Start date: March 20, 2024
Phase: Phase 1
Study type: Interventional

This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.

NCT ID: NCT06296030 Withdrawn - Anxiety Clinical Trials

Culturally Tailored ACT for Black Trauma

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Blacks in America more frequently meet the criteria for posttraumatic stress disorder (PTSD) than any other US race or ethnicity. Yet, blacks are among the groups least likely to use mental health services for trauma. Thus, a large number of traumatized blacks suffer silently and remain untreated. Acceptance and Commitment Therapy (ACT) is an empirically-based psychological intervention that uses acceptance and mindfulness strategies, with commitment and behavior change strategies, to increase psychological flexibility and decrease anxiety outcomes. While culturally tailored mental health interventions have been shown useful for racial and ethnic minorities, there have been few efforts to tailor ACT for blacks. This NIH R21 would compare an ACT model specifically culturally tailored for blacks (POOF) to the classic ACT model in a randomized trial, where clinicians will conduct 12-session telehealth synchronous virtual groups. Eighty black participants who self-identify as suffering from stress or anxiety will be confidentially recruited. Two specific aims are proposed: Aim 1) It is expected that POOF participants will report higher levels of acceptability of treatment than classic ACT participants and that POOF participants will have better adherence to treatment regimens than traditional ACT participants. Aim 2) Given that race-based stress may mediate anxiety symptoms in U.S. based blacks, it is expected that POOF will decrease race-based stress, thereby mattering the most for improving anxiety outcomes for blacks. The proposed R21 pilot study will be the first randomized controlled trial to evaluate an ACT intervention tailored explicitly for black racial trauma. This study will provide critical data needed to plan and design a future R01 controlled longitudinal effectiveness study. The long-term objective is to significantly reduce the prevalence of stress and anxiety-related symptoms due to traumatic events for Blacks by increasing treatment acceptability for this population. Since blacks have the highest rates of trauma prevalence and chronicity, yet they are still underrepresented in mental health treatment, this tailored intervention can have a significant public health impact.