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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT05223829 Recruiting - Clinical trials for Alcohol Use Disorder

Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder

Start date: August 1, 2023
Phase: Phase 1
Study type: Interventional

For this protocol, the investigators plan to collect pilot data to: 1. establish the feasibility and safety of administering brexanolone to individuals with concurrent Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD).

NCT ID: NCT05220137 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy

CPT MOST
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Cognitive Processing Therapy (CPT) consists of discrete therapeutic components that are delivered across 12 sessions, but most Veterans never reach session 12, and those who drop out receive only 4 sessions on average. Veterans drop out because of time constraints, logistics, and lack of perceived benefit. Unfortunately, Veterans who drop out prematurely may never receive the most effective components of CPT and continue to experience symptom-related distress and numerous other negative outcomes, including lost productivity, substance use, later-life physical disability, reduced quality of life, and increased risk of suicide. The overall objective of this study is to adapt CPT into a brief, effective format. The rationale is that identifying the most effective intervention components and delivering only those components will make CPT deliverable in a shorter timeframe, thus improving efficiency, reducing drop-out related to poor treatment response, and ensuring that Veterans receive the most beneficial components of treatment, which will significantly improve their quality of life.

NCT ID: NCT05219175 Active, not recruiting - Clinical trials for Stress Disorders, Post-Traumatic

MDMA for Co-occurring PTSD and OUD After Childbirth

Start date: April 16, 2024
Phase: Phase 2
Study type: Interventional

This is an open-label study of the use of MDMA Assisted Therapy for postpartum people with co-occurring Post Traumatic Stress Disorder (PTSD) and Opioid Use Disorder (OUD). The study protocol has been adapted from the Phase 3 studies sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) for PTSD. Due to the high rate of concurrence of PTSD and OUD, people with OUD may experience great benefit from the treatment of their PTSD with MDMA-assisted therapy based on the phase 2 and 3 studies for PTSD. Use of MDMA-assisted therapy in this population has the potential to be of benefit for their OUD and maternal- infant attachment. This study will serve to explore the feasibility and safety of offering MDMA-assisted therapy for treatment of PTSD in postpartum people with opioid use disorder. The CAPs 5 (PTSD) is the primary outcome, the Timeline Follow-Back (TLFB) for opioid use is the secondary outcome and other assessments of opioid use disorder, effects on maternal-infant attachment, social connectedness and other mental health outcomes are exploratory. The study will be conducted at the University of New Mexico Health Sciences Center located in Albuquerque New Mexico. In addition to northern New Mexico being an epicenter of the current opioid use disorder epidemic in the United States there is a long-standing history of multigenerational use of illicit opioids in many communities of northern New Mexico. There are high rates of opioid use disorder on pregnancy and accompanying Neonatal Opioid Use Withdrawal Syndrome (NOWS) in Albuquerque, Santa Fe, and surrounding communities.

NCT ID: NCT05218031 Not yet recruiting - Depression Clinical Trials

Acceptance and Commitment Group Therapy for Unaccompanied Minors

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Unaccompanied minors (UM) are considered to be a highly vulnerable refugee subgroup. Research has indicated that UM experience traumatic events and consequently develop high levels of psychopathology. Post-traumatic stress disorder is the most prevalent diagnosis, followed by depression, anxiety disorders as well as traumatic grief and conduct problems. Acceptance and Commitment Therapy (ACT) may be particularly suited to the treatment of survivors of trauma and with vulnerable refugee groups such as UM. A 5-week ACT group intervention will be carried out and its feasibility in UM will be explored along with its effect on mental health. The ACT group intervention will be based on a Self-Help Booklet by the World Health Organization "Doing What Matters in Times of Stress: An Illustrated Guide". Following the 5-week ACT group intervention, focus groups with participants will be carried out to examine its acceptability and will be analysed qualitatively, using thematic analysis.

NCT ID: NCT05213858 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Biological Markers for Post-Traumatic Stress Disorder

Start date: January 1, 2022
Phase:
Study type: Observational

The current study aims to evaluate the sensitivity and specificity of a combination of various objective biomarkers for the diagnosis of PTSD.

NCT ID: NCT05212714 Completed - Clinical trials for Stress Disorders, Post-Traumatic

taVNS to Reduce PTSD Symptoms in WTC Responders

taVNS
Start date: March 31, 2022
Phase: N/A
Study type: Interventional

This study seeks to conduct a randomized, double-blind pilot study, to determine whether the Transcutaneous Auricular Vagus Nerve Stimulation and study procedure are feasible and acceptable for use with World Trade Center responders with Post Traumatic Stress Disorder.

NCT ID: NCT05207462 Completed - Clinical trials for Post Traumatic Stress Disorder

A Feasibility Study of Intensive Treatment With Prolonged Exposure

Start date: January 24, 2022
Phase: N/A
Study type: Interventional

The primary objective with this study is to investigate the feasibility and acceptability of intensive treatment with prolonged exposure (I-PE) in regular Swedish psychiatric care. The secondary objective is to investigate preliminary effects of i-PE in terms of reducing symptoms of post-traumatic stress, depression and increase quality of life.

NCT ID: NCT05207436 Completed - Clinical trials for Post Traumatic Stress Disorder

Brief Cognitive Behavioral Conjoint Therapy for PTSD With Adjunctive Intranasal Oxytocin

CBCT+OT
Start date: January 17, 2022
Phase: Phase 2
Study type: Interventional

In 2019 VA mandated that all Veterans seeking mental health care have access to flexible family mental health services in VA (VHA directive 1163.04). This study aims to respond to this mandate by further improving an evidence-based PTSD treatment designed to decrease PTSD symptoms and improve relationship satisfaction for Veterans and their romantic partners. Brief Cognitive-Behavioral Conjoint Therapy (B-CBCT), an 8-session dyadic psychotherapy for PTSD, has been found to significantly reduce PTSD symptoms, but the effects of B-CBCT on relationship satisfaction are less reliable and robust. Pharmacological augmentation of psychotherapy utilizing intranasal oxytocin, a neurohormone that influences mechanisms of trauma recovery and social behavior, may help improve relationship satisfaction outcomes. If successful, the proposed study will advance knowledge of strategies for improving Veterans' quality of life by improving their intimate relationships along with PTSD symptoms.

NCT ID: NCT05206734 Completed - Schizophrenia Clinical Trials

Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health

Start date: January 5, 2022
Phase:
Study type: Observational

This study is a large population-based analysis in the United Kingdom (UK) using routine primary care data to investigate the risk of mental health conditions in children, adolescents and young adults with Inflammatory Bowel Disease, compared to those without Inflammatory Bowel Disease. The study will also compare the impacts on quality-of-life outcomes and use of healthcare services between people with Inflammatory Bowel Disease with and without mental health conditions.

NCT ID: NCT05195684 Completed - Clinical trials for Posttraumatic Stress Disorder

MGH Trauma-related Nightmares SDI Study

NM
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Interested individuals will first complete a telephone screening followed by a series of structured clinical interviews to diagnose PTSD and comorbid psychiatric disorders, confirm initial inclusion criteria, rule out exclusion criteria and create an audio-recorded account of their index trauma. Participants passing screenings will then complete 2 weeks of at-home sleep and nightmare diaries and time-stamped audio-recorded reports of dream content upon awakening from any nightmare. They will also wear a wrist actigraph throughout this period, complete 2 nights of ambulatory PSG, and complete on-line questionnaires. Nightmare data will be examined for frequency and thematic similarity of nightmares to a participant's reported index trauma. Participants' nightmare and index trauma reports will be audio-recorded for use as scripts during SDI. The participant will then undergo two SDI sessions on a single day, one with a nightmare script and one with an index-trauma script, during which they will wear the NINscan. Sessions will be separated by 1 hour and counterbalanced across participants for script order.