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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT05616286 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Mindfulness-SOS for Refugees

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

Worldwide, refugees and asylum seekers suffer at high rates from trauma and stress-related mental health problems. The research group therefore developed, and initially piloted in a single-site open trial, a novel mindfulness- and compassion-based digital intervention program - Mindfulness-SOS for refugees (Mindfulness-SOS). The pilot study had promising preliminary findings of utilization, feasibility and related dose-response effects of intervention program engagement with mental health outcomes. The digital intervention program was developed based on randomized control trial data of a group-based mindfulness- and compassion-based program for forcibly displaced people. To address common limitations of mobile health interventions such as attrition, engagement and adherence, the investigators will implement a personalized stepped-care adaptation and augmentation of Mindfulness-SOS, that entails providing intensified (remote) guidance for FDPs that do not respond to the intervention, to optimize capacity to therapeutically benefit from Mindfulness-SOS. To do so, the investigators propose to carry out a randomized controlled Sequential Multiple Assignment Randomized Trial (SMART) study to test and optimize the therapeutic outcomes of Mindfulness-SOS, using an adaptive intervention sequence of guidance format intensities among N ≅ 170 (50% female) adult trauma-affected Eritrean asylum-seekers residing in Israel.

NCT ID: NCT05606172 Recruiting - Clinical trials for Post-traumatic Stress Disorder

Adaptation of the PCIP for Children Aged 6 to 11

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

This study will implement a brief Post-traumatic Stress Disorder (PTSD) intervention for children, the Primary Care Intervention for PTSD (PCIP) delivered through telehealth (computer or smartphone delivery), to 10 youth age 6-11 and their caregivers. Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control) to refine the intervention, study procedures, and explore effectiveness. Following RE-AIM guidelines, the investigators will assess: 1. Reach: patient participation in intervention delivery (out of all those asked to participate) and retention rate (out of all those who consented to participate and completed at least two intervention sessions) 2. Adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings. To understand patient experiences with the intervention and to identify and explain positive or negative treatment mechanisms or effects, the investigators will conduct post-intervention semi-structured interviews with the participating patients, their parents/guardians, and with providers. This treatment ranges from 1-4 sessions which last 50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the parent or both the parent and child. The first session will also teach the parent and child a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the child's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that the parent and child can learn together. There is also material for parents to address behavior problems in youth. This treatment will be delivered via telehealth.

NCT ID: NCT05604794 Completed - Depression Clinical Trials

A Retrospective Effectiveness Trial of Ketamine-Assisted Psychotherapy in Adult Patients Coping With Mental Health

Start date: March 13, 2020
Phase: Phase 4
Study type: Interventional

Ketamine-Assisted Psychotherapy (KAP) is a relatively new approach for the treatment of mental health issues, which involves the combination of ketamine, a dissociative anaesthetic with psychedelic properties, and psychotherapy to promote emotional wellbeing. In this study, we investigated the effectiveness of KAP in adult patients coping with mental health. We predicted that clients would experience lasting reductions in psychological distress over time, such as depression, anxiety, and post traumatic stress, that would be detectable up to 6 months after treatment. The results of this study may provide evidence of sustained real-world effects of Ketamine-Assisted Psychotherapy, of interest to patients, clinicians, researchers, and policymakers.

NCT ID: NCT05598099 Recruiting - PTSD Clinical Trials

Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study

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

Post-traumatic stress disorder (PTSD) is a prevalent and disabling condition. Trauma-focused psychotherapy, including cognitive behavioural therapy (CBT), are among the recommended first-line treatment alternatives. However, a substantial proportion of patients decline, drop-out or do not respond to current psychotherapies. Previous research suggests that intensive or concentrated formats of trauma-focused psychotherapy can lead to faster recover and lower attrition, but there are currently few studies of these approaches. The current study will investigate the acceptability. treatment satisfaction and preliminary changes in symptoms after four consecutive days of concentrated CBT for PTSD.

NCT ID: NCT05596903 Completed - Clinical trials for Post Traumatic Stress Disorder

Effect of Eye Movement Desensitization and Reprocessing Therapy 2.0 Online Group Protocol

Start date: October 14, 2022
Phase: N/A
Study type: Interventional

In this study, it will be investigated the efficacy of Eye Movement Desensitization and Reprocessing Therapy 2.0 Online Group Protocol on post-traumatic symptoms compared to control group. Therefore, the randomized control trial is based on Eye Movement Desensitization and Reprocessing Therapy 2.0 group as an intervention.

NCT ID: NCT05592652 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Identification of the Clinical Specificities of Complex Posttraumatic Stress Disorder

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

Identification of the clinical specificities of complex post-traumatic stress disorder post-traumatic stress disorder

NCT ID: NCT05591625 Recruiting - Critical Illness Clinical Trials

Eye Movement Desensitisation and Reprocessing (EMDR) to Improve Mental Health Following Intensive Care Admission

EMERALD
Start date: February 20, 2023
Phase: N/A
Study type: Interventional

The goal of this multi-centre, randomised, pilot feasibility study is to assess the feasibility of recruiting intensive care survivors, with symptoms of traumatic stress, to a study evaluating the use of eye movement desensitisation and reprocessing (EMDR). The main purpose is to determine whether it is feasible and acceptable to patients, clinicians and researchers. In addition, this study aims to identify design criteria that may be of use in a subsequent randomised controlled trial of clinical effectiveness. Participants will: - be recruited at hospital discharge - undergo a psychological assessment at 2-3 months post-hospital discharge - Those exhibiting symptoms of post-traumatic stress disorder (PTSD), will be randomised (1:1) to receive either usual care or usual care plus EMDR - Participants who do not exhibit PTSD symptoms at the 2-3 month assessment will enter a light-touch observation arm. - All participants will repeat the psychological assessment 12-months after hospital discharge. Feasibility parameters; recruitment, adherence, retention and safety data. Primary clinical outcomes; change in PTSD symptoms between 2-3 months and 12-months. The investigators will undertake a qualitative process evaluation using clinical ethnography and reported according to the Theoretical Framework of Acceptability.

NCT ID: NCT05579717 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Examining EAL for PTSD

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

This RCT will evaluate the efficacy of Equine Assisted Learning for reducing PTSD symptoms in public safety personnel (e.g., fire fighters, police, nurses, etc.).

NCT ID: NCT05569915 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Project QueST 2023: Queer Survivors of Trauma

QueST2023
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

This study aims to test the initial efficacy of tailored online writing interventions specifically designed for sexual minority women, transgender individuals, and/or nonbinary people to target the primary outcomes: posttraumatic stress disorder (PTSD) symptom severity and hazardous drinking.

NCT ID: NCT05568342 Completed - Clinical trials for Stress Disorders, Post-Traumatic

The Effect of Roy Adaptation-Based Nursing Intervention

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

Abstract Objective: The research was conducted to determine the effect of the nursing intervention, which was given to patients according to the Roy Adaptation Model, on patients' stress, psychosocial adjustment, and self-care power. Methods: The population of the study, which was conducted as a randomized controlled experimental study, consisted of 80 patients receiving outpatient dialysis treatment in the hemodialysis unit of a university hospital. The patients from the population were included in the sample of the study in a randomized manner. The data were collected using the Descriptive Characteristics Form, the Hemodialysis Stressor Scale, the Self-Care Scale, and the Psychosocial Adjustment to Illness Scale. Results: When the pre-tests between the groups were compared, hygienic self-care power, healthcare orientation, vocational environment, domestic environment, sexual relationships, extended family relations, social environment and total psychosocial adjustment levels changed significantly (p<0.05). When the post-tests were compared between the groups, no significant difference was found only in the mean of the mental state sub-dimension (p>0.05). Conclusion: Interventions made according to the Roy Adaptation Model reduced the stress level of the patients, and increased their self-care power and psychosocial adjustment. Keywords: Hemodialysis, Roy Adaptation Model, Stress, Self-Care Power, Psychosocial Adjustment