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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT03868930 Completed - Depression Clinical Trials

Multisite RCT of STEP-Home: A Transdiagnostic Skill-based Community Reintegration Workshop

STEP-Home
Start date: June 17, 2019
Phase: N/A
Study type: Interventional

In this proposal, the investigators extend their previous SPiRE feasibility and preliminary effectiveness study to examine STEP-Home efficacy in a RCT design. This novel therapy will target the specific needs of a broad range of underserved post-9/11 Veterans. It is designed to foster reintegration by facilitating meaningful improvement in the functional skills most central to community participation: emotional regulation (ER), problem solving (PS), and attention functioning (AT). The skills trained in the STEP-Home workshop are novel in their collective use and have not been systematically applied to a Veteran population prior to the investigators' SPiRE study. STEP-Home will equip Veterans with skills to improve daily function, reduce anger and irritability, and assist reintegration to civilian life through return to work, family, and community, while simultaneously providing psychoeducation to promote future engagement in VA care. The innovative nature of the STEP-Home intervention is founded in the fact that it is: (a) an adaptation of an established and efficacious intervention, now applied to post-9/11 Veterans; (b) nonstigmatizing (not "therapy" but a "skills workshop" to boost acceptance, adherence and retention); (c) transdiagnostic (open to all post-9/11 Veterans with self-reported reintegration difficulties; Veterans often have multiple mental health diagnoses, but it is not required for enrollment); (d) integrative (focus on the whole person rather than specific and often stigmatizing mental and physical health conditions); (e) comprised of Veteran-specific content to teach participants cognitive behavioral skills needed for successful reintegration (which led to greater acceptability in feasibility study); (f) targets anger and irritability, particularly during interactions with civilians; (g) emphasizes psychoeducation (including other available treatment options for common mental health conditions); and (h) challenges beliefs/barriers to mental health care to increase openness to future treatment and greater mental health treatment utilization. Many Veterans who participated in the development phases of this workshop have gone on to trauma or other focused therapies, or taken on vocational (work/school/volunteer) roles after STEP-Home. The investigators have demonstrated that the STEP-Home workshop is feasible and results in pre-post change in core skill acquisition that the investigators demonstrated to be directly associated with post-workshop improvement in reintegration status in their SPiRE study. Given the many comorbidities of this cohort, the innovative treatment addresses multiple aspects of mental health, cognitive, and emotional function simultaneously and bolsters reintegration in a short-term group to maximize cost-effectiveness while maintaining quality of care.

NCT ID: NCT03846323 Completed - Clinical trials for PTSD in Family Members of ICU Patients

Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder

OPEN-UNIT
Start date: April 18, 2009
Phase: N/A
Study type: Interventional

This was a cluster randomized study of an ICU level intervention to reduce high risk of post-traumatic stress disorder (PTSD) in family members of ICU patients. Participating ICUs had restrictive visiting policies (i.e., <6 hours/day) before randomization. After an observational period and a washout period, participating ICUs were randomized either to maintain their visiting policies or to liberalize their visiting policies (24 hours a day, 7 days a week.)

NCT ID: NCT03846154 Completed - Clinical trials for Posttraumatic Stress Disorder

Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Mental Health Symptoms

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Children living at the landfills of Bujumbura are often exposed to maltreatment, including emotional neglect and physical abuse, and traumatic experiences. Furthermore, they grow up in severe poverty. Addressing trauma-related mental health issues and aggressive behaviour by Narrative Exposure Therapy (FORNET), familial communication by family visits, interaction difficulties of children by a group intervention, poverty by financial support and economic training for mothers, medical problems by medical assistance, legal conflicts by legal advice, and providing access to school, we aimed at reintegrating those children within the Burundian school system and improving familial relationships. The investigators want to provide evidence, that mental health interventions are an integral part of assisting children and families affected by poverty and violence.

NCT ID: NCT03845985 Completed - Clinical trials for Alcohol Use Disorder

Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma

Start date: June 3, 2019
Phase: N/A
Study type: Interventional

The U.S. Deaf community - more than 500,000 Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure as compared to the general population. Although there are validated treatments for alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) in hearing populations, there are no evidence-based treatments for any behavioral health condition that have been validated for use with Deaf clients. To address these barriers, the study team has developed "Signs of Safety", a Deaf-accessible therapy toolkit for treating AUD and PTSD. The study team's ongoing aims are to conduct a two-arm pilot RCT of "Signs of Safety" and to collect data on feasibility, preliminary clinical outcomes, and potential mediators and moderators of outcome.

NCT ID: NCT03840369 Completed - Clinical trials for Stress Disorders, Post-Traumatic

Pathophysiological Understanding and Treatment of PTSD: an rTMS Approach

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

In Canada, the prevalence of PTSD is approximately 12%, similar to Canadian military personnel. Current treatments for PTSD are limited in efficacy and durability - indicating a dire need for novel interventions in this population. Transcranial magnetic stimulation (TMS) has a high degree of safety and has been studied as an intervention for many mental health and neurological conditions; even showing initial promise for PTSD. We propose to study this further in a randomized sham controlled trial of TMS for PTSD.

NCT ID: NCT03833531 Completed - Clinical trials for Posttraumatic Stress Disorder (PTSD)

Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and CPD

PROSPER-C
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The goal of PROSPER-C is to study effectiveness of ImRs compared to integrated SFT-ImRs in treatment-seeking, adult patients with comorbid PTSD and Cluster C Personality Disorder (CPD).

NCT ID: NCT03822598 Completed - Depression Clinical Trials

Promoting Asylum-seeking and Refugee Children's Coping With Trauma

Start date: June 20, 2017
Phase: N/A
Study type: Interventional

A short term trauma-focused cognitive- behavioral program to reduce trauma-related mental health problems among asylum-seeking and refugee children. The main hypothesis of the study is that the TRT program significantly improves mental health (i.e. reduces symptoms of post-traumatic symptoms, depression and generalized anxiety and increases perceived quality of life (Qol) in the intervention group compared to the waiting-list control group.

NCT ID: NCT03821259 Completed - Clinical trials for Post Traumatic Stress Disorder

Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life

Start date: November 6, 2018
Phase:
Study type: Observational

Older adults are becoming a growing proportion of people utilising mental health services. However, the needs of this population are poorly understood despite the evidence that mental health conditions are manifested differently in old age. One of those conditions is Post Traumatic Stress Disorder (PTSD) which has been associated with an increased risk of adverse outcomes in old age, including health problems, difficulties in daily functioning, less satisfaction with life and multiple psychiatric co-morbidities, such as depression and anxiety. Despite the serious consequences, PTSD symptoms in old age tend to be underreported or misperceived as a physical illness or part of an ageing process. Traumatic life experiences do not necessarily lead to PTSD. Psychological resources, including emotional stability and social support, allow individuals to find appropriate coping strategies and maintain well-being in old age. Group identification, defined as a sense of belonging to a specific group, influences the response to social support and may be important in predicting distress in old age. On the other hand, socioeconomic deprivation is likely to increase this distress as exposure to traumatic events is more prevalent in disadvantaged populations. The present study will investigate the impact of those factors on PTSD symptoms in later life. The researcher will recruit 85 older adults from the Older People Psychological Therapies Service, who are in receipt of psychological treatment for PTSD, anxiety or depression. Participants will be asked to provide basic demographic information, which will be used to describe the participant characteristics and to estimate the degree of socioeconomic deprivation. Participants will also complete five measures to screen for cognitive impairment and measure PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification. The findings will help improve the diagnostic process and development of psychological treatments for PTSD in older adults by expanding our knowledge of this condition in later life.

NCT ID: NCT03818425 Completed - Exercise Clinical Trials

Motivation and Barriers for Exercise in Patients With Anxiety or Posttraumatic Stress Disorder

Start date: January 7, 2019
Phase:
Study type: Observational

Relevance and Aim: There has been increasing research interest in sport preferences and motivational factors as well as barriers that restrain from engaging in sport activities in people suffering from mental illnesses. Anxiety disorders are one of the leading mental disorders worldwide. Exercise has previously shown anxiolytic effects and is discussed as an adjunctive treatment option in clinical practice. This study aims to depict motivation and barriers in patients with anxiety or posttraumatic stress disorders. Design and Participants: Observational study of patients diagnosed with anxiety disorder or posttraumatic stress disorder (ICD-10) Measurements: Structured questionnaire compounded of validated scales for current physical activity, sport motivation, exercise preferences, perceived barriers , self-efficacy, social support for physical activity, motivation,enjoyment, quality of life as well as sociodemographic data. Duration: The questionnaire will require approximately 20 minutes, the overall duration is 3 months. Personal assistance for completing the questionnaire will be provided if necessary.

NCT ID: NCT03816007 Completed - Clinical trials for Chronic Low Back Pain

Yoga and Mantram for Chronic Pain and PTSD

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

PTSD is prevalent among Veterans and is associated with physical and functional impairments in addition to PTSD symptoms. Veterans with PTSD experience more chronic pain and pain-related functional limitations than Veterans without PTSD. Mind-body interventions such as yoga and meditation are non-pharmacological options for treating both chronic pain and PTSD. This pilot study will add an existing mantram repetition (MR) component designed for Veterans with PTSD to an active yoga intervention known to improve function in chronic back pain patients. The study will examine the acceptability of the interventions, adverse events, and the feasibility of recruitment, attendance, retention, treatment fidelity, and assessments by recruiting and randomizing 32 VA patients with PTSD to either yoga plus MR or to a relaxation/health education control. Health outcomes including pain-related function, pain, and PTSD symptoms will be measured. If feasible, the data will be used to plan a full-scale trial of enhanced yoga for pain in VA patients with PTSD.