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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT03833531 Recruiting - 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: NCT03833453 Recruiting - Clinical trials for Posttraumatic Stress Disorder (PTSD)

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

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

The goal of PROSPER-B is to study effectiveness of EMDR compared to integrated DBT-EMDR in treatment-seeking, adult patients with comorbid PTSD and Borderline Personality Disorder (BPD).

NCT ID: NCT03828656 Enrolling by invitation - Clinical trials for PostTraumatic Stress Disorder

NightWare Open Enrollment Study

NWOES
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

This study will provide measures of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with the NightWare digital therapeutic system. The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related nightmares and poor sleep quality.

NCT ID: NCT03827057 Not yet recruiting - Clinical trials for Traumatic Brain Injury

RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder (RECONTROLPTSD)

RECONTROL PTSD
Start date: March 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspective) to make it less impactful, and reduce nightmares, flashbacks, and other features of PTSD. The memory is reviewed in the context of an imaginal movie theater, presenting a fast (~45 sec) black and white movie of the trauma memory, with further adjustment as needed so the patient can comfortably watch it. Open and waitlist studies of RTM have reported high response rates and rapid remission, setting the stage for this randomized, controlled, single-blind trial comparing RTM versus prolonged exposure (PE), the PTSD therapy with the strongest current evidence base. The investigators hypothesize that RTM will be non-inferior to PE in reducing PTSD symptom severity post-treatment and at 1-year follow up; will achieve faster remission, with fewer dropouts; will improve cognitive function; and that epigenetic markers will correlate with treatment response. The investigators will randomize 108 active or retired service members (SMs) with PTSD to ≤10 sessions of RTM or PE, affording power to test our hypotheses while allowing for ≤ 25% dropouts. The investigators will use an intent to treat analysis, and the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, or DSM5 (CAPS-5), conducted by blinded assessors, will be the primary outcome measure. Secondary measures of depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100), will be assessed pre- and post-treatment, and at 2, 6, and 12 months. ANOVA will compare symptom severity over time within and between groups. Blood draws will be obtained pre- and posttreatment to assess predictors of treatment response and epigenetic markers of change. The NIH Toolbox Neurocognitive Assessment, pre- and post-treatment, will assess impact on cognitive function. The investigators will track comorbid TBI, anticipating it will not adversely impact response. More palatable and effective therapies for PTSD, with and without TBI, must be developed and evaluated. RTM is safe and promising, but requires testing against evidence-based interventions in well-designed randomized clinical trials (RCTs). Demonstrating corresponding biomarker and neurocognitive improvements will corroborate results, and may facilitate more tailored treatment approaches in the future.

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 Recruiting - Anxiety Disorders Clinical Trials

What Factors Influence the Experience of Distress 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 distress in old age. 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 to determine their likely level of socioeconomic deprivation. They will also complete six measures to screen for cognitive impairment and measure symptoms of anxiety, depression and PTSD, as well as 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 distress in old age.

NCT ID: NCT03819608 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Neuromodulation and Neurorehabilitation for mTBI Plus PTSD

Start date: March 2019
Phase: N/A
Study type: Interventional

This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI and PTSD.

NCT ID: NCT03818425 Recruiting - 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 Not yet recruiting - Clinical trials for Chronic Low Back Pain

Yoga and Mantram for Chronic Pain and PTSD

Start date: December 1, 2019
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.

NCT ID: NCT03812146 Not yet recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Primary Care Treatment Integrating Motivation and Exposure

PC-TIME
Start date: February 2019
Phase: N/A
Study type: Interventional

This project aims to develop and test an integrated brief intervention to reduce heavy alcohol use and PTSD severity in veterans receiving Veterans Affairs Primary Care. Standard brief alcohol interventions have been unsuccessful in reducing heavy drinking in traumatized individuals and current integrated treatment for alcohol use disorder and PTSD are too long to be delivered in Primary Care. Therefore, this application addresses this gap by developing an intervention tailored to the specific needs of heavy drinking veterans who have co- occurring PTSD. This study aims to incorporate two evidenced-based interventions: Brief Motivational Interviewing (BMI) with Prolonged Exposure for Primary Care (PE-PC). This newly developed brief intervention will be piloted in an open trial to gather veteran participant feedback and develop clinician training and fidelity procedures.