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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT02761161 Completed - Depression Clinical Trials

Treatment of Sleep Disturbances in Trauma-affected Refugees

PTF5
Start date: March 2016
Phase: Phase 4
Study type: Interventional

The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD.

NCT ID: NCT02759185 Completed - Clinical trials for Posttraumatic Stress Disorder

Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD

Start date: January 2, 2017
Phase: Phase 2
Study type: Interventional

This pilot study gathered preliminary evidence of the safety and efficacy of four potencies of smoked cannabis to manage chronic, treatment-resistant PTSD among veterans: (1) High THC/ Low CBD (High THC), (2) Low THC/High CBD (High CBD), (3) High THC/ High CBD (THC/CBD) and (4) Low THC/Low CBD (placebo). The study will produce preliminary evidence to help elucidate the potential effects of THC, CBD, or a combination of both constituents to reduce PTSD symptoms. Smoked cannabis will be tested in two stages of three weeks each (Stage 1 and Stage 2), with a two-week cessation period after each stage, verified by blood/urine cannabinoid analysis. The primary objective was to compare three active concentrations of smoked cannabis and placebo on PTSD symptom severity measured by CAPS-5 total severity scores during Stage 1.

NCT ID: NCT02755103 Completed - Clinical trials for Substance-Related Disorders

Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD

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

The current study will modify an already existing therapy for individuals with substance use disorders to address Post Traumatic Stress Disorder (PTSD) in women enrolled in substance use disorders (SUD) treatment who suffer with both PTSD and SUD. Mindfulness meditation has been shown to help individuals to cope with stress and regulate emotions. Through meditation practice women will experience less distress related to PTSD symptoms and reduced substance use in response to emotional triggers. Women enrolled in intensive SUD treatment at a community program will be randomized to receive either 8 weeks of 90 minute Mindfulness Based Relapse Prevention (MBRP) group sessions plus treatment as usual (TAU) or TAU alone. The MBRP group sessions will replace 90 minutes of TAU group therapy. Measures of feasibility of implementation, acceptance and adherence will be obtained. Preliminary efficacy for substance use and PTSD symptom severity will be measured at post treatment and at 3- and 6- months' follow-up.

NCT ID: NCT02754557 Completed - Clinical trials for Post Traumatic Stress Disorder

Physiological Augmentation of Mindfulness Meditation

PAMM
Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of the study is to compare the efficacy of a physiologically-augmented breath-focused mindfulness-based intervention to reduce symptoms of dissociation that are associated with psychological trauma, as well as symptoms of posttraumatic stress disorder (PTSD). The study will evaluate whether physiological augmentation produces a greater change in dissociative symptoms, meditative engagement and attentional control, compared to non-augmented mindfulness. The augmentation comprises physiological feedback in the form of a vibration on the wrist. Vibrations are delivered by a device that will be placed on a participant's arm; the device vibrates in proportion to the person's breath.

NCT ID: NCT02749253 Completed - Clinical trials for Post Traumatic Stress Disorder

Sudarshan Kriya Yoga (SKY) in Post Traumatic Stress Disorder: a Feasibility Study

Start date: June 2016
Phase: N/A
Study type: Interventional

This pilot study is designed to investigate the feasibility of sudarshan kriya yoga (SKY) program in adults with post traumatic stress disorder (PTSD) resulting from a wide range of trauma experience. SKY incorporates standardized collection of breathing techniques which are known to positively influence the autonomic nervous system and stress response system. Both these systems are dysregulated in PTSD.

NCT ID: NCT02742532 Completed - Anxiety Disorders Clinical Trials

Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

Start date: April 20, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether oxytocin will decrease craving to use drugs/alcohol and stress reactivity following exposure to laboratory-induced stress among Active Duty Service Members with a dual diagnosis of alcohol/substance use disorder (ASUD) and post-traumatic anxiety.

NCT ID: NCT02738944 Completed - Bipolar Disorder Clinical Trials

Study to Promote Innovation in Rural Integrated Telepsychiatry

SPIRIT
Start date: November 2016
Phase: N/A
Study type: Interventional

Background: Community Health Centers care for over 20 million rural, low income and minority Americans every year. Patients often have complex mental health problems such as Posttraumatic Stress Disorder (PTSD) and Bipolar Disorder. However, Community Health Centers located in rural areas face substantial challenges to managing these patients due to lack of onsite mental health specialists, stigma and poor geographic access to specialty mental health services in the community. As a consequence, many rural primary care providers feel obligated, yet unprepared, to manage these disorders, and many patients receive inadequate treatment and continue to struggle with their symptoms. While integrated care models and telepsychiatry referral models are both promising approaches to managing patients with complex mental health problems in rural primary care settings, there have been no studies comparing which approach is more effective for which types of patients. Objectives: The central question examined by this study is whether it is better for offsite mental health specialists to support primary care providers' treatment of patients with PTSD and Bipolar Disorder through an integrated care model or to use telemedicine technology to facilitate referrals to offsite mental health specialists. We hypothesize that patients randomized to integrated care will have better outcomes than patients randomized to referral care. Methods: 1,000 primary care patients screening positive for PTSD or Bipolar Disorder will be recruited from Community Health Centers in three states (Arkansas, Michigan and Washington) and randomized to the integrated care model or the referral model. Patient Outcomes: Telephone surveys will be administered to patients at enrollment and at 6 and 12 month follow-ups. Telephone surveys will measure access to care, therapeutic alliance with providers, patient-centeredness, patient activation, satisfaction with care, appointment attendance, medication adherence, self-reported clinical symptoms, medication side-effects, health related quality of life, and progress towards life goals. A sub-sample of patients will be invited to participate in qualitative interviews to describe their treatment experience using their own words. Likewise, primary care providers will be invited to participate in qualitative interviews to voice their perspective.

NCT ID: NCT02736929 Completed - PTSD Clinical Trials

The Effect of Reducing Posttraumatic Stress Disorder Symptoms on Cardiovascular Risk

ACCEPT
Start date: April 2016
Phase: N/A
Study type: Interventional

Some individuals who are exposed to traumatic events experience both psychological and cardiovascular changes that affect their health and well-being. The purpose of this study is to learn more about how reducing the psychological symptoms (such as those that occur with posttraumatic stress disorder, or PTSD) affects cardiovascular systems that regulate heart and blood pressure.

NCT ID: NCT02736136 Completed - Depression Clinical Trials

An Early Intervention to Increase Maternal Self-efficacy After Preterm Birth

JOIN
Start date: August 2016
Phase: N/A
Study type: Interventional

This study aims to investigate the effects of an early intervention (joint observation and video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who have given birth to a very premature baby will be randomly allocated to either the early intervention or usual care whilst the infant is still hospitalized. Participants will be followed up at one month and six months. It is predicted that participants who received the early intervention will report higher maternal parenting self-efficacy than those who are not.

NCT ID: NCT02734212 Completed - Clinical trials for Post Traumatic Stress Disorder

Ending Self Stigma for PTSD

ESS-P
Start date: November 2015
Phase: N/A
Study type: Interventional

Veterans with PTSD report that stigma and fear of stigma have a chilling effect on their participation in mental health treatment. Despite the widely-documented effects of stigma on the recovery of individuals with mental illnesses and research demonstrating harmful consequences of internalized stigma, including decreased hope, self-esteem, personal motivation, and persistence regarding illness management, no interventions are currently available to assist Veterans with PTSD in combating the impact of internalized stigma. The goal of this research is to develop and pilot-test an intervention to provide Veterans with PTSD the skills to cope effectively with stigma and to mitigate the internalization of stigmatizing beliefs and stereotypes. To accomplish this purpose, Ending Self Stigma (ESS), an intervention composed of evidence-based methods for combating internalized stigma for serious mental illness, will be modified and tested to address issues particular to PTSD.