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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT02242110 Recruiting - Clinical trials for Post-traumatic Stress Disorder

Brief Treatment for Trauma Nightmares in Trauma-exposed Adults With Bipolar Disorder

BERRT
Start date: June 2014
Phase: N/A
Study type: Interventional

Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. Though further evidence is needed, ERRT has shown strong support in reducing the number and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. This study will assess the efficacy in individuals diagnosed with bipolar disorder.

NCT ID: NCT02236390 Recruiting - PTSD Clinical Trials

Integrating Sleep, Nightmare and PTSD Treatments

CPTERRT
Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of the proposed pilot study is to extend previous findings regarding the efficacy of a brief treatment for chronic posttrauma nightmares and sleep problems by integrating this treatment with evidence-based treatment for posttraumatic stress disorder (PTSD). Cognitive processing therapy (CPT) (Resick & Schnicke, 1996) is a well-established and efficacious evidence-based psychological treatment for PTSD in both civilian and veteran populations (Forbes et al., 2012; Monson et al., 2006; Resick et al., 2008; Resick, Nishith, Weaver, Astin, & Feuer, 2002). The U.S. Department of Veterans Affairs (VA) includes CPT among the first-line treatments for PTSD (National Center for PTSD, 2012). A modified protocol without the utilization of written exposure (CPT-C) may be more effective than the original protocol. However, despite such promising evidence, individuals who experience chronic nightmares and sleep problems tend to show smaller gains and persistent nightmares following PTSD treatment (Nappi, Drummond, & Hall, 2012). Given that nightmares are considered the hallmark of PTSD (Ross, Ball, Sullivan, & Caroff, 1989) and their treatment-resistant nature (Davis & Wright, 2007), specific psychological treatments have been developed to target sleep disturbances and nightmares. Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. Though further evidence is needed, ERRT has exhibited strong support in reducing the frequency and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. In addition, significant decreases in PTSD and depression symptoms have been reported following treatment (Davis et al., 2011; Davis & Wright, 2007; Long et al., 2011; Swanson, Favorite, Horin, & Arnedt, 2009). ERRT is currently an evidence-level B suggested treatment (Cranston, Davis, Rhudy, & Favorite, 2011). There is a call to research suggesting the importance of treatment studies which focus on interventions that integrate nightmare and sleep symptom treatment with evidence-based treatment for PTSD (Nappi et al., 2012). In an effort to respond to this call, we propose to tailor ERRT for use in conjunction with CPT, and preliminarily test ERRT's additive effect to CPT in treating PTSD in community outpatients. We hypothesize that ERRT would increase CPT's treatment efficacy by its specific focus on trauma-related nightmares and sleep disturbances. Sleep difficulties are known to increase tension, and reduce one's ability to cope adaptively (Bonn-Miller, Babson, Vujanovic, & Feldner, 2010; Hofstetter, Lysaker, & Mayeda, 2005; Nishith, Resick, & Mueser, 2001). Thus, with improved sleep an individual may have additional personal coping resources for which s/he can use to address the broader trauma issues (Nappi et al., 2012). To test this integration, we will compare ERRT + CPT, CPT + ERRT, and CPT alone.

NCT ID: NCT02234076 Recruiting - Depression Clinical Trials

A Study on the Efficacy of Virtual Reality Exposure Therapy (VRET) for Survivors of Childhood Sexual Abuse and War Related Trauma

Start date: October 2014
Phase: N/A
Study type: Interventional

Background: Childhood Sexual Abuse (CSA) and combat related war-trauma are associated with posttraumatic stress disorder (PTSD) and depression. PTSD is one of the most prevalent Diagnostic and Statistical Manual of Mental Disorders (DSM) axis 1 disorders for which psychotherapy is widely practiced. Depression is one of the most common co morbid disorders when PTSD is diagnosed. Exposure to the traumatic memories or cues of the traumatic event often plays an important role in reducing symptoms of PTSD. Also symptoms of PTSD and depression have been related to a reduced specificity in autobiographical memory. Objective: This study will examine the efficacy of a Virtual Reality Exposure Therapy (VRET) in a CSA and war related trauma sample by comparing it with treatment as usual (TAU). It will also attempt to develop protocols to implement this new technology into clinical practice and collect data to develop a treatment progress prediction model. Study design: A randomized controlled intervention study. Study population: 144 individuals with memories of CSA or war related trauma and symptoms of PTSD and/or depression. Intervention: VRET or TAU.

NCT ID: NCT02091843 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Deep Brain Stimulation of the Amygdala for Combat Post-Traumatic Stress Disorder

Start date: January 2014
Phase: N/A
Study type: Interventional

Posttraumatic stress disorder (PTSD) affects approximately 30 % of American veterans returning from Iraq and Afghanistan. Although the current therapy is effective, a percentage of patients will fail to improve and will develop chronic treatment-resistant PTSD. Patients suffering from PTSD experience intense suffering, lack of productivity and a higher risk of suicide. Unfortunately, combat PTSD has a tendency to be resistant to current treatments. The central goal of this project is to develop a new therapeutic strategy involving the placement of intracranial electrodes to treat the symptoms of PTSD. The project is based on recent evidence showing abnormal activity in a specific brain region of PTSD patients, thought to be responsible for the core symptoms of PTSD.

NCT ID: NCT01977521 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations

tDCS
Start date: April 2014
Phase: N/A
Study type: Interventional

The present study aims to examine the efficacy of transcranial direct current stimulation on the severity of auditory hallucinations.

NCT ID: NCT01947725 Recruiting - Smoking Cessation Clinical Trials

Behavioral Activation for Smoking Cessation in Veterans With PTSD

Start date: January 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to examine whether behavioral activation as an adjuvant to standard smoking cessation treatment improves smoking cessation outcomes among veterans with PTSD relative to a comparably intense combination of standard smoking cessation treatment + health and smoking education. It is expected that behavioral activation will produce more successful results than health and smoking education when paired with standard smoking cessation treatment.

NCT ID: NCT01908647 Recruiting - Clinical trials for Traumatic Brain Injury

Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI

Start date: April 2014
Phase: N/A
Study type: Interventional

In this randomized, controlled clinical trial, we will evaluate the effects of (1) a brain-training program that uses real-time neurofeedback in functional magnetic resonance imaging (fMRI) to allow people to learn how to gain voluntary control over activity in targeted brain regions and/or (2) 8 weeks of computer-based cognitive training using a software program (Cognitive Remediation for Brain Injury (CRBI)) versus control training tasks on cognitive learning and symptoms. In addition, the investigators will measure brain function (active and resting functional magnetic resonance imaging) and structure (high resolution magnetic resonance imaging) before and after treatment.

NCT ID: NCT01754610 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Strengthening Family Coping Resources Open Trials

SFCR
Start date: February 2006
Phase:
Study type: Observational

Strengthening Families Coping Resources (SFCR) Open Trials completes the second stage of the National Institute on Drug Abuse's intervention development model by testing a new family, skills-based intervention involving pre-post evaluation of families participating in multi-family groups. The purpose of this study is to gather practice-based evidence on the effectiveness of the manualized treatment, on the dynamics involved in the group format, and on implementation fidelity and feasibility. Analyses will involve initial exploration of the following hypotheses: 1) Families will show a significant increase in the constructive use of family coping skills and in general family functioning. 2) The target child will show a reduction in trauma-related symptoms and behavior problems. 3) Parents will show significant reductions in traumatic stress and other symptoms of distress. 4) Families will engage and participate in the treatment. 5) Providers will implement SFCR with fidelity. Other outcomes of interest are the process measures that will be collected to monitor participation in the groups, cultural sensitivity and acceptability, clinician competence, and intervention integrity.

NCT ID: NCT01743664 Recruiting - Multiple Sclerosis Clinical Trials

The Efficacy of EMDR in Patients With PTSD in Multiple Sclerosis

Start date: May 2010
Phase: Phase 3
Study type: Interventional

Multiple Sclerosis (MS) can be associated to many psychological symptoms. One of the most relevant is the experience of distress related to the disease, that can lead to the development of Post Traumatic Stress Disorder (PTSD). As far as we know there are no studies on the efficacy of psychological treatments in MS in spite of its relevance for patients' quality of life. Primary aim is to evaluate the efficacy of the treatment with Eyes Movement Desensitization and Reprocessing(EMDR) in PTSD secondary to MS. EMDR is the elective treatment (together with Cognitive Behavioural Therapy) for PTSD according to international guidelines. The secondary aims are to evaluate the efficacy of EMDR on the PTSD-associated symptoms of anxiety and depression and Quality of Life. The study design is a randomized clinical trial. Sixty patients with MS and PTSD will be pre-screened by using the IES-R and the Clinician Administered PTSD Scale. The patients will be randomized in two groups (30 in the experimental group and 30 in the control group).The psychological assessment will be performed in both groups with the same timing and tools: at baseline (T0), after treatment (T1) and 6 months later (T2) by two trained clinical psychologists (independent and blind to treatment) with the CAPS and the administration of self reports: Trauma Antecedent Questionnaire, Chicago Multiscale Depression Inventory, Hospital Anxiety and Depression Scale and Functional Assessment of Multiple Sclerosis. The experimental group will undergo 10 weekly sessions of 60 minutes each with EMDR following Shapiro's protocol for traumatic events. The efficacy will be evaluated comparing the results between T0, T1 and T2 and comparing the scores of the experimental and the control groups. Primary outcome measures will be: 1) the proportion of participants at T1 and T2 no longer meeting the Diagnostic and Statistical Manual (DSM IV-TR) diagnostic criteria for PTSD; 2) the reduction of CAPS scores for the four PTSD dimensions from pre-treatment to post-treatment evaluation and follow-up (avoidance, reexperiencing the traumatic event, hyperarousal and numbing). Secondary outcome measures will be: comparison of the scores of CMDI, HADS and FAMS of the two groups at T0, T1 and T2. The statistical procedure applied will be a repeated measures analysis of covariance both on the primary outcome continuous measures and on the secondary ones.

NCT ID: NCT01730781 Recruiting - Schizophrenia Clinical Trials

Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

Start date: July 2010
Phase:
Study type: Observational

The aim of the present study is to assess the availability of cannabinoid receptors (CB1R) in the human brain. CB1R are present in everyone's brain, regardless of whether or not someone has used cannabis. The investigators will image brain cannabinoid receptors using Positron Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals and several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3) prodrome of psychotic illness and 4) individuals with a family history of alcoholism, 5) Post-Traumatic Stress Disorder 6) Opioid Use Disorder using the PET imaging agent or radiotracer, [11C]OMAR. This will allow us to characterize the number and distribution of CB1R in these conditions. It is likely that the list of conditions will be expanded after the collection of pilot data and as new data on cannabinoids receptor function and psychiatric disorders becomes available. Those in the cannabis us disorder arm of the study will have a PET scan on at least three occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4 weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most schizophrenia patients may get scanned just once, a subgroup of patients may get scanned more than once. For example to tease out the effects of medications, unmedicated patients may get scanned while unmedicated and again after treatment with antipsychotic medications. Similarly prodromes may get scanned while in the prodromal stage off medications, on medications and after conversion to schizophrenia.