Pilotstudie Developmentally Adapted Cognitive Processing Therapy für Jugendliche Und Junge Erwachsene Mit Posttraumatischer Belastungsstörung Nach Sexualisierter Und /Oder körperlicher Gewalt (Pilot DCPT)
The aim of this pilot study is to evaluate the developmentally adapted cognitive processing therapy (D-CPT)in adolescents suffering from childhood abuse(CA)or physical abuse (PA) related PTSD. D-CPT's feasibility and efficacy will be examined in 20 adolescents suffering from CA or PA-related PTSD in a multicenter study (3 sites).Patients will be assessed prior to (t0), post (t1) and 6 weeks after treatment (t2). Assessments include Clinician Administered PTSD Scale (CAPS), UCLA PTSD Index (UCLA), Beck Depression Inventory (BDI), Adolescent Dissociative Experiences Scale (A-DES), and Borderline Symptom List (BSL-23).
NCT01870271 — PTSD
Status: Completed
http://inclinicaltrials.com/ptsd/NCT01870271/
7-Keto DHEA for the Treatment of PTSD
The purpose of this research study is to test the effectiveness of 7-Keto DHEA in reducing symptoms of Post-Traumatic Stress Disorder (PTSD).
NCT01861847 — PTSD
Status: Completed
http://inclinicaltrials.com/ptsd/NCT01861847/
Implementation of Evidence-based Psychotherapy for PTSD: An Empirical Investigation of Post-workshop Consultation in Treatment Fidelity and Patient Outcomes
Approximately 9% of Canadians will have Posttraumatic Stress Disorder (PTSD) in their lifetime. In the military veteran population, the lifetime prevalence of PTSD has been estimated to be as high as 20%. Numerous research studies have demonstrated that short-term, cognitive-behavioral psychotherapies, such as Cognitive Processing Therapy (CPT), lead to substantial improvements in PTSD symptoms. However, research suggests that a minority of clinicians provide these therapies in clinical settings. The transfer of this research knowledge into clinical settings remains one of the largest hurdles to improving the health of Canadians with PTSD. It is well established that attending a 2-day workshop on these therapies alone is insufficient to promote adequate knowledge transfer and sustained skillful use. The current study aims to contrast whether two forms of post-workshop support (6-month duration), with different levels of expert oversight, will result in superior levels of clinician skill and patient outcomes versus no formal post-workshop support. The three forms of post-workshop support are 1) technology-enhanced group tele-consultation 2) standard group tele-consultation 3) no tele consultation. The primary and secondary outcomes will be the assessment of the clinicians' competence in CPT and patient symptoms,respectively. This study will inform how best to transfer evidence based therapy outcomes to the clinical milieu to attain comparable outcomes as those observed in research. The investigators' hypotheses are as follows: Hypothesis 1:The technology enhanced group tele-consultation condition will evidence the highest levels of fidelity, the standard group tele-consultation condition will evidence intermediate levels of fidelity, and the no-consultation/fidelity monitoring only condition will evidence the lowest fidelity. Hypothesis 2: Fidelity to the CPT protocol, irrespective of consultation condition, will be positively associated with improved client outcomes. Hypothesis 3: Organizational context variables, such as the organizational climate and readiness for change, will influence the uptake of CPT skills, as well as the extent to which these skills are utilized in practice.
NCT01861769 — Posttraumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT01861769/
Zonisamide in Addition to Enhanced Cognitive Processing Therapy-C (E-CPT-C) for Veterans With PTSD and Comorbid Alcohol Dependence
This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization will be done using 3:1 ratio and will be performed by our research pharmacy using a random assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo. Medication will be titrated over a 6 week titration phase followed by a 6 week treatment phase. All veterans will receive E-CPT-C therapy for the 12 weeks of treatment; E-CPT-C will be provided by trained and qualified clinicians with extensive experience providing E-CPT-C. Veterans will be recruited primarily through advertisement, but also through the clinical facilities at the VA and from other collaborators.
NCT01847469 — Alcohol Dependence
Status: Completed
http://inclinicaltrials.com/alcohol-dependence/NCT01847469/
An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents
This study plans to develop an integrated treatment for comorbid post-traumatic stress disorder (PTSD) and substance abuse (SA) in adolescents. The investigators aim to develop a treatment approach that is community-friendly, well-tolerated, and deliverable by substance abuse counselors (SAC) in outpatient settings. The proposed Trauma-Focused Substance Abuse Treatment (TFSAT) aims to reduce PTSD symptoms and substance use and build coping skills. The investigators propose to adapt an evidence-based trauma program, Cognitive-Behavioral Intervention for Trauma in Schools (CBITS), for adolescent substance abusers (ASAbusers); to assess the acceptability and feasibility of the integrated approach; and to pilot test the new program against standard care. The investigators hypothesize that the intervention group, compared to the control group, will reduce substance use and symptoms for traumatic stress.
NCT01825694 — Substance Abuse
Status: Completed
http://inclinicaltrials.com/substance-abuse/NCT01825694/
CRF Receptor Antagonist for PTSD and Related Sleep Disturbances in Women
This purpose of this study is to look at the safety of the experimental drug GSK561679 as well as its effects on PTSD symptoms, thinking and memory, startle reaction, stress hormones, and mental health symptoms in comparison to placebo (an inactive substance).
NCT01814332 — Stress Disorders, Post-traumatic
Status: Completed
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT01814332/
Biomarkers of Clinical Response to Cognitive Treatment of PTSD in Youth
This study will examine how brain activation changes as a result of behavioral treatment for posttraumatic stress disorder (PTSD) in adolescents. The investigators will conduct functional magnetic resonance imaging (fMRI) scans before and after the widely-used trauma-focused cognitive behavioral therapy to better understand how the brain recovers from illness. This study will provide much needed information about brain abnormalities in abused youth, and could lead to improvements in behavioral treatments for patients who do not respond to current treatments.
NCT01806701 — Emotions
Status: Completed
http://inclinicaltrials.com/emotions/NCT01806701/
The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian Post-Traumatic Stress Disorder
The purpose of this study is to assess the effects of repetitive transcranial magnetic stimulation (rTMS) in civilian patients with a confirmed diagnosis of post-traumatic stress disorder (PTSD). This research study will determine whether low-frequency (1 Hertz [Hz]) or high-frequency (10 Hz) rTMS over the right dorsolateral prefrontal cortex (DLPFC) has an effect on symptoms of PTSD compared to sham rTMS treatment.
NCT01806168 — Post-traumatic Stress Disorder (PTSD)
Status: Completed
http://inclinicaltrials.com/post-traumatic-stress-disorder-ptsd/NCT01806168/
Hair Cortisol Level as a Predictor of PTSD Development
Post-traumatic stress disorder, PTSD, is one of the most prevalent psychiatric disorders. As casualties of motor vehicle accidents, criminal acts or terrorism are arriving to the ER, it is almost impossible to conclude who will overcome his psychiatric trauma and will be able to return to his normal life course and who will be thrown out of his promising life trajectory. Current attempts to identify those who are at the greatest risk are still unsatisfactory, which comprise a therapeutic dilemma, since the interventions used to ameliorate and prevent the occurrence of PTSD in a high-risk patient, might be counter-productive and even precipitate the emergence of PTSD in lower-risk patients. Since PTSD is closely related to the "Fight, Flight or Freeze" reaction, it has much to do with the autonomic nervous system and the major stress hormone, cortisol. Despite many studies demonstrating the involvement of those factors in the development of PTSD, various attempts to profile the direction of the association between PTSD and cortisol abnormalities have yielded conflicting results. The introduction of a novel method of assessing the excretion of cortisol using residues in the human hair shaft, has allowed an unprecedented evaluation of its activity over a prolonged period of time. Using this novel method of cortisol assessment, the investigators aim to identify biomarkers that will be able to aid in the prediction of PTSD development ahead of symptoms emergence, and will enhance the understanding of the physiological mechanism involved and etiology of this disorder.
NCT01804426 — Post Traumatic Stress Disorder
Status: Withdrawn
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT01804426/
Posttraumatic stress disorder (PTSD) is a common and debilitating neuropsychiatric disorder in which an acute fear response to a traumatic event does not abate. This failure to recover from trauma is thought to be due at least in part to a deficit in learning not to fear situations and stimuli previously associated with the trauma (i.e., specifically due to a failure of extinction recall). Pavlovian fear conditioning can be simulated and measured experimentally in humans using a 2-day fear conditioning paradigm developed by our group, wherein conditioning and extinction learning phases are conducted on Day 1, and extinction recall is tested on Day 2. Recent functional magnetic resonance imaging (fMRI) evidence indicates that PTSD is associated with hyper-responsivity of the insular cortex and hyporesponsivity of the ventromedial prefrontal cortex (VMPFC) during exposure to fear-inducing stimuli, consistent with altered excitability of brain regions mediating fear conditioning and extinction. As the brain's principal inhibitory neurotransmitter, GABA exerts a prominent role in modulating neuronal excitability. Interestingly, there are reports that adjunctive treatment with GABA-enhancing antiepileptics is efficacious in PTSD. There is also evidence, albeit inconsistent, that lower serum GABA levels predict a more chronic course of the illness. However, it is unclear whether serum levels accurately reflect brain GABA, which may contribute to inconsistency of serum findings. Moreover, it is possible that GABA alterations may vary in their presence, nature and significance across brain regions implicated in PTSD. The proposed study will examine the relationship of PTSD symptoms and behavioral fear conditioning deficits with regional brain gamma-aminobutyric acid (GABA) using proton magnetic resonance spectroscopy (1H-MRS). We have the following aims and hypotheses: 1. To determine whether GABA alterations are associated with the categorical diagnosis of PTSD and not merely exposure to trauma. It is hypothesized that PTSD will be associated with higher GABA in VMPFC and lower GABA in the right insula. 2. To determine whether GABA levels are significantly associated with dimensional measures of PTSD symptom severity and individual symptom dimensions. It is predicted that higher GABA in the VMPFC and lower GABA in the right anterior insula will be associated with greater total symptom severity. 3. To determine whether GABA in VMPFC and right anterior insula are significantly associated with measures of extinction recall failure and anxiety sensitivity in PTSD. It is hypothesized that VMPFC GABA will be positively correlated with skin conductance response to a conditioned stimulus that had previously been extinguished and insula GABA will be negatively correlated with anxiety sensitivity.
NCT01800383 — Stress Disorders, Post-Traumatic
Status: Completed
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT01800383/