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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT01443182 Completed - Clinical trials for Posttraumatic Stress Disorder (PTSD)

Treatment of Posttraumatic Stress Disorder (PTSD) in Adult Survivors of Early Chronic Interpersonal Trauma

Start date: September 2011
Phase: N/A
Study type: Interventional

Eye movement desensitization and reprocessing (EMDR) and trauma-focused cognitive-behavioural therapy (TF-CBT) have both been found to be effective in treating post-traumatic stress disorder (PTSD) following single-event traumas and to be more effective than pure anxiety management or stabilization treatments. However, much less is known about the efficacy of the different treatment approaches in survivors of repeated or chronic interpersonal trauma. Recent evidence suggests that a combination of stabilization treatment + TF-CBT is efficacious in this population. Although EMDR is also often used in survivors of chronic interpersonal trauma, evidence on its efficacy are still poor. The aim of the current study is to compare the efficacy of (1) stabilization + TF-CBT and (2) stabilization + EMDR using a randomized controlled trial in a routine clinical setting.

NCT ID: NCT01437891 Completed - Clinical trials for Post-traumatic Stress Disorder

Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)

GWF001
Start date: September 2011
Phase: N/A
Study type: Observational

An open-label clinical outcomes study to determine the safety and efficacy of Sentra AM® and Sentra PM® for post-traumatic stress disorder (PTSD) and Gulf War fibromyalgia (GWF).

NCT ID: NCT01430832 Terminated - Clinical trials for Post Traumatic Stress Disorder

Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum

Start date: September 1, 2011
Phase:
Study type: Observational

The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration. In addition, the correlation between the infant's development and the mother's emotional state will be analyzed.

NCT ID: NCT01430624 Completed - Clinical trials for Posttraumatic Stress Disorder

Prevention of Post Sexual Assault Stress

Start date: May 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether a brief intervention in video format, that includes education about reactions to assault and modeling of adaptive coping strategies, designed to reduce post assault drug use or abuse and PTSD and shown to recent victims of sexual assault at the time of receipt of post assault medical care is associated with better post-assault outcomes as compared to a comparable length video that includes pleasant imagery and relaxation instruction or standard care.

NCT ID: NCT01419223 Completed - Clinical trials for Post-Traumatic Stress Disorder

Patient Participation Beliefs and Post-Traumatic Stress Disorder (PTSD)

Start date: July 2011
Phase: N/A
Study type: Observational

This is an exploratory qualitative interview study being conducted with a primary objective of examining perceptions held by active military and veterans regarding help-seeking attitudes and mental health beliefs which influence the decision to consent or decline participation in Post-Traumatic Stress Disorder (PTSD) or Traumatic Brain Injury (TBI) clinical trials. Active duty military and/or veterans aged 18 years and older who consent to participate (N = 50), or have recently declined participation (N = 50), in an INTRuST affiliated outpatient clinical trial for deployment-related PTSD or TBI will be recruited. Participants who consent to participate in an INTRuST clinical trial (Group 1) will be interviewed once at the beginning the of the clinical trial, and again following participation in the trial. Participants who decline participation in an INTRuST affiliated outpatient clinical trial (Group 2) will be interviewed once. For participants in both groups, study participation will initiate within 1 month of referral to study. Total duration of study participation is based on the specific clinical trial that the participant is recruitment from; the longest trial is estimated to be 24 weeks or less. Semi-structured qualitative individual interviews will be conducted to carry out a thematic analysis of the data exploring familial, social and institution-level constructs which may influence the subjective experience of the research treatment process.

NCT ID: NCT01416948 Terminated - Clinical trials for Traumatic Brain Injury

Cognitive REmediation After Trauma Exposure Trial = CREATE Trial

CREATE
Start date: August 2011
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy of methylphenidate and galantamine in the treatment of persistent cognitive symptoms associated with posttraumatic stress disorder (PTSD) and/or traumatic brain injury (TBI).

NCT ID: NCT01413984 Completed - Trauma Clinical Trials

Substance Abuse and Trauma in Incarcerated Women

Start date: November 2010
Phase: N/A
Study type: Interventional

The proposed study will evaluate Covington's Helping Women Recover (HWR) plus Beyond Trauma (BT) curriculum with female offenders at Eddie Warrior Correctional Facility in Taft, Oklahoma. The purpose of the proposed study is to expand previous findings by including a comparison group of women that are not receiving treatment but are otherwise eligible, and by using outside evaluators to conduct the assessments. Furthermore, this study will extend the outcomes measured in previous evaluations by including measures of sleep disturbance, posttraumatic cognitions, and a more extensive assessment of trauma-related symptoms. The hypotheses for this study are listed below: 1. Incarcerated women with substance use disorders and history of trauma enrolled in the integrated treatment program (HWR plus BT) will report significantly fewer symptoms on measures of posttraumatic stress and associated cognitions, substance use, depression, and related symptoms following treatment than those in the comparison group. 2. Those in the treatment group will improve significantly more than those in the comparison group on the symptoms listed above.

NCT ID: NCT01410721 Completed - Clinical trials for Traumatic Brain Injury

Neural Markers and Rehabilitation of Executive Functioning in Veterans With Traumatic Brain Injury and Posttraumatic Stress Disorder

Start date: January 2012
Phase: N/A
Study type: Interventional

Up to half of all military service members with combat-related traumatic brain injury (TBI) also suffer from Posttraumatic Stress Disorder (PTSD). TBI and PTSD are each associated with cognitive problems in what are called 'executive functions' such as planning actions, inhibiting behavior, monitoring one's own thoughts and feelings, and solving problems day-to-day. These types of impairments occur more often among veterans with both TBI and PTSD than among those with only one of these conditions. The combination of TBI and PTSD in veterans has also been linked to problems with anger and violence, which are common complaints of veterans seeking mental health services post-deployment and have been shown to predict poor treatment outcomes in Iraq and Afghanistan veterans. Although the relationship between combined TBI/PTSD diagnoses and post-deployment adjustment problems has been demonstrated, there has been little research into clinical interventions designed to reduce the severity of cognitive and affective symptoms in veterans with both TBI and PTSD. Therefore, the investigators propose a randomized clinical trial involving a cognitive rehabilitation intervention that targets improved executive functioning, with the participation of N=100 veterans diagnosed with both TBI and PTSD (n=50 in experimental group and n=50 comparison). As part of the study, all participants will receive an iPod touch. Participants will be placed into one of the two study groups randomly. Based on which group participants are placed in, they will receive one of two different sets of iPod touch apps and programs that address and aim to improve different facets of cognitive functioning. Regardless of which group, Veterans will be instructed to daily practice iPod touch applications on cognitive functioning. Also, family members will be trained as "mentors" to reinforce use of the applications in everyday living environments. Trained facilitators will also travel to participants' homes to meet with veterans and family to observe behaviors in the home environment, arrive at strategies for applying new skills in their situations, troubleshoot any iPod technical problems, and review family mentoring processes. The investigators will measure clinical outcomes using a comprehensive array of functional and structural methods at baseline and six months. The investigators hypothesize improved executive function among those in the experimental group as well as reduced irritability/impulsivity and improved social/occupational functioning. The investigators further hypothesize that, as a group, veterans participating in the cognitive rehabilitation program will show significant changes in neural activity associated with executive functions when comparing pre- and post-treatment EEG and fMRI responses. Better understanding of the neural circuitry and neurocognitive function underlying executive function and associated affective control deficits in veterans with both TBI and PTSD, and how they relate to treatment outcome, will allow us to better identify therapeutic targets for cognitive rehabilitation. The current proposal aims to explore the relationship between brain function and connectivity in selective pathways/circuits, neuropsychological functioning, and cognitive rehabilitation response in veterans with both TBI and PTSD. This study of the neurobiology and neuropsychology associated with intervention efficacy will allow us to identify veterans with both TBI and PTSD who are predisposed to positive treatment outcomes. To our knowledge, this will be the first attempt to integrate neurobiological and neurocognitive techniques with information about the efficacy of a theoretically and empirically driven cognitive rehabilitation intervention in veterans with combined TBI/PTSD diagnoses. This research may suggest additional avenues for assessment of clinical intervention efficacy and the identification of therapeutic targets (e.g. alteration of function in fronto-limbic circuits) relevant to the military population. Given links between TBI/PTSD, executive dysfunction, and anger, impulsivity, and aggression, efforts to rehabilitate cognitive function will be particularly important to ensure that current and future veterans adjust successfully when they return home to their families, workplaces, and communities.

NCT ID: NCT01409707 Completed - Clinical trials for Posttraumatic Stress Disorder

Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder

Start date: July 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to test if provision of an effective psychotherapy for Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol dependent patients with PTSD and if it is associated with better treatment outcomes compared to an active control condition.

NCT ID: NCT01408641 Terminated - Clinical trials for Alcohol Use Disorder

Topiramate for Alcohol Use in Posttraumatic Stress Disorder

Start date: September 2012
Phase: N/A
Study type: Interventional

Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more difficult than treating AUDs in the general population. The FDA-approved medication topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has also improved symptoms in people with PTSD. This study is designed to investigate whether topiramate will improve drinking outcomes in Veterans with PTSD.