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PTSD clinical trials

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NCT ID: NCT02541630 Withdrawn - PTSD Clinical Trials

Big Mind for Veterans With PTSD

Start date: August 2015
Phase: N/A
Study type: Interventional

A variety of mindfulness-based interventions, such as Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy have been shown to be beneficial for individuals experiencing mood and anxiety symptoms. The aim of this pilot study is to test the feasibility of using a similar intervention, known as Big Mind, for veterans with PTSD and other psychological symptoms. Big Mind is a method of self-exploration that utilizes a voice dialog technique to help individuals see the world and themselves from a variety of perspectives. The investigators hypothesize that this process will increase mindfulness and decrease self-referential thinking, which is associated with negative affect. To test the feasibility of using this method, veterans with PTSD will complete a four-week group Big Mind class with a total of four sessions. The investigators will use a single group design with pre and post-intervention measures to assess tolerability and acceptance of the intervention. Secondary outcome measures will evaluate symptom improvement and increased mindfulness. If this project demonstrates that using this intervention for veterans with PTSD is feasible, then more rigorous clinical trials will be warranted.

NCT ID: NCT02398136 Withdrawn - PTSD Clinical Trials

To Test the Potential Efficacy of Repeated Intranasal Administration of Ketamine as a Treatment for PTSD

Start date: December 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to see whether ketamine, when given repeatedly via the nose (intranasally), can produce a quick and persistent improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an anesthetic for medical procedures, and at lower doses may be an effective treatment in patients with major depression and PTSD.

NCT ID: NCT01957371 Withdrawn - Chronic Pain Clinical Trials

Mindful Yoga Therapy for Veterans With PTSD and Pain

Start date: September 2013
Phase: N/A
Study type: Interventional

The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for Posttraumatic Stress Disorder (PTSD) and chronic pain among OEF/OIF/OND Veterans. The current study also seeks to establish preliminary efficacy of MYT for reduction of PTSD and chronic pain symptoms and explore anxiety sensitivity as a mechanism of therapeutic action.

NCT ID: NCT01627548 Withdrawn - PTSD Clinical Trials

UCLA Couples Counseling for Combat Veterans

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

A pilot intervention of an existing intervention adapted for the returning warfighter population: a couples treatment for PTSD, Structured Approach Therapy (SAT), which emphasizes reducing the PTSD avoidance/numbing symptoms that are corrosive in families.

NCT ID: NCT01524185 Withdrawn - Anxiety Clinical Trials

FamilyLive Feasibility and Effectiveness Study

Start date: February 2009
Phase: Early Phase 1
Study type: Interventional

Children who have been exposed to trauma (defined as physical, sexual or emotional abuse, neglect, exposure to life threatening events, domestic and community violence, parental mental health disorders, substance abuse, and/or incarceration may also have parents who have experienced trauma. Often, unresolved intergenerational trauma makes treatment of children with trauma and its sequelae, including Post Traumatic Stress Disorder, attachment disorders and dysregulation characterized by emotional lability, hyperarousal, and sleep and attention disturbances, difficult to manage. FamilyLive (FL) is a promising treatment approach developed by clinicians at the Kennedy Krieger Family Center (KKFC) over 10 years ago to address the unique needs of families with unresolved and untreated histories of neglect and disrupted attachment who need support to build skills for managing their children's responses and behaviors. FL uses a team approach with a therapist in the room with the family and call-in observations and clinical suggests from a clinician behind a one-way mirror. Through the call-in process the treatment team provides validation, acknowledgement, support and multiple perspectives for the family's experiences. The FL approach works with families to improve parental self-care, stress management, emotional regulation and self-awareness. Despite its clinical use at the KKFC, the effectiveness of the FL intervention not been systematically evaluated using a randomized design. The proposed preliminary study will use a randomized design to evaluate the feasibility of conducting a larger randomized trial of FL compared to other standard mental health care treatments (SMHC) at the KKFC. We hypothesize that it will be feasible to recruit sufficient numbers of clients for and conduct a randomized controlled trial of FL on a cohort of children exposed to neglect and trauma. We also hypothesize that FL participants will evidence greater reductions in heart rate variability, behavior problems, trauma symptoms, and improvements in functioning compared to participants in the SMHC.

NCT ID: NCT01521442 Withdrawn - PTSD Clinical Trials

Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans

Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for posttraumatic stress disorder (PTSD) among Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veterans. The current study also seeks to establish preliminary efficacy of Mindful Yoga Therapy for reduction of symptoms of PTSD and explore heart rate variability as a mechanism of therapeutic action.

NCT ID: NCT00622921 Withdrawn - PTSD Clinical Trials

Couples-based Behavioral Psychotherapy for Male Patients With Posttraumatic Stress Disorder and Alcohol Dependence

Start date: February 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Purpose: Phase I focus groups with clinicians and patients will gather qualitative data to focus and inform the content of Phase II. In Phase II, 12 weeks of psychotherapy will be offered to evaluate feasibility and potential efficacy of a couples-based, integrated treatment for men with PTSD and alcohol dependence. Hypotheses: We predict that this experimental psychotherapy, Partners Encouraging Abstinence and Coping with Emotions (PEACE), will reduce patient drinking, reduce PTSD symptoms, and improve relationship functioning.

NCT ID: NCT00375531 Withdrawn - Stress Clinical Trials

Use of Mindfulness Meditation With Iraqi/Afghanistan War Veterans

Start date: October 2006
Phase: N/A
Study type: Interventional

Objectives: The primary objective of this study is to conduct a randomized pilot study on the efficacy of Mindfulness Meditation (MfM) on sleep in post war Iraqi/Afghanistan veterans with PTSD. It is hypothesized that the change in sleep (measured by actigraphy), sleep self report measures, and PTSD symptoms (measured by the PTSD Checklist) from baseline, 8 weeks and 12 weeks will be greater for veterans with PTSD who are treated with MfM, controlling for pretreatment values and other clinical and demographic factors. A secondary objective will investigate whether there is an improvement in psychological wellness (measured by optimism, perceived wellness, and spirituality) following MfM treatments. It is hypothesized that change in optimism, perceived wellness, and spirituality from baseline, 8 weeks and 12 weeks will improve in veterans with PTSD who are treated with MfM, controlling for pretreatment values and other clinical and demographic factors. Physiological measures of actigraphy in the home will be done at baseline, eight weeks, and twelve weeks. Subjective measure of sleep include measurements of sleep and quality of life(FOSQ) and subjective sleep quality (PSQI). Other self-report measures that will examine psychological wellness include the Life Orientation Test (LOT), the Perceived Wellness Survey (PWS) and the Spirituality Assessment Scale (SAS).

NCT ID: NCT00330291 Withdrawn - PTSD Clinical Trials

Xyrem for Treatment Refractory Insomnia Due to PTSD

Start date: August 2005
Phase: Phase 2
Study type: Interventional

Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep efficiency. It is FDA approved to treat cataplexy (drop attacks) associated with narcolepsy (sleep attacks). It has been shown to be a safe and effective agent here where deep, restorative slow wave sleep improves and next day cataplexy attacks tend not to occur. Post Traumatic Stress Disorder (PTSD) is a psychiatric illness where a patient has witnessed or been involved in a traumatic event. After the event is over, nightmares, flashbacks, avoidance of people and places associated with trauma and hyperarousal occur which is incapacitating to the patient. One major part of PTSD hyperarousal is marked insomnia with multiple awakenings at night. This resultant poor sleep is compounded by use of SSRI serotonergic antianxiety agents (ie Zoloft(sertraline)) as first line therapy which tend to degrade slow wave, restorative sleep. Patients may respond to SSRI treatment but may fail to remit as they continue to have sleep problems. PTSD patients will often fail to respond to antihistamine (Desyrel (trazodone)) and benzodiazepine GABA hypnotic agents (Restoril(temazepam)) and continue with poor, interrupted sleep. It is possible that Xyrem's ability to remarkably improve slow wave sleep may greatly help treatment refractory insomnia due to PTSD. The author proposes an open-label study (no placebo) where 10 PTSD patients, who have failed usual PTSD treatments and have failed usual insomnia treatments in particular will be given Xyrem in addition to their current PTSD medication. The authors wish to determine if Xyrem is a safe treatment optionin this difficult-to-treat patient population.

NCT ID: NCT00294957 Withdrawn - PTSD Clinical Trials

Psychological and Physiological Status of Former Prisoners of War

Start date: n/a
Phase: N/A
Study type: Observational

Assessing the psychological and physiological status of Israeli former prisoners of war (POW).