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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT02911285 Completed - Clinical trials for Alcohol Use Disorder (AUD)

NAC for Treating Comorbid PTSD and SUD

DoD-NAC
Start date: October 2016
Phase: Phase 2
Study type: Interventional

As a result of sustained operations in Afghanistan and Iraq, there are an increasing number of U.S. military Veterans with substance use disorders and comorbid posttraumatic stress disorder (PTSD). If left untreated, individuals with substance use disorders and PTSD are at increased risk for developing other mental health problems (e.g., depression, anxiety), suicidal ideation and attempts, medical problems, reduced resiliency and military readiness, vocational problems, and family/social impairment. This study will determine the benefits of N-acetylcysteine (NAC) in treating alcohol use disorder and comorbid post-traumatic stress disorder (PTSD) among military Veterans.

NCT ID: NCT02900053 Completed - Clinical trials for Post-traumatic Stress Disorder

Post-traumatic Stress Disorder Treatment Using Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy : a Two-arm Randomized Controlled Multicentric Study.

T-TREAt
Start date: January 2017
Phase: N/A
Study type: Interventional

Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that can develop after exposure to a terrifying event or ordeal in which there was the potential for or actual occurrence of grave physical harm. Traumatic events that may trigger PTSD include violent personal assaults, natural or human-caused disasters, accidents, and military combat. People with PTSD have persistent frightening thoughts and memories of their ordeal, may experience sleep problems, feel detached or numb, or be easily startled. Its lifetime prevalence is quite high, with 7-8% in various studies and 4% in french studies. The current PTSD treatment usually involves antidepressants as serotonin-specific reuptake inhibitors (SSRIs) and Cognitive Behavioral Therapies, such as exposure therapy to trauma-linked elements (memories, feelings and thoughts) so the fear associated to the traumatic event can decrease. But the therapeutic response stays partial, even combining these treatments. To improve the PTSD treatment efficiency, innovative approaches are being explored like new drugs or cerebral stimulation. This project aims to assess the efficacy of a less known but promising therapeutic strategy for PTSD : the use of transcranial Direct-Current Stimulation (tDCS) to enhance the trauma-focused therapy results.

NCT ID: NCT02898883 Completed - Clinical trials for Posttraumatic Stress Disorder

Building Resilience After Childhood Emergencies (BRACE)

BRACE
Start date: October 2015
Phase: N/A
Study type: Interventional

The investigators study seeks to evaluate the feasibility and efficacy of a parent-focused, early intervention to prevent the development of chronic PTSD for children admitted to the emergency department for an acute traumatic injury and their parents. Furthermore, the investigators will identify potential risk factors for the development of PTSD and factors that influence treatment response. Finally, the investigators will prospectively measure trajectories of parental and child responses to trauma and their interaction over time. This study will bring together a multidisciplinary team across two major research universities (Case Western Reserve University and Kent State University) and a large pediatric trauma center (Akron Children's Hospital) in an effort to reduce rates of PTSD in children following traumatic injury.

NCT ID: NCT02893202 Completed - Clinical trials for Posttraumatic Stress Disorder

Equine Assisted Activities on PTSD, Quality of Life and Functioning in Veterans With PTSD: An ICF Approach (THRICF)

THRICF
Start date: August 2013
Phase: N/A
Study type: Interventional

The purpose of the research project was to assess changes in Posttraumatic stress disorder [PTSD] symptoms, quality of life and participation of combat veteran who participate in equine assisted activities [EAA]. The study used a mixed-methods, waitlist-controlled, repeated measures trial of a standardized 8-week therapeutic riding intervention for combat veterans with PTSD. Behavioral changes were assessed four times during the study. Veterans meeting inclusion criteria were selected to participate in either the intervention group or the control/waitlist group.

NCT ID: NCT02891421 Completed - Clinical trials for Traumatic Brain Injury

Therapeutic Horsemanship in Veterans

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

The project partnered with U.S. military veterans with a premier accredited therapeutic riding center for six weeks. The veterans interacted with horses by grooming and learning about them, as well as riding them for one hour per week during which they gained a variety of skills. We hoped the veterans would experience a reduction in Post Traumatic Stress Disorder (PTSD) symptoms, depression, and loneliness, while improving their social and emotional health and self-efficacy.

NCT ID: NCT02887027 Completed - Depression Clinical Trials

Exercise, Mood and Stress Study

Start date: February 2016
Phase: Phase 1
Study type: Interventional

Multiple studies indicate that exercise is effective in treating depressed mood and reducing anxiety sensitivity. As depressive symptoms and anxiety sensitivity are elevated in individuals with anxiety and depressive disorders, exercise could help reduce these symptoms and aid in the overall treatment of these disorders. This project aims to test an ecological momentary exercise intervention (Exercise4Mood) delivered via a mobile phone application in individuals with anxiety or depressive disorders. Previous protocols have tested the acceptability and usability of Exercise4Mood in healthy participants. In Phase 1 of the study, focus groups were conducted to explore the acceptability and usability of the Exercise4Mood app. Qualitative feedback was collected and modifications were made to the app based on this feedback. In Phase 2 of the study, the Exercise4Mood app was tested in 6 healthy participants. Preliminary unpublished findings indicate that the app was acceptable and promoted increased physical activity. The aim of this protocol is to test the acceptability, usability, and efficacy (to improve mood and reduce anxiety) of Exercise4Mood in patients with anxiety or depressive disorders.

NCT ID: NCT02876172 Completed - Clinical trials for Posttraumatic Stress Disorder

MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD

Start date: July 3, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2 open-label study will combine methods for conducting MDMA-assisted therapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners (intimate or non-intimate significant other who does not have a current diagnosis of PTSD) in order to explore whether combined treatment is effective. Each therapy team will have one therapist trained and experienced in MDMA assisted psychotherapy and one therapist trained and experienced in CBCT. During the first experimental session, both participants will receive 75 mg of MDMA followed 1.5 to 2 hours later by an optional supplemental half-dose of 37.5 mg. During the second experimental session, an initial dose of either 100 or 75 mg of MDMA will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 37.5 mg. The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in CAPS-5 total severity scores in PTSD participants.

NCT ID: NCT02875912 Completed - Depression Clinical Trials

Prospective Evaluation of Family Care Rituals in the ICU

FCR
Start date: September 2015
Phase: N/A
Study type: Interventional

This study will evaluate whether or not engaging family members of patients admitted to the ICU in "Family Care Rituals" will reduce stress related symptoms of PTSD, depression and anxiety 90 days after patient death or discharge from the ICU. Family Care Rituals are defined as several domains in which family participation may be of benefit, focusing on the 5 physical senses as well as the personal care of the patient and spirituality of the patient

NCT ID: NCT02874898 Completed - Marijuana Abuse Clinical Trials

Short-Term Exposure for PTSD

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

This study examines how marijuana use affects processes related to recovery from chronic posttraumatic stress disorder (PTSD). Half the participants will be individuals with chronic PTSD and heavy marijuana use and half will be individuals with chronic PTSD and no marijuana use. This study will assess how individuals with PTSD with heavy or no marijuana use perform on a discriminative conditioning and extinction paradigm designed to measure fear extinction learning, and how they respond to a brief daily imaginal exposure treatment in regards to PTSD symptom reduction.

NCT ID: NCT02874235 Completed - Clinical trials for Stress Disorders, Post-Traumatic

Music Therapy and Treatment as Usual

RCT-KTF
Start date: May 9, 2016
Phase: N/A
Study type: Interventional

This study compares music therapy with verbal psychotherapy (treatment as usual) in an outpatient psychiatric clinic for traumatized refugees. Based on positive results from a pilot study, the randomized clinical trial has a non-inferiority design to detect whether music therapy is not less effective than verbal therapy carried out by psychologists and can serve as a complementary treatment modality (n=70). The participants are adult Arabic, English or Danish speaking refugees suffering from posttraumatic stress disorder (PTSD). The patients are referred to outpatient treatment by their medical doctor. Data collection takes place in three locations of the clinic in Region Zealand, Denmark. The music therapy method used is Guided Imagery and Music (GIM). Primary outcome is pre, post and 6 months follow-up measures of HTQ (Harvard Trauma Questionaire) and two measures of PTSD-8 during treatment. Secondary outcomes are pre, post and 6 months follow-up measures of Quality of Life Questionnaire (WHO-5), Dissociation Symptom Scale (DSS), Somatoform Dissociation Questionaire (SDQ-20), Revised Adult Attachment Scale (RAAS) and physiological measures (salivary oxytocin, betaendorphin and Substance P).