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NCT ID: NCT01696617 Completed - Clinical trials for Major Depressive Disorder

Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder

Start date: February 10, 2012
Phase: Phase 4
Study type: Interventional

The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of standard antidepressants would be associated with improved depression response in Major depressive disorder, especially in Quality of life. The investigators compare the mean changes in the quality of life between before add-on and 8 weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of aripiprazole.

NCT ID: NCT01693978 Completed - Clinical trials for Posttraumatic Stress Disorder

Contingency Outcomes in Prolonged Exposure

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

The aim of this research is to assess whether Contingency Management is effective in improving treatment adherence in substance use disordered (SUD) patients with comorbid PTSD. Although Prolonged Exposure therapy (PE) is the gold standard treatment for PTSD, the few studies of this treatment in substance users have shown poor adherence. Contingency Management is a well-established approach that could be used to enhance adherence to PE. From a consented sample of 125 opioid-dependent and methadone-treated patients at Addiction Treatment Services, an intent-to-treat sample of 62 patients with co-occurring current PTSD will be offered PE. Half of the 62 participants will be randomly assigned to a Prolonged Exposure with Contingency Management (PE+CM) condition that provides monetary-based incentives for attending the PE therapy sessions. The comparison condition will be assigned to a Prolonged Exposure (PE) condition without the attendance incentives intervention. The PE sessions will be scheduled once per week for 12 weeks, with a 12-week follow-up. Groups will be compared primarily on adherence to the PE schedule, improvement in PTSD symptoms, and rates of drug use (urine specimens, self-reported use). The study's three primary aims are to 1) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to increase adherence in SUD patients in a methadone treatment program; 2) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to reduce PTSD symptoms in SUD patients; and 3) Evaluate the effect of PE for PTSD on rates of drug use in SUD patients.

NCT ID: NCT01692574 Completed - Obesity Clinical Trials

Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)

TODI
Start date: August 2012
Phase: N/A
Study type: Interventional

To determine whether individuals who suffer from depression and obesity are able to lose weight and show improvements in mood and cardiovascular disease risk factors following 20 weeks of a combined treatment of cognitive-behavior therapy for depression and behavior modification for weight loss. Participants will be assigned to one of three treatments: 1) cognitive-behavior therapy for the treatment of depression combined with an alternative approach to weight loss, 2) a weight loss intervention combined with a depression support and education , or 3) cognitive-behavioral therapy for depression combined with a weight loss intervention.

NCT ID: NCT01691092 Completed - Clinical trials for Major Depressive Disorder

PET Imaging of mGLuR5 With Drug Challenge

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

This study is designed to look at that involvement of a process in the brain called the glutamate system in depression. Participants will undergo a screening session, up to two fMRI scans, and up to three PET scans, as well as cognitive testing at each scan session. For one of the PET scans, a drug (either ketamine or n-acetyl cysteine) will be administered. Hypothesis 1: The investigators hypothesize administration of ketamine or n-acetylcysteine (NAC) will lead to a decrease in mGluR5. Hypothesis 2: The investigators hypothesize an improvement in memory and attentional skills after drug challenge. Hypothesis 3: The investigators hypothesize an increase in mGluR5 availability and change in MRI measures post drug challenge as compared to baseline, signifying synaptogenesis. Hypothesis 4: We expect there should not be a significant difference in reduction in mGluR5 availability due to differences in ABP688 radiotracer infusion.

NCT ID: NCT01690013 Completed - Quality of Life Clinical Trials

Life Quality and Health in Patients With Klinefelter Syndrome

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

Klinefelter syndrome is the most common sex-chromosome disorder in men with a prevalence of 1 in 660 men. The syndrome is associated with hypogonadism. Many patients with Klinefelter syndrome have psychological complaints and physical discomfort. Some patients report a positive effect of testosterone treatment, whereas others do not. The aim of this study is: (i) To investigate quality of life in patients with Klinefelter syndrome. (ii) To investigate functional, physical and mental health in patients with Klinefelter syndrome. Questionnaire concerning mental and physical health and life quality are sent out to patients with KS and to age-, educational- and zipcode-matched men from the general population. The questionnaire include questions about housing, income, marital status, fatherhood, medication, chronic disease,school and education, attachment to the labor, sexual and erectile function, life quality, mental and physical health, satisfaction with life and symptoms of attention deficits hyperactivity disorders.

NCT ID: NCT01686438 Completed - Clinical trials for Sleep Initiation and Maintenance Disorders

Telemedicine Management of Chronic Insomnia

VIP
Start date: April 1, 2013
Phase: N/A
Study type: Interventional

Insomnia is commonly present in Veterans with post-traumatic stress disorder (PTSD). Treatment of insomnia with a specialized type of psychotherapy has been shown to be more effective than treatment with medications. Unfortunately, few psychologists are trained to provide this treatment, limiting Veterans' access to care, especially those Veterans in remote and rural areas. This project will evaluate the ability to deliver this psychotherapy to groups of Veterans by video teleconferencing. Groups of Veterans with PTSD and chronic insomnia will receive the psychotherapy treatment either by meeting in-person with the psychologist or by the psychologist delivering the treatment by video teleconferencing. Finding that video teleconferencing is a cost effective way to deliver this treatment could add an important new component to the care of Veterans with PTSD that provides an alternative to medications.

NCT ID: NCT01684488 Completed - Clinical trials for Stress, Psychological

Trial of the Youth Readiness Intervention

YRI
Start date: April 2012
Phase: N/A
Study type: Interventional

The research will first examine data obtained from YRI participants to investigate effects of the group sessions on psychosocial and functioning outcomes in youth. In pursuit of this aim, this research will investigate the following hypothesis: Participation in the Youth Readiness Intervention will reduce symptoms of internalizing, externalizing, trauma-related symptoms, and improve prosocial skills and functioning among war-affected 15-24 year olds in Sierra Leone. The research also intends to examine whether youth enrolled in a psychosocial "Youth Readiness Intervention" (YRI) and a complementary education program fare better than an education-only control group, a psychosocial-only control group, and a waitlist control group. In pursuit of this second aim, this research will investigate the following hypothesis: A combined psychosocial-education program is an effective paradigm for improving psychosocial, functional, educational, and economic self-sufficiency outcomes among war-affected youth.

NCT ID: NCT01683539 Completed - Schizophrenia Clinical Trials

Understanding How Cognitive Remediation Works

Cog-2
Start date: September 2012
Phase: N/A
Study type: Interventional

This study is aimed at evaluating whether the computer-based cognitive exercises in the Thinking Skills for Work (TSW) program are critical to improving work and cognitive outcomes in consumers with serious mental illness and cognitive impairment enrolled in supported employment (SE), or whether a streamlined version of TSW without this component (the Cognitive Skills for Work (CSW) program) is equally effective for some or all consumers. An RCT will be conducted at two sites (Mental Health Center of Greater Manchester in New Hampshire and Thresholds Inc. in Illinois) with 244 consumers randomly assigned to one of two groups (122 each, with approximately 122 participants having schizophrenia or schizoaffective disorder and 122 of the participants having other diagnoses): 1) TSW, or 2) CSW. The TSW and CSW programs will be delivered by the same Cognitive Specialists, who will work as members of the SE team to integrate cognitive and vocational services. All participants will continue to receive SE services. Participants will be assessed at baseline, post-treatment at 8 months (after completion of the active teaching components of TSW or CSW), and at 16 and 24 months post-baseline to evaluate cognitive functioning, symptoms, and quality of life. All work outcomes will be tracked weekly. In addition, a supplementary study, commencing in September 2015, will assess a promising biomarker for understanding the mechanisms underlying the effects of cognitive remediation, brain-derived neurotrophic factor (BDNF), in new enrollees in the parent R01 study. This supplement will complement the aims of the parent R01 by shedding light on possible mechanisms related to how TSW works and for whom, thereby informing efforts to refine and improve the program, as well as targeting individuals who fail to benefit. The supplement will take place at the same sites as the parent R01.

NCT ID: NCT01681329 Completed - Clinical trials for Generalized Anxiety Disorder

Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder

CBT+IMT-GAD
Start date: September 2012
Phase: N/A
Study type: Interventional

Generalized Anxiety Disorder (GAD) is a condition characterized by chronic and excessive worry and anxiety. Our group has developed a cognitive-behavioural treatment (CBT) for GAD that has been tested in four previous clinical trials. The findings show that 60 to 70% of affected individuals attain GAD remission and that 50 to 55% achieve high endstate functioning following the treatment. Although these numbers are encouraging, there remain a considerable proportion of individuals who do not fully benefit from treatment. In our most recent CIHR-funded treatment study, we assessed the impact of information processing on the efficacy of CBT for GAD. Our findings show: a) that the tendency to negatively interpret ambiguous information at pre-treatment was associated with greater GAD symptoms at post-treatment; and b) that patients who were less successful at changing their negative interpretation style were also less responsive to CBT. Given that computerized interpretation modification training has been shown to be effective for decreasing the negative interpretation style of anxious individuals, the goal of the current proposal is to determine whether such training can augment the efficacy of CBT for adults with GAD. A total of 138 individuals with a primary diagnosis of GAD will be randomly allocated to one of two conditions: a) CBT plus interpretation modification training or b) CBT plus non-active training. CBT will consist of 14 weekly sessions, with interpretation modification training (or non-active training) administered prior to each session. Measures of GAD symptoms, psychopathology, cognitive vulnerability, and interpretation style will be administered at pre-, mid-, and post-treatment, as well as at 6- and 12-month follow-ups. The proposed study will provide information about the efficacy, clinical usefulness, and mechanisms of interpretation modification training in combination with CBT.

NCT ID: NCT01681173 Completed - Obesity Clinical Trials

OPTIFIT-Optimal Fiber Trial for Diabetes Prevention

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

High intake of insoluble fiber is strongly associated with a reduced incidence of diabetes and cardiovascular events in prospective observation studies. Our primary objective is to compare a life style diabetes prevention program(PRAEDIAS) with and without added insoluble fibers in its effectiveness to prevent incident diabetes type 2 in high risk individuals with impaired glucose tolerance. Subjects with IGT not willing to participate in the intervention will be used as independent controls. Secondary aims are to identify mechanisms of action with regard to body composition, anti-inflammatory and metabolic effects of fibers. We propose a randomized, prospective intervention study. The results will be of general relevance for guidance of fiber intake in the population and will help the food industry to design healthy high fiber foods. Fiber can be added at low cost to numerous foods. Increased fiber intake may therefore provide a simple non-cognitive prevention strategy effective at the population level.