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NCT ID: NCT02131116 Completed - Schizophrenia Clinical Trials

Integrated Metacognitive Therapy in First Episode Psychosis

IMT
Start date: May 2014
Phase: N/A
Study type: Interventional

Insight, or lack of illness awareness, is a prominent and pressing clinical concern in the treatment and recovery of patients with psychotic disorders. Impaired insight results in poor treatment engagement and adherence, more frequent hospitalizations, greater positive and negative symptoms, and poor psychosocial functioning. Addressing these complications early in the disease process may lead to altered illness course with better outcomes. To date, only a small number of nonpharmacological interventions have been developed, none of which adequately address poor insight during the first few years of psychotic illness. Further, presently available therapeutic interventions do not attend to difficulties associated with improved insight, such as depression. The purpose of this investigation is to implement a novel intervention designed to improve insight, metacognition, neurocognition, symptoms, and ultimately overall functioning in persons with early psychosis. The novel intervention will integrate a number of previously established therapeutic approaches, such as metacognitive, narrative, cognitive behavioral and motivational interviewing, and hence be labeled Integrated Metacognitive Therapy (IMT). In order to measure the efficacy of IMT, all subjects will undergo a battery of assessments in each of these domains prior to and following either a novel intervention (N = 10) or treatment as usual (N = 10) for a period of approximately six months. Throughout the study, each IMT session (N = 10, 24 sessions each) will be audio recorded, transcribed, and de-identified to allow for careful ongoing qualitative analyses of potential active and inert ingredients of the approach and ultimately the development of an IMT manual which can then be tested in a larger, more rigorous randomized control trial. This investigation will play an important role in advancing current knowledge about treating insight in early psychosis. Further, it will serve to expand upon the intervention tools available by producing a much needed treatment manual designed specifically to target insight during an illness phase crucial for positive long term outcomes in psychosis.

NCT ID: NCT02129790 Completed - Bipolar Disorder Clinical Trials

Mentalization-Based Therapy to Prevent Suicidal Behavior in Adolescents With Bipolar Disorder

Start date: January 2014
Phase: N/A
Study type: Interventional

Children and adolescents with early-onset bipolar disorder (BD) are at high risk for intentionally hurting themselves. Although there are therapies in existence for these youths with BD, they do not address suicide prevention specifically. Mentalization-based therapy for adolescents (MBT-A) has been shown to be helpful in reducing self-harm in the adolescent and adult population with borderline personality disorder. The investigators will modify the MBT-A treatment procedures for persons with BD who have had a recent period of suicidal ideation or behavior.

NCT ID: NCT02128568 Withdrawn - Depressive Disorder Clinical Trials

Sub-Trial of the Youth Readiness Intervention (YRI): Treatment of Control Group and Addition of Stress Biomarkers

Start date: March 2014
Phase: N/A
Study type: Interventional

This research is a continuation of the Youth Readiness Intervention (YRI) randomized clinical trial by adding additional pre and post intervention data collection upon treatment of the control group (N=222) with the intervention which was proven effective in the larger trial. The overall research has investigated whether participation in the YRI intervention will improve emotional regulation, prosocial attitudes/behavior, social support and daily and functioning among war-affected 15-24 year olds in Sierra Leone. In this sub-study which will involve treatment of the control group with the effective YRI intervention, the investigators will add an additional measure of self-regulation as observed via DNA methylation in buccal cells collected via cheek swabs. As before, after the YRI intervention, youth will be offered a free educational opportunity at the EducAid program in Freetown or in one of its upline/provincial sites. This stage of the research, as in the treatment with the main group, will test whether youth enrolled in the YRI psychosocial intervention go on to demonstrate improved attendance and behavior in a subsidized education program. In the previous phase of the trial, the investigators did observe significant effects for the YRI intervention and evidence that the program is indeed effective. For instance, post-intervention, YRI youth reported greater improvements in emotion regulation (β=0.109, 95%CI 0.026 to 0.191, δ=0.31), prosocial attitudes/behaviors (β=0.149, 95%CI 0.057 to 0.240, δ=0.38), and social support (β=0.119, 95%CI 0.009 to 0.229, δ=0.26) than controls, and greater reductions in functional impairments (β= -0.175, 95%CI -0.299 to -0.050, δ= -0.35). Differences in symptoms were non-significant at six-month follow-up for the full sample; moderator analyses showed that, for individuals in the top quartile of baseline symptoms, YRI youth had greater improvements in emotion regulation and social support than controls. At eight-month follow-up, teachers reported that YRI participants were 8.9 times more likely to be in school (28.8% v. 4.7%) and showed better attendance (β=3.553, 95%CI 0.989 to 6.118, OR=34.93) and academic performance (β= -0.954, 95%CI -1.807 to -0.102, δ= -1.31). In this final phase of the trial as the investigators treat the wait list control group, the investigators will test whether intervention effects observed in self-report data on improved emotion-regulation are also upheld in biomarker data. Thus, the investigators will now provide YRI treatment to the wait list control group and employ the use of biomarkers as a measure of the intervention's effectiveness. The objective of the study will be to assess whether DNA methylation (collected via cheek swabs of buccal cells) is associated with changes in emotion regulation pre- and post- intervention. The aim is to test the hypothesis that the YRI is associated with improvements emotion-regulation evidence both in self-report data on emotion-regulation and in buccal cell DNA methylation. This study will add to the evidence base for effective, culturally sensitive mental health services for youth and young adults affected by war and other forms of adversity.

NCT ID: NCT02126787 Not yet recruiting - Anxiety Disorders Clinical Trials

Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment

Start date: September 2014
Phase: N/A
Study type: Interventional

Background: Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals in the treatment of anxiety disorders, and comorbid depressive or personality disorders in Poland. There is not enough evidence for its effectiveness in this environment. This study addresses this gap. The aim is to determine the effectiveness of the two kinds of day treatments consisting of intensive, short-term group therapy: psychodynamic and cognitive-behavioral for patients with anxiety disorders and comorbid depressive or personality disorders. Our objectives are: 1) Demonstrating effectiveness of each treatment in a day care setting relative to wait-list control; 2) Demonstrating the relative short- and long-term effectiveness of the two active treatments; 3) Preliminary examination of predictors and moderators of treatment response; and 4) Preliminary examination of mediators of therapeutic change; 5) Detailed comparison of impact of both methods of treatment on the outcome of used measures. Methods/design: In this randomized controlled trial, a total of 123 patients with anxiety disorders and comorbid depressive or personality disorders will be assigned to one of three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; 3) waiting list (control group). Therapy will last 12 weeks. Both treatments will be manualized (manuals will address comorbidity). Primary outcome measures are include self-report symptoms of anxiety, observer rated symptoms of anxiety, global improvement and dichotomized diagnosis of anxiety disorder. Secondary outcome measures include personality, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, mindfulness and quality of life: symptoms of anxiety, depression, personality, self-esteem and defense mechanisms. Measures are taken at baseline, post-treatment and 3 months following the end of the therapy. Discussion: The randomized controlled trial format is used to compare effectiveness of intensive group cognitive-behavior therapy and intensive group psychodynamic therapy for anxiety disorders and comorbid depressive or personality disorders. The rationale is to investigate how effectively anxiety disorders and comorbid personality disorders can be treated in a day hospital typical for Polish healthcare system in 3 months treatment.

NCT ID: NCT02125942 Completed - Clinical trials for Borderline Personality Disorder

Central Meditation and Imagery Therapy for Augmentation of Borderline Personality Disorder Treatment

Start date: April 2014
Phase: N/A
Study type: Interventional

Borderline personality disorder is a severe psychiatric disorder marked by emotional instability, difficulty with interpersonal relationships, and self-harming behaviors. Despite receiving psychotherapy for borderline personality disorder, studies show that patient recovery is slow, and there is a high rate of self injury and suicide attempts early in treatment. There is thus a clear need to provide therapies to augment psychotherapy. We will conduct a pilot trial to determine whether a 6-week Central Meditation and Imagery Therapy (CMIT) is feasible for subjects with borderline personality disorder to undergo when added on to psychotherapy treatment. CMIT is a non-validated therapy that combines principles of mindfulness with meditation techniques and guided imagery. Sessions led by a trained clinician in a group setting once a week, and participants are asked to complete daily home practice. The trial will involve 16 participants, all currently undergoing psychotherapy for borderline personality disorder. Participants will be randomly assigned to either a CMIT group that lasts 6 weeks, or a wait list group. Those in the wait list group will be able to receive CMIT after 6 weeks. All participants will continue to receive psychotherapy throughout the trial. During the trial, we will also obtain preliminary data to help understand whether CMIT may result in psychological benefits for participants. This will include measuring the pulse in order to determine variation in beat to beat intervals of the heart during psychological tests, and filling out questionnaires before and after participation in CMIT.

NCT ID: NCT02122432 Completed - Clinical trials for Dermatologic Conditions

Teledermatology Versus Usual Care on Delay Before Diagnosis and Treatment of Dermatologic Conditions

TELEDERMATO
Start date: April 2014
Phase: N/A
Study type: Interventional

In France, there is usually a long delay (approximately 6 weeks) before a general practitioner can obtain a specialized advice by dermatologists for diagnosis of "unusual" dermatologic conditions of their patients. Previous studies have shown that teledermatology is a reliable way for diagnosis in dermatology. We hypothesize that a teledermatology advice could reduce delay before diagnosis and therefore treatment for patients.

NCT ID: NCT02121431 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Child and Family Outcomes and Consumer Satisfaction for Online vs Staff-Delivered Parenting Intervention

TPAS
Start date: April 2014
Phase: N/A
Study type: Interventional

This trial addresses a serious and all-too-frequent public health problem, namely early-onset disruptive behavior problems in young children. The focus is on testing an online treatment program which empowers parents to help their children to improve their mental health and behavioral functioning. At the conclusion of the study, the investigators will know whether the online-delivered program works as well as an established staff-delivered program, with respect to child disruptive behavior problems, parenting, parent/family stress, consumer satisfaction, and value analysis.

NCT ID: NCT02120937 Completed - Bipolar Disorder Clinical Trials

Mindfulness in Mood Dysregulated Youth

Start date: March 2014
Phase: N/A
Study type: Interventional

Mindfulness group therapy can help children with mood irregularities and family history of bipolar disorder.

NCT ID: NCT02118623 Completed - Bipolar Disorder Clinical Trials

Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)

Start date: January 2014
Phase: N/A
Study type: Interventional

This study will examine if there is a benefit of an online intervention for persons with bipolar diagnoses, and what components appear to be most useful.

NCT ID: NCT02118480 Completed - Clinical trials for PARKINSON DISEASE (Disorder)

Improving Functional Disability and Cognition in Parkinson Disease: Randomized Controlled Trial

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

The study design was a parallel-group randomized trial with equal randomization. Recruitment and enrollment were conducted between June 2012 and January 2013. At base-line, clinical, cognitive and functional data was collected. Afterwards, the participants were randomly allocated to either the REHACOP group or the Control group. During 3 months the intervention with REHACOP program took place and at follow-up patients were again re-evaluated to evaluate the changes in clinical, cognitive and functional measures. Post-treatment assessment (finished by June 2013) was performed within the first week after completing the intervention.Optional enrollment in pre- post neuroimaging will also allow us to look at changes in the brain. Finally, longitudinal follow-up at 18 months with neuropsychological and neuroimaging assessements was also performed. Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to improve cognition, clinical symptoms and functional disability of patients with Parkinson disease (PD).