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Hallucinations clinical trials

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NCT ID: NCT04127526 Completed - Psychosis Clinical Trials

Psychological Therapy for Dissociation, Trauma and Voices: A Single Case Experimental Design

CONNECT
Start date: September 11, 2019
Phase: N/A
Study type: Interventional

Connection to Environment with Cognitive Therapy (CONNECT): A Single-Case Experimental Design Exploring Dissociative Experiences and Voices Emerging empirical evidence has suggested that dissociation is a robust determinant of voice-hearing in psychosis, and that dissociation mediates the link between trauma and voices. Despite the emerging evidence-base, targeted therapeutic interventions focusing on dissociation remain largely untested. The aim of the current study is to investigate whether targeting dissociation leads to improvements in distressing voices in people with a history of trauma. This will be done by delivering an eight session intervention called 'CONNECT' to six individuals within the Glasgow Psychological Trauma Service (GPTS) who hear voices, have experienced trauma and are dissociating. The intervention will focus on learning strategies to manage dissociation. It is hypothesised that reduced levels of dissociation will be associated with reduction in the frequency and distress associated with hearing voices. This study will use a randomized multiple baseline single-case experimental design, meaning that participants will be randomly allocated to a baseline of two, three or four weeks and then will begin eight weeks of Connection to Environment Cognitive Therapy (CONNECT). As well as daily measures during baseline and intervention phases, there will be four assessment points (baseline, pre-intervention, post-intervention and follow-up). The study will take approximately three months plus follow-up one month after therapy ends. Individual levels of dissociation and voices will be compared during baseline and intervention periods using visual analysis and Tau-U. This study will contribute to the evidence-based for dissociation interventions targeting distressing voices among this population. It serves to investigate the proposed mechanism in a clinical population using a therapeutic intervention. It will therefore inform clinicians of the effectiveness and feasibility of using such strategies in clinical practice and may have good generalizability to practice.

NCT ID: NCT04054778 Recruiting - Clinical trials for Treatment-resistant Schizophrenia

Comparaison of Avatar Therapy to Cognitive Behavioral Therapy in Schizophrenia With Treatment Refractory Hallucinations

Phase3
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Schizophrenia is associated with long-lasting health, social and financial burden for patients, families, caregivers and society. According to the World Health Organization, this burdensome illness is one of the top 10 causes of disability in developed countries. The costs associated with hospitalization, lifelong treatment and loss of productivity lead to a great economic burden. In Canada, the total annual costs associated with schizophrenia are over $10 billion. The main reason for this heavy burden is that 25-30% of schizophrenia patients respond very poorly to antipsychotic medication. Moreover, psychotherapeutic treatment alternatives are very limited for this suffering population. This unmet clinical need requires innovation and action. Psychotherapeutic treatment alternatives such as Cognitive Behavior Therapy (CBT) are very limited and provide at best moderate results. Virtual reality (VR) opens new exciting avenues to treat this illness. With immersive VR, our team recently tested a novel psychotherapeutic intervention, Avatar Therapy (AT), where the therapist engages in a dialogue with the patient through a virtual representation of their distressing voice. This relational and experiential approach offers a unique opportunity to help patients gain control over their voice. The preliminary results of our randomized-controlled trial (RCT) pilot showed a large effect on auditory verbal hallucination for AT and a moderate effect for CBT. The main goal of the currently proposed RCT study will be to examine if AT is superior to CBT for the treatment of chronic auditory hallucinations in schizophrenia. As evidence-based therapeutic options are limited for this burdensome illness and provide only modest symptomatic relief, the current trial will contribute to the validation of a novel approach answering a fundamental clinical need. The demonstration of the superior efficacy of AT would be a great breakthrough and will open new avenues to clinical treatment.

NCT ID: NCT03852706 Terminated - Schizophrenia Clinical Trials

EEG-based Neurofeedback for Auditory Verbal Hallucinations (HALFEED)

HALFEED
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

This study's primary objective is to perform a randomized controlled pilot study to assess the feasibility of using EEG-based neurofeedback to reduce the severity of treatment-resistant auditory verbal hallucinations ('hearing voices') in patients diagnosed with schizophrenia. Patients will be randomized to receive either EEG-based neurofeedback or treatment-as-usual.

NCT ID: NCT03807388 Not yet recruiting - Schizophrenia Clinical Trials

ReMindCare App for Patients From First Episode of Psychosis Unit.

Start date: September 2019
Phase: N/A
Study type: Interventional

ReMindCare is an app designed by the Unit of Psychiatry at the Clinical Hospital of Valencia in liaison with the Polytechnic University of Valencia. This e-Health app gathers information about the clinical health status of patients with Psychotic Disorder Diagnose through daily and weekly brief assessments. This information is displayed in a restricted access website, where clinicians can visualize data from patients as well as download pdf reports of main data collected by the app. These reports can be attached to the electronic clinical report of the patient at the hospital database, being accessible for consultation for every clinician involved in treatment of the patient. Furthermore, ReMindCare produces different alarms which notify clinicians about variations into patients health status or the cessation of using the app. Moreover, patients can also deliberately generate an urgent consultation alarm. The introduction of ReMindCare app into clinical practice will follow a clinical trial structure in which treatment as usual (TAU) of patients from a First Episode of Psychosis Unit will be compared to ReMindCare app intervention program. After participants eligible for inclusion complete baseline assessments they will be randomly allocated to one of the two groups (Intervention or TAU) by a basic single blind randomization in which an independent researcher will perform the allocation using a computerized random number generator. Information collected through the app and variations into clinical data will be analyzed among time. First assessment of these data will be conducted after 6 months of patient´s enrollment into the study. Subsequent analysis will be conducted yearly.

NCT ID: NCT03762746 Recruiting - Clinical trials for Hallucinations, Verbal Auditory

Transcranial Magnetic Stimulation (TMS) for Patients With Treatment Resistant Auditory Verbal Hallucination

TMS
Start date: February 1, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the effect of repetitive transcranial magnetic stimulation (rTMS) in schizophrenia with treatment resistant auditory verbal hallucination

NCT ID: NCT03585127 Completed - Clinical trials for Treatment-resistant Schizophrenia

Avatar Therapy in Comparison to Cognitive Behavioral Therapy for Treatment-resistant Schizophrenia

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Schizophrenia is associated with long-lasting health, social and financial burden for patients, families, caregivers and society. Unfortunately, 25-30% of schizophrenia patients respond poorly to antipsychotic medication. Moreover, psychotherapeutic treatment alternatives are very limited for this suffering population. This unmet clinical need requires innovation and action. Psychotherapeutic treatment alternatives such as Cognitive Behavior Therapy (CBT) provide at best moderate results. Using immersive virtual reality, we recently tested a novel psychotherapeutic intervention, Avatar Therapy (AT), where the therapist engages in a dialogue with the patient through a virtual representation of the patient's distressing voice. This approach, being both relational and experiential, provides a unique opportunity to aid patients gain control over their voice. The results of our pilot study on AT were clinically promising for the severity and distress related to hallucinations, positive symptomatology and emotion regulation. To further research in this field, the primary goal of this randomized-controlled, single-site parallel study is to show that AT is superior to CBT for the treatment of persistent auditory hallucinations in schizophrenia. Our secondary goal is to examine the effects of these interventions on emotion regulation, mood symptoms (anxiety and depression), self-esteem, level of functioning and quality of life.

NCT ID: NCT03544333 Terminated - Schizophrenia Clinical Trials

Boost rTMS for Auditory Verbal Hallucinations

Start date: April 16, 2018
Phase: N/A
Study type: Interventional

This is a randomized, placebo controlled, double-blind clinical trial. The investigators aim to examine the safety and efficacy of repeated transcranial magnetic stimulation (rTMS) for the treatment of auditory verbal hallucinations (AVH) in patients with schizophrenia who are not taking antipsychotic medication. The investigators employ a novel, accelerated protocol with only four sessions of low-frequency rTMS in one day. The effects of this accelerated protocol will be compared to the sham stimulation. Additionally, the investigators will examine the effects of rTMS on a neurophysiological level by evaluating mechanism of action in the temporo-parietal lobe by means of functional magnetic resonance imaging.

NCT ID: NCT03519035 Not yet recruiting - Clinical trials for Borderline Personality Disorder

Study of Hallucinations in Patients With Borderline Personality Disorder

Start date: July 2018
Phase:
Study type: Observational [Patient Registry]

Hallucinations in borderline personality disorder are a frequent an serious trouble which have an important impact in patients lives. Despite this, they are often ignored by nursing staff, and are not an important criteria in Diagnostic and Statistical Manual (DSM) 5 and Classification Internationale des maladies (CIM-10). The main objective of our study is to assess the prevalence of this trouble in borderline personality disorder (BPD) population, and to characterize the hallucinations in order to compare our results with those of international studies.

NCT ID: NCT03504579 Completed - Schizophrenia Clinical Trials

Rt-fMRI Neurofeedback and AH in Schizophrenia

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Auditory hallucinations in schizophrenia are one of the major symptoms of this disease and a major source of psychological discomfort. They are often difficult or impossible to treat with existing methods. This study will test the use of real-time fMRI neurofeedback to mitigate auditory verbal hallucinations in patients whose hallucinations are resistant to medication. Half of the patients will receive real time fMRI neurofeedback from a brain region involved in auditory hallucinations and half will receive it from motor cortex.

NCT ID: NCT03485131 Completed - Schizophrenia Clinical Trials

Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations

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

This is a 4 week therapeutic pilot study with a 4 week follow-up period involving inpatients with treatment resistant DSM-IV schizophrenia or schizoaffective disorder diagnosis. Each eligible subject will receive either 20 minutes of active tDCS (transcranial direct-current stimulation) or sham stimulation twice a day on 5 consecutive weekdays for 4 weeks with a 4 week follow-up period.