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Virtual Reality Avatar Therapy for People Hearing Voices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099940
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Stephan T. Egger, Psychiatric University Hospital, Zurich

Brief Summary:
Hearing voices is probably the worst form of acoustic hallucinations; which can be experienced as severely disturbing and is influenced by diverse factors including the ability of the individual to influence and control the hallucinatory experience itself. In recent years virtual reality has become a treatment option. In the so-called AVATAR Therapy, patients with schizophrenia and acoustic hallucinations design a visual and auditory recreation (avatar) of the entity to which they attribute their hallucinations. Working with a therapist over the course of several sessions, participants change the avatar from controlling to benevolent. Avatar Therapy involves similar processes to learning and cognitive restructuring, comparable to other psychotherapeutic interventions. The investigators plan to conduct an interventional study using a cross-over design, to compare the feasibility and efficacy of virtual reality avatar therapy for patients with acoustic hallucinations (independent of psychiatric diagnosis) with a cognitive behavioural group therapy aimed to improve social competence.

Condition or disease Intervention/treatment Phase
Psychosis Schizophrenia Schizo Affective Disorder Hearing Voices When No One is Talking (Symptom) Behavioral: Virtual Reality Avatar Therapy (VRAT) Behavioral: Assertiveness Training Program (ATP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The investigators plan to conduct a single-blind, randomised, controlled trial in a cross-over design to assess the feasibility and efficacy of VRAT in patients with acoustic hallucinations, independent of the main diagnosis.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Virtual Reality Avatar Therapy for People Hearing Voices
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual Reality Avatar Therapy (VRAT)
In the VRAT, patients with schizophrenia and acoustic hallucinations design a visual and auditory recreation (avatar) of the entity to which they attribute their hallucinations. Working with a therapist over the course of several sessions, participants change the avatar from controlling to benevolent.
Behavioral: Virtual Reality Avatar Therapy (VRAT)
The Virtual Reality Avatar Therapy (VRAT) is a Cognitive Behavioral Intervention, delivered through Virtual Reality.

Behavioral: Assertiveness Training Program (ATP)
The Assertiveness Training Program (ATP) is a Cognitive Behavioral Intervention, delivered as group therapy.

Active Comparator: Assertiveness Training Program (ATP)
The ATP is a transdiagnostic cognitive behavioural treatment programme, which aims to increase self-confidence and social competence in patients with a psychiatric disorder.
Behavioral: Virtual Reality Avatar Therapy (VRAT)
The Virtual Reality Avatar Therapy (VRAT) is a Cognitive Behavioral Intervention, delivered through Virtual Reality.

Behavioral: Assertiveness Training Program (ATP)
The Assertiveness Training Program (ATP) is a Cognitive Behavioral Intervention, delivered as group therapy.




Primary Outcome Measures :
  1. Psychopathological Assessment [ Time Frame: Change: Baseline, 3, 6 weeks, 6 and 12 months] ]
    Symptom Questionnaire


Secondary Outcome Measures :
  1. Psychotic Symptoms [ Time Frame: Change: Baseline, 3, 6 weeks, 6 and 12 months] ]
    Symptom Questionnaire

  2. Insecurity- Self-confidence [ Time Frame: Change: Baseline, 3, 6 weeks, 6 and 12 months] ]
    Symptom Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consistent acoustic hallucinations, with the presence of voices for at least two months.
  • Participants are competent to give informed consent, as determined by the referring physician or psychiatrist.
  • German language proficiency as a native speaker or level B1 Common European Framework of Reference for Languages (CEFRL)

Exclusion Criteria:

  • Current neurological disorder.
  • Current substance use or withdrawal.
  • Concomitant group psychotherapeutic intervention.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099940


Contacts
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Contact: Stephan T. Egger, MD +41523049340 stephan.egger@puk.zh.ch

Locations
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Switzerland
Psychiatrische Universitätsklinik Zürich
Zürich, Switzerland, 8032
Sponsors and Collaborators
Psychiatric University Hospital, Zurich
Publications:
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Responsible Party: Stephan T. Egger, Senior Psychiatrists, Psychiatric University Hospital, Zurich
ClinicalTrials.gov Identifier: NCT04099940    
Other Study ID Numbers: VRAT- ATP
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephan T. Egger, Psychiatric University Hospital, Zurich:
Hearing Voices, Virtual Reality Avatar Therapy, Cognitive Behavioural Therapy
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders