Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE September 23, 2019
Last Update Posted Date March 3, 2020
Estimated Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
Psychopathological Assessment [ Time Frame: Change: Baseline, 3, 6 weeks, 6 and 12 months] ]
Symptom Questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Psychotic Symptoms [ Time Frame: Change: Baseline, 3, 6 weeks, 6 and 12 months] ]
    Symptom Questionnaire
  • Insecurity- Self-confidence [ Time Frame: Change: Baseline, 3, 6 weeks, 6 and 12 months] ]
    Symptom Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality Avatar Therapy for People Hearing Voices
Official Title  ICMJE Virtual Reality Avatar Therapy for People Hearing Voices
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Psychosis
  • Schizophrenia
  • Schizo Affective Disorder
  • Hearing Voices When No One is Talking (Symptom)
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Virtual Reality Avatar Therapy (VRAT)
    • Behavioral: Assertiveness Training Program (ATP)
  • 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.
    Interventions:
    • Behavioral: Virtual Reality Avatar Therapy (VRAT)
    • Behavioral: Assertiveness Training Program (ATP)
Publications * Craig TK, Rus-Calafell M, Ward T, Leff JP, Huckvale M, Howarth E, Emsley R, Garety PA. AVATAR therapy for auditory verbal hallucinations in people with psychosis: a single-blind, randomised controlled trial. Lancet Psychiatry. 2018 Jan;5(1):31-40. doi: 10.1016/S2215-0366(17)30427-3. Epub 2017 Nov 23. Erratum in: Lancet Psychiatry. 2017 Nov 29;:.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephan T. Egger, MD +41523049340 stephan.egger@puk.zh.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04099940
Other Study ID Numbers  ICMJE VRAT- ATP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stephan T. Egger, Psychiatric University Hospital, Zurich
Study Sponsor  ICMJE Psychiatric University Hospital, Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Psychiatric University Hospital, Zurich
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP