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Virtual Reality Avatar Therapy for People Hearing Voices

Primary Purpose

Psychosis, Schizophrenia, Schizo Affective Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Virtual Reality Avatar Therapy (VRAT)
Assertiveness Training Program (ATP)
Sponsored by
Psychiatric University Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Hearing Voices, Virtual Reality Avatar Therapy, Cognitive Behavioural Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Psychiatrische Universitätsklinik ZürichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality Avatar Therapy (VRAT)

Assertiveness Training Program (ATP)

Arm Description

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.

The ATP is a transdiagnostic cognitive behavioural treatment programme, which aims to increase self-confidence and social competence in patients with a psychiatric disorder.

Outcomes

Primary Outcome Measures

Psychopathological Assessment
Symptom Questionnaire

Secondary Outcome Measures

Psychotic Symptoms
Symptom Questionnaire
Insecurity- Self-confidence
Symptom Questionnaire

Full Information

First Posted
September 18, 2019
Last Updated
September 26, 2023
Sponsor
Psychiatric University Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04099940
Brief Title
Virtual Reality Avatar Therapy for People Hearing Voices
Official Title
Virtual Reality Avatar Therapy for People Hearing Voices
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Psychiatric University Hospital, Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Schizophrenia, Schizo Affective Disorder, Hearing Voices When No One is Talking (Symptom)
Keywords
Hearing Voices, Virtual Reality Avatar Therapy, Cognitive Behavioural Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Avatar Therapy (VRAT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Assertiveness Training Program (ATP)
Arm Type
Active Comparator
Arm Description
The ATP is a transdiagnostic cognitive behavioural treatment programme, which aims to increase self-confidence and social competence in patients with a psychiatric disorder.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Avatar Therapy (VRAT)
Intervention Description
The Virtual Reality Avatar Therapy (VRAT) is a Cognitive Behavioral Intervention, delivered through Virtual Reality.
Intervention Type
Behavioral
Intervention Name(s)
Assertiveness Training Program (ATP)
Intervention Description
The Assertiveness Training Program (ATP) is a Cognitive Behavioral Intervention, delivered as group therapy.
Primary Outcome Measure Information:
Title
Psychopathological Assessment
Description
Symptom Questionnaire
Time Frame
Change: Baseline, 3, 6 weeks, 6 and 12 months]
Secondary Outcome Measure Information:
Title
Psychotic Symptoms
Description
Symptom Questionnaire
Time Frame
Change: Baseline, 3, 6 weeks, 6 and 12 months]
Title
Insecurity- Self-confidence
Description
Symptom Questionnaire
Time Frame
Change: Baseline, 3, 6 weeks, 6 and 12 months]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephan T. Egger, MD
Phone
+41523049340
Email
stephan.egger@puk.zh.ch
Facility Information:
Facility Name
Psychiatrische Universitätsklinik Zürich
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan T Egger, MD
Phone
+4152304940
Email
stephan.egger@puk.zh.ch
First Name & Middle Initial & Last Name & Degree
Godehard Weniger, MD
Phone
+41523049341
Email
godehard.weniger@puk.zh.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29175276
Citation
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;:
Results Reference
background
PubMed Identifier
33769295
Citation
Brander M, Egger ST, Hurlimann N, Seifritz E, Sumner RW, Vetter S, Magnenat S. Virtual Reality Human-Human Interface to Deliver Psychotherapy to People Experiencing Auditory Verbal Hallucinations: Development and Usability Study. JMIR Serious Games. 2021 Jun 1;9(2):e26820. doi: 10.2196/26820.
Results Reference
derived

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Virtual Reality Avatar Therapy for People Hearing Voices

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