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Virtual Reality Avatar Therapy for People Hearing Voices

Sponsor
Psychiatric University Hospital, Zurich (Other)
Overall Status
Recruiting
CT.gov ID
NCT04099940
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
18
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual Reality Avatar Therapy (VRAT)
  • Behavioral: Assertiveness Training Program (ATP)
 N/A

Study Design

Study Type:
Interventional
Anticipated 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.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
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Psychopathological Assessment [Change: Baseline, 3, 6 weeks, 6 and 12 months]]

    Symptom Questionnaire

Secondary Outcome Measures

  1. Psychotic Symptoms [Change: Baseline, 3, 6 weeks, 6 and 12 months]]

    Symptom Questionnaire

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

    Symptom Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Psychiatrische Universitätsklinik Zürich Zürich Switzerland 8032

Sponsors and Collaborators

  • Psychiatric University Hospital, Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Stephan T. Egger, Senior Psychiatrists, Psychiatric University Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT04099940
Other Study ID Numbers:
  • VRAT- ATP
First Posted:
Sep 23, 2019
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stephan T. Egger, Senior Psychiatrists, Psychiatric University Hospital, Zurich
Hearing Voices, Virtual Reality Avatar Therapy, Cognitive Behavioural Therapy
Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mood Disorders

Study Results

No Results Posted as of Sep 16, 2021