NCT04099940

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

3.9 years

First QC Date

September 18, 2019

Last Update Submit

September 26, 2023

Conditions

Keywords

Hearing Voices, Virtual Reality Avatar Therapy, Cognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (1)

  • Psychopathological Assessment

    Symptom Questionnaire

    Change: Baseline, 3, 6 weeks, 6 and 12 months]

Secondary Outcomes (2)

  • Psychotic Symptoms

    Change: Baseline, 3, 6 weeks, 6 and 12 months]

  • Insecurity- Self-confidence

    Change: Baseline, 3, 6 weeks, 6 and 12 months]

Study Arms (2)

Virtual Reality Avatar Therapy (VRAT)

EXPERIMENTAL

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)Behavioral: Assertiveness Training Program (ATP)

Assertiveness Training Program (ATP)

ACTIVE COMPARATOR

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)Behavioral: Assertiveness Training Program (ATP)

Interventions

The Virtual Reality Avatar Therapy (VRAT) is a Cognitive Behavioral Intervention, delivered through Virtual Reality.

Assertiveness Training Program (ATP)Virtual Reality Avatar Therapy (VRAT)

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

Assertiveness Training Program (ATP)Virtual Reality Avatar Therapy (VRAT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatrische Universitätsklinik Zürich

Zurich, 8032, Switzerland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 29175276BACKGROUND
  • 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.

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaHallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Stephan T. Egger, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Psychiatrists

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 23, 2019

Study Start

July 1, 2021

Primary Completion

May 30, 2025

Study Completion

December 31, 2025

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations