PsychosisNCT04099940
Virtual Reality Avatar Therapy for People Hearing Voices
A study testing Virtual Reality Avatar Therapy (VRAT) and Assertiveness Training Program (ATP) in people with Psychosis and Schizophrenia, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis, Schizophrenia, Schizo Affective Disorder
- What is being tested?
- Virtual Reality Avatar Therapy (VRAT) and Assertiveness Training Program (ATP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Current neurological disorder.
- Current substance use or withdrawal.
- Concomitant group psychotherapeutic intervention.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Psychiatrische Universitätsklinik Zürich
Zurich, 8032
Stephan T Egger, MD, +4152304940, stephan.egger@puk.zh.ch
Godehard Weniger, MD, +41523049341, godehard.weniger@puk.zh.ch
About this study
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.
- Conditions
- Psychosis, Schizophrenia, Schizo Affective Disorder, Hearing Voices When No One is Talking (Symptom)
- Being tested
- Virtual Reality Avatar Therapy (VRAT), Assertiveness Training Program (ATP)
- Keywords
- Hearing Voices, Virtual Reality Avatar Therapy, Cognitive Behavioural Therapy
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Avatar Therapy (VRAT)Behavioural
The Virtual Reality Avatar Therapy (VRAT) is a Cognitive Behavioral Intervention, delivered through Virtual Reality.
Assertiveness Training Program (ATP)Behavioural
The Assertiveness Training Program (ATP) is a Cognitive Behavioral Intervention, delivered as group therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Virtual Reality Avatar Therapy (VRAT); Behavioral: Assertiveness Training Program (ATP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychopathological Assessment
Symptom Questionnaire
Measured: Change: Baseline, 3, 6 weeks, 6 and 12 months]
Secondary outcomes (2)
Psychotic Symptoms
Symptom Questionnaire
Measured: Change: Baseline, 3, 6 weeks, 6 and 12 months]
Insecurity- Self-confidence
Symptom Questionnaire
Measured: Change: Baseline, 3, 6 weeks, 6 and 12 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Jul 2021
- Primary completion30 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatric University Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan T. Egger, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099940
- Sponsor's protocol ID
- VRAT- ATP
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29175276Brander 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.
PubMed 33769295
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Avatar Therapy for People Hearing Voices
- ClinicalTrials.gov ID
- NCT04099940
- Acronym / sponsor ID
- VRAT- ATP
- Conditions
- Psychosis, Schizophrenia, Schizo Affective Disorder, Hearing Voices When No One is Talking (Symptom)
- Keywords
- Hearing Voices, Virtual Reality Avatar Therapy, Cognitive Behavioural Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Psychiatric University Hospital, ZurichUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Avatar Therapy (VRAT) | Experimental | Behavioral: Virtual Reality Avatar Therapy (VRAT), Behavioral: Assertiveness Training Program (ATP)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. |
| Assertiveness Training Program (ATP) | Active comparator | Behavioral: Virtual Reality Avatar Therapy (VRAT), Behavioral: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Current neurological disorder.
- Current substance use or withdrawal.
- Concomitant group psychotherapeutic intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Avatar Therapy (VRAT)The Virtual Reality Avatar Therapy (VRAT) is a Cognitive Behavioral Intervention, delivered through Virtual Reality. | Behavioural | Assertiveness Training Program (ATP), Virtual Reality Avatar Therapy (VRAT) |
| Assertiveness Training Program (ATP)The Assertiveness Training Program (ATP) is a Cognitive Behavioral Intervention, delivered as group therapy. | Behavioural | Assertiveness Training Program (ATP), Virtual Reality Avatar Therapy (VRAT) |
Primary outcome
Psychopathological Assessment
Time frame: Change: Baseline, 3, 6 weeks, 6 and 12 months]
Symptom Questionnaire
2 secondary outcomes
Psychotic Symptoms
Time frame: Change: Baseline, 3, 6 weeks, 6 and 12 months]
Insecurity- Self-confidence
Time frame: Change: Baseline, 3, 6 weeks, 6 and 12 months]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 29175276Craig 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.
- Derived from this study: PubMed 33769295Brander 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.
- Individual participant dataSharing planned: No
Related trials for Psychosis
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Avatar Therapy (VRAT) and Assertiveness Training Program (ATP) in people with Psychosis and Schizophrenia, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephan T. Egger, MD (+41523049340, stephan.egger@puk.zh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychopathological Assessment (time frame: Change: Baseline, 3, 6 weeks, 6 and 12 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04099940, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.