Clinical trial NCT04099940: Virtual Reality Avatar Therapy for People Hearing Voices
Official title: Virtual Reality Avatar Therapy for People Hearing Voices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Schizophrenia
Schizo Affective Disorder
Hearing Voices When No One is Talking (Symptom)
Keywords: Hearing Voices, Virtual Reality Avatar Therapy, Cognitive Behavioural Therapy
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Psychopathological Assessment
timeFrame: Change: Baseline, 3, 6 weeks, 6 and 12 months]
Secondary outcomes:
measure: Psychotic Symptoms
timeFrame: Change: Baseline, 3, 6 weeks, 6 and 12 months]
measure: Insecurity- Self-confidence
timeFrame: Change: Baseline, 3, 6 weeks, 6 and 12 months]
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Psychiatrische Universitätsklinik Zürich
Study officials:
References:
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.
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.