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Virtual reality therapy for voice hearing: a randomized controlled trial

Virtual reality therapy for voice hearing: a randomized controlled trial - VR-VOICES

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52102
Enrollment
112
Registered
2022-02-09
Start date
2022-10-17
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

auditory verbal hallucinations, Voicehearing Voicehearing

Interventions

• VR-VOICES intervention: 10-12 sessions (this includes the 2 booster session)&nbsp
of 45-60 minutes of individual VR assisted therapy in addition to treatment as&nbsp
usual (TAU).&nbsp
• Control: TAU as described in the current Dutch guidelines.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
16 Years to 99 Years

Inclusion criteria

Inclusion criteria: • DSM-5 diagnosis of a psychiatric disorder • Distressing AVH for minimally 3 months. • Age 16 years or older

Exclusion criteria

Exclusion criteria: • Insufficient command of the Dutch language • Unable to provide informed consent • Primary diagnosis of a substance use disorder, or organic brain disease (such  as dementia) • A degree of substance abuse that hinders treatment adherence • Auditory verbal hallucinations in a language not spoken by therapists • Patients cannot receive CBT specifically focussed at gaining empowerment over  voices.

Design outcomes

Primary

MeasureTime frame
Voices severity (frequency and distress): the total score on the auditory hallucinations scale of the Psychotic Symptoms Rating Scales (PSYRATS interview).

Secondary

MeasureTime frame
Auditory hallucinations: 1. Experience sampling method (ESM) of AVH, distress and anxiety measured in the flow of daily life. ESM is a structured diary method for reporting momentary experiences 18. Individuals complete short questionnaires on their mobile device, by pressing a link in a sms. Participants will complete ESM 8x daily for 7 days, completion takes ±1 minute. 2. Voice frequency, voice distress, delusions (subscales of the primary outcome PSYRATS) 3. Beliefs about voice power, voice intent and responding styles (Beliefs about Voices Questionnaire-Revised, BAVQ-R) 4. Social comparison with voices (Social Comparison Rating Scale To Voices, SCRS) 5. Impact of voice-hearing (Stemmen Impact Schaal, SIS) 6. Voices acceptance and action scale (VAAS) Clinical symptoms: 1. Depressive symptoms (Inventory of Depressive Symptomatology, IDS) 2. Paranoid ideation (Revised Green Paranoid Thoughts Scale, R-GPTS) 3. Self-esteem (Self Esteem Rating Scale, SERS) Care use, costs and quality of life: 1. Quality of life (EuroQol, EQ-5D-5L, Sheehan Disability Scale, SDS) 2. Health care costs and costs production losses (TiC-P) 3. Self-efficacy/empowerment (Mental Health Confidence Scale, MHCS) VR-VOICE group specific measurements: 1. Working Alliance Inventory, both for patient and therapist, completed at posttreatment. 2. Presence in 2 sessions (Igroup Presence Questionnaire, IPQ) 3. Experience of fit of the voice and avatar to the actual voice (two single items on a scale from 1-100), session duration, VR duration per session, goals, protocol deviations, notes and whether technical issues occurred • Subsample: After the VR-VOICES intervention, in-depth interviews will be performed to collect the experiences of patients with VR-VOICES. This will be done in a subsample of participants (n=20)

Countries

Netherlands

Contacts

Public ContactCNW Geraets

Universitair Medisch Centrum Groningen

c.n.w.geraets@umcg.nl0649231353

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)