To investigate whether VR-VOICES is more effective than regular treatment for voicehearing in patients with auditory hallucinations.
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Voices severity (frequency and distress): the total score on the auditory
hallucinations scale of the Psychotic Symptoms Rating Scales (PSYRATS
interview).
Secondary outcome
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)
Background summary
Auditory verbal hallucinations (AVH) - hearing voices that others cannot hear -
are common in mental illnesses. For many people AVH are distressing, disabling
and persistent, despite medication. Current psychological interventions show
low to medium effects. Preliminary studies suggest that an innovative
empowering psychological therapy using computer simulations representing the
AVH (avatars) can be effective for reducing AVH distress and frequency. Virtual
reality (VR) has a potential to improve this treatment.
Study objective
To investigate whether VR-VOICES is more effective than regular treatment for
voicehearing in patients with auditory hallucinations.
Study design
Single-blind randomized controlled intervention trial (RCT).
Intervention
• VR-VOICES intervention: 10-12 sessions (this includes the 2 booster session)
of 45-60 minutes of individual VR assisted therapy in addition to treatment as
usual (TAU).
• Control: TAU as described in the current Dutch guidelines.
Study burden and risks
The participating patients are expected to benefit from both the VR-VOICES
intervention and TAU. Concerning VR-VOICES, exposure to the avatar's voice is
expected to be distressing, especially in the first two weeks. However, the
exposure is provided in a controlled fashion and through the guidance of the
therapist, and the exposure can be stopped at any time instantly by the
therapist or participant. Previous RCT and pilot studies reported no SAEs to be
attributable to the therapy (n=121 have been treated with the therapy over
these three trials). Furthermore, VR which is a rapidly expanding field, has
been found safe to use for multiple disorders.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
• DSM-5 diagnosis of a psychiatric disorder
• Distressing AVH for minimally 3 months.
• Age 16 years or older
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78885.042.22 |