Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013748
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2023-07-18
Brief Title:
Virtual Reality Therapy for Voice Hearing VR-VOICES a Randomized Controlled Trial
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Virtual Reality Therapy for Voice Hearing VR-VOICES a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR-VOICES
Brief Summary:
Rationale 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 the potential to improve this treatment Therefore we developed a novel VR treatment for this problem In this study the effect of this treatment will be investigated
Objective To test the effect of a novel VR treatment for AVH VR-VOICES on distress and frequency of AVH in patients with a psychiatric disorder Furthermore to investigate the effect of VR-VOICES on clinical symptoms quality of life and healthcare costs of the treatment
Objective To test the effect of a novel VR treatment for AVH VR-VOICES on distress and frequency of AVH in patients with a psychiatric disorder Furthermore to investigate the effect of VR-VOICES on clinical symptoms quality of life and healthcare costs of the treatment
Detailed Description:
Study design Single-blind randomized controlled intervention trial RCT with two arms VR-VOICES as intervention and treatment as usual TAU as a control condition
Study population Patients with a DSM-5 diagnosis who have experienced distressing AVH for at least 3 months who are 16 years or older N112
Intervention
VR-VOICES intervention 7-10 sessions of 45-60 minutes of individual VR assisted therapy and two booster sessions in addition to TAU Participants allocated to VR-VOICES create together with their therapist a VR digital representation avatar with face body and voice of the voice that bothers them most Patients have dialogues with the avatar voiced by the therapist As indicated in the treatment protocol over the sessions the avatar will become less hostile and the participant will gain more power and resilience over the avatar
Control TAU as described in the current Dutch treatment guidelines which generally exists of pharmacological treatment supportive counseling and psychological interventions such as CBT and coping strategies
Main study parametersendpoints Assessments will be obtained at baseline within some VR-VOICES sessions posttreatment 12 weeks after baseline and at 6-month follow-up Primary outcome severity of AVH total score on the auditory hallucinations scale of the PSYRATS at post-treatment Secondary outcomes in-depth characteristics of AVH such as the frequency voice impact beliefs about voices power relative to voices levels of anxiety distress and impact on daily life as measured with questionnaires and diary assessments in the flow of daily life Other secondary outcomes include clinical symptoms cost-effectiveness and quality of life
Study population Patients with a DSM-5 diagnosis who have experienced distressing AVH for at least 3 months who are 16 years or older N112
Intervention
VR-VOICES intervention 7-10 sessions of 45-60 minutes of individual VR assisted therapy and two booster sessions in addition to TAU Participants allocated to VR-VOICES create together with their therapist a VR digital representation avatar with face body and voice of the voice that bothers them most Patients have dialogues with the avatar voiced by the therapist As indicated in the treatment protocol over the sessions the avatar will become less hostile and the participant will gain more power and resilience over the avatar
Control TAU as described in the current Dutch treatment guidelines which generally exists of pharmacological treatment supportive counseling and psychological interventions such as CBT and coping strategies
Main study parametersendpoints Assessments will be obtained at baseline within some VR-VOICES sessions posttreatment 12 weeks after baseline and at 6-month follow-up Primary outcome severity of AVH total score on the auditory hallucinations scale of the PSYRATS at post-treatment Secondary outcomes in-depth characteristics of AVH such as the frequency voice impact beliefs about voices power relative to voices levels of anxiety distress and impact on daily life as measured with questionnaires and diary assessments in the flow of daily life Other secondary outcomes include clinical symptoms cost-effectiveness and quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 60-63600-98-1055 636320017 | OTHER_GRANT | ZonMW | None |