Clinical trial NCT06013748: Virtual Reality Therapy for Voice Hearing (VR-VOICES): a Randomized Controlled Trial
Official title: Virtual Reality Therapy for Voice Hearing (VR-VOICES): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hallucinations, Verbal Auditory
Keywords: Virtual reality
Auditory hallucination
Voice-hearing
Psychological intervention
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-08-28
Enrollment: 112
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 (N=112).

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 parameters/endpoints: 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.

Eligibility criteria: Inclusion Criteria:

* Having a 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 focused at gaining empowerment over voices during the study period or 6 months prior to enrolment.

Primary outcomes:
measure: Voices severity
timeFrame: Between baseline and posttreatment after 3 months
Secondary outcomes:
measure: Voice severity (frequency and distress) and delusions
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Beliefs about voice power, voice intent and responding styles (Beliefs about Voices Questionnaire-Revised, BAVQ-R)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Social comparison with voices (Social Comparison Rating Scale To Voices, SCRS)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Impact of voice-hearing (Voice Impact Scale, VIS)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Voices acceptance (Voices Acceptance and Action scale, VAAS)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Depressive symptoms (Inventory of Depressive Symptomatology, IDS)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Paranoid ideation (Revised Green Paranoid Thoughts Scale, R-GPTS)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Self-esteem (Self Esteem Rating Scale, SERS)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Health care costs (Treatment Inventory of Costs in Patients with psychiatric disorders, TIC-P)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Costs production losses (Treatment Inventory of Costs in Patients with psychiatric disorders, TIC-P)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Quality of life (Sheehan Disability Scale, SDS)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Quality of life (EuroQol, EQ-5D-5L)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Empowerment/self-efficacy (Mental Health Confidence Scale, MHCS)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Experience sampling method (ESM) of auditory hallucinations and mental states
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
Other outcomes:
measure: Trauma (Trauma and Life Events TALE)
timeFrame: Assessment at baseline
measure: Trauma impact (Trauma screening questionnaire (TSQ)
timeFrame: Assessment at baseline
measure: Medication use
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Substance use
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Frequency and type of interventions and training (questionnaire interventions and training)
timeFrame: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)
measure: Working alliance VR-VOICES (Working Alliance Inventory,WAV)
timeFrame: Assessment at the end of VR-VOICES session 7 (only for the VR-VOICES group), which will be between 7and 10 weeks after baseline is completed.
measure: Presence in VR ((Igroup Presence Questionnaire, IPQ)
timeFrame: Assessment during VR-VOICES session 3 & 7 (only for the VR-VOICES group), , which will be between 3-7 weeks (for session 3) and 7-10 weeks (for session 7) after baseline is completed.
measure: Fit of avatar and voice.
timeFrame: Assessment during VR-VOICES session 7 (only for the VR-VOICES group), which will be between 7and 10 weeks after baseline is completed.
measure: Session information
timeFrame: Assessment during each VR-VOICES therapy session (only VR-VOICES group), between baseline and 3 months (follow-up)
measure: Interview VR-VOICES
timeFrame: The interview takes place at 6 months (follow-up) and concerns the experience of the therapy
Locations:
city: Assen
country: Netherlands
facility: GGZ Drenthe
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Groningen
country: Netherlands
facility: Lentis
Study officials:
References: