Virtual Reality Therapy for Voice Hearing (VR-VOICES): a Randomized Controlled Trial

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.

• Voice severity (frequency and distress) and delusions [Срок оценки: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
• Beliefs about voice power, voice intent and responding styles (Beliefs about Voices Questionnaire-Revised, BAVQ-R) [Срок оценки: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
• Social comparison with voices (Social Comparison Rating Scale To Voices, SCRS) [Срок оценки: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
• Impact of voice-hearing (Voice Impact Scale, VIS) [Срок оценки: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
• Voices acceptance (Voices Acceptance and Action scale, VAAS) [Срок оценки: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
• Depressive symptoms (Inventory of Depressive Symptomatology, IDS) [Срок оценки: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
• Paranoid ideation (Revised Green Paranoid Thoughts Scale, R-GPTS) [Срок оценки: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
• Self-esteem (Self Esteem Rating Scale, SERS) [Срок оценки: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
• Health care costs (Treatment Inventory of Costs in Patients with psychiatric disorders, TIC-P) [Срок оценки: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
• Costs production losses (Treatment Inventory of Costs in Patients with psychiatric disorders, TIC-P) [Срок оценки: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
• Quality of life (Sheehan Disability Scale, SDS) [Срок оценки: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]
• Quality of life (EuroQol, EQ-5D-5L) [Срок оценки: Assessment at baseline, 3 months (posttreatment), 6 months (follow-up)]