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| ID | Type | Description | Link |
|---|---|---|---|
| 60-63600-98-1055 / 636320017 | Other Grant/Funding Number | ZonMW |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-VOICES | Experimental | 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. |
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| Treatment as usual | Other | 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. This will vary per individual. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR-VOICES | Behavioral | 7-10 individual VR assisted therapy for voice-hearing session and two booster sessions, in addition to TAU. |
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| Measure | Description | Time Frame |
|---|---|---|
| Voices severity | The Psychotic Symptoms Rating Scales (PSYRATS) is a semi-structured interview to assess characteristics of hallucinations and delusions. The auditory hallucinations subscale (AHS), which is used as the primary outcome, has 11 items. | Between baseline and posttreatment after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Voice severity (frequency and distress) and delusions | The Psychotic Symptoms Rating Scales (PSYRATS) is a semi-structured interview to assess characteristics of hallucinations and delusions. The auditory hallucinations subscale (AHS) has 11 items.The delusions subscale (DS) has six items. | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Trauma (Trauma and Life Events TALE) | 21 items on traumatic events, whether they happened, more than once and at which age. | Assessment at baseline |
| Trauma impact (Trauma screening questionnaire (TSQ) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chris Geraets, dr | Contact | 0031649231353 | c.n.w.geraets@umcg.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lentis | Not yet recruiting | Groningen | Provincie Groningen | Netherlands |
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| ID | Term |
|---|---|
| D006212 | Hallucinations |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual | Other | Treatment as usual as provided by the mental health centers |
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| Beliefs about voice power, voice intent and responding styles (Beliefs about Voices Questionnaire-Revised, BAVQ-R) | The BAVQ-R has 54 items, measured on a four-point scale: "disagree" (0), "unsure" (1), "slightly agree" (2), "strongly agree"(3). | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Social comparison with voices (Social Comparison Rating Scale To Voices, SCRS) | The SCRS has 11 items measuring characteristics of the participants as compared to their voices on a 10-point likert scale ranging from 1-10. | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Impact of voice-hearing (Voice Impact Scale, VIS) | The VIS has 24 items measured on a 10-point likert scale ranging from 1 (totally disagree) to 10 (totally agree). | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Voices acceptance (Voices Acceptance and Action scale, VAAS) | Section A of the VAAS has 12 items and section B 27. Items are rated on a 5-point scale: strongly disagree, disagree, unsure or neutral, or strongly agree. | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Depressive symptoms (Inventory of Depressive Symptomatology, IDS) | The IDS-SR is a 30-item questionnaire. Each item has four statements that reflect various degrees of symptom severity, scored on a four-point scale from 0 to 3. | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Paranoid ideation (Revised Green Paranoid Thoughts Scale, R-GPTS) | The R-GPTS part A consists of 8 items, and B of 10 items. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (totally). | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Self-esteem (Self Esteem Rating Scale, SERS) | The SERS has 20 items which are rated on a 7-point likert scale from 1 (strongly disagree) -7 (strongly agree). | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Health care costs (Treatment Inventory of Costs in Patients with psychiatric disorders, TIC-P) | The TiC-P is a self-report questionnaire that consists of two parts. The first part includes 38 structured questions, starting with yes/no questions and followed by a question on the volume of medical consumption. | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Costs production losses (Treatment Inventory of Costs in Patients with psychiatric disorders, TIC-P) | The TiC-P is a self-report questionnaire that consists of two parts. The second part deals with 12 questions about work to collect data on productivity losses due to health problems. | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Quality of life (Sheehan Disability Scale, SDS) | The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life on a scale from 0-10, and assess how many days someone missed work/school/responsibilities and how many days someone was unproductive. | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Quality of life (EuroQol, EQ-5D-5L) | The first 25 items of this questionnaires are based on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The patient is asked to indicate their health status by choosing the most appropriate level: no problems, slight problems, moderate problems, severe problems, and extreme problems. The last question indicates their current health status on a scale from 0 to 100. | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Empowerment/self-efficacy (Mental Health Confidence Scale, MHCS) | The MHCS has 16 items that are measured on a 6-point likert scale ranging from totally not confidant | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Experience sampling method (ESM) of auditory hallucinations and mental states | ESM of auditory verbal hallucinations and mental states 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 text message. Participants will complete ESM 5x daily for 7 days, completion takes ±1 minute. Participants have to complete the questionnaire within 30 minutes after the text message notification, the interval between measurements is 3 hours. | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
10 items to screen trauma which can be answered with yes or no.
| Assessment at baseline |
| Medication use | Use of prescribed medication in the past 3 months, type of medication, were the medication is for, how often it was used and what amount (in milligram) | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Substance use | Use of substances, number of glasses of alcohol in the past month. Use of softdrugs and harddrugs in the past 3 months, type of drugs, how often the drugs were used, how much was used each time. | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Frequency and type of interventions and training (questionnaire interventions and training) | Frequency of use of 21 types of psychological interventions and training in the past 30 days. There is also an option 'other', where specific other interventions and the frequency can be noted down. | Assessment at baseline, 3 months (posttreatment), 6 months (follow-up) |
| Working alliance VR-VOICES (Working Alliance Inventory,WAV) | The WAV has 36 items for the participant and 36 items for the therapist. Items are rated on a 5-point scale ranging from ''never'' to ''always'' | 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. |
| Presence in VR ((Igroup Presence Questionnaire, IPQ) | The IPQ has 14 items rated on 7-point likert scale ranging from fully disagree to fully agree. | 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. |
| Fit of avatar and voice. | Experience of fit of the voice and avatar to the actual voice (two single items on a scale from 1-100). | Assessment during VR-VOICES session 7 (only for the VR-VOICES group), which will be between 7and 10 weeks after baseline is completed. |
| Session information | Frequency and duration of use of the session recordings by the participant, duration, protocol deviations | Assessment during each VR-VOICES therapy session (only VR-VOICES group), between baseline and 3 months (follow-up) |
| Interview VR-VOICES | 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) | The interview takes place at 6 months (follow-up) and concerns the experience of the therapy |
| GGZ Drenthe | Recruiting | Assen | Netherlands |
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| University Medical Center Groningen | Recruiting | Groningen | 9712EW | Netherlands |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |