Schizophrenia spectrum disorder or affective disorder with psychotic symptoms Mental and Behavioural Disorders
Conditions
Interventions
Participants are randomized (1:1) to the AVATAR_VRSocial Therapy added to treatment as usual or treatment as usual.
Participants will be randomized once they have completed the baseline assessment. P
Sponsors
Ruhr University Bochum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have current frequent and distressing voices (as measured by a score of at least 1 on each intensity of distress and frequency items of the PSYRATS-AH), persisting for at least 6 months and speaking German 2. Confirmed diagnosis of affective and non-affective psychosis (F20-29, F32/33.3 and F31.2in ICD-10; World Health Organization, 1993) on the medical records or through consultation with the clinical team 3. With onset of the first psychotic episode or first presentation to mental health services in the last 5 years 4. =16 years old 5. Adequate German language skills to provide informed consent and engage with assessment and therapy sessions 6. To be able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Primary diagnosis of substance disorder, personality disorder or learning disability 2. Auditory verbal hallucinations (AVH) secondary to an organic disorder 3. Currently attending or to be confirmed to attend another individual psychological therapy for auditory verbal hallucinations 4. Profound visual/hearing impairment or insufficient comprehension of German to be able to engage in assessment or therapy 5. Currently experiencing an acute mental health crisis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures relate to the feasibility and acceptability of the trial procedures and intervention. The primary clinical outcome is distress associated with voices as measured by the Psychotic Symptoms Rating Scale - Auditory Hallucinations measured at baseline, 12 weeks and 24 weeks. Feasibility markers measured at baseline, 12 weeks and 24 weeks: 1. Recruitment and retention: number of patients identified, recruited, declined and retained 2. Referral procedure: number of referrals per month 3. Data collection methodology: completion rate of each assessment measure 4. Acceptability of the intervention: attendance at treatment sessions; feedback from qualitative interviews; Acceptability of Intervention Measure (AIM) and the Intervention Appropriateness Measure (IAM). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency of voices and overall severity as measured by the Psychotic Symptoms Rating Scale - Auditory Hallucinations frequency dimension and total score measured at baseline, 12 weeks and 24 weeks 2. Remission of voices (standalone item) measured using Hallucinations Remission Score at baseline, 12 weeks and 24 weeks 3. Beliefs about the voices measured using the Beliefs about Voices Revised (BAVQ-R) at baseline, 12 weeks and 24 weeks 4. Voices acceptance measured using the Voices acceptance and action scale (VAAS) at baseline, 12 weeks and 24 weeks 5. Voice power measured using the first item from the Voice Power Differential Scale at baseline, 12 weeks and 24 weeks 6. Agoraphobic avoidance measured using the Oxford – Agoraphobic Avoidance Scale (O-AS) at baseline, 12 weeks and 24 weeks 7. Worries before or when outside measured using the Oxford Cognitions and Defences Questionnaire (O-CDQ) at baseline, 12 weeks and 24 weeks 8. Negative voices when outside measured using the Brief assessment of negative hallucinations when outside, at baseline, 12 weeks and 24 weeks 7. Wellbeing measured using the Wellbeing EQ-5D-5L at baseline, 12 weeks and 24 weeks 8. Other psychopathology measured using DASS-21 at baseline, 12 weeks and 24 weeks 9. Delusions measured using the PSYRATS-Delusions at baseline, 12 weeks and 24 weeks 10. Trauma measured using the International Trauma Questionnaire at baseline, 12 weeks and 24 weeks 11. Negative symptoms measured using the Clinical Assessment Interview for Negative Symptoms at baseline, 12 weeks and 24 weeks | — |
Countries
Germany
Contacts
Public ContactMar Rus Calafell
Outcome results
None listed