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Optimising AVATAR therapy for distressing voices

Optimising AVATAR therapy for distressing voices: study protocol for the AVATAR2 multi-centre randomised controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55682735
Enrollment
345
Registered
2020-01-22
Start date
2021-01-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

People with schizophrenia spectrum disorder or affective disorder with psychotic symptoms who have been experiencing distressing voices for longer than 6 months Mental and Behavioural Disorders Schizophrenia spectrum disorder or affective disorder with psychotic symptoms

Interventions

Current intervention as of 30/09/2020: People will be randomised to receive brief or extended AVATAR therapy added to Treatment As Usual (TAU) compared to TAU alone. Independent randomisation (King’s

Sponsors

King's College London
Lead Sponsor
South London and Maudsley NHS Foundation Trust
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18+ years 2. Currently under the care of a specialist mental health team (inpatient and outpatient settings) 3. Have current frequent and distressing voices, (as measured by a score of at least 2 on the sum of the intensity of distress and frequency items of the PSYRATS (Voices) scale), persisting for at least 6 months and in a language spoken by the therapist 4. Speak and read English to a sufficient level to provide consent and complete the assessment procedures 5. A clinical diagnosis of Schizophrenia spectrum disorder (ICD10 F20-29) or affective disorder with psychotic symptoms (ICD-10 F30–39, subcategories with psychotic symptoms)- as determined by clinical records

Exclusion criteria

Exclusion criteria: 1. Primary diagnosis of substance disorder, personality disorder or learning disability 2. Lacking capacity to consent 3. Profound visual/hearing impairment or insufficient comprehension of English to be able to engage in assessment or therapy 4. Currently undertaking individual psychological therapy for voices 5. Currently experiencing an acute mental health crisis

Design outcomes

Primary

MeasureTime frame
Distress associated with voices as measured by the Psychotic Symptoms Rating Scale- Auditory Hallucinations at 16 and 28 weeks

Secondary

MeasureTime frame
Current secondary outcome measures as of 19/11/2020: 1. Frequency of voices and overall severity as measured by the Psychotic Symptoms Rating Scale - Auditory Hallucinations frequency dimension and total score at baseline, 16 and 28 weeks 2. Remission of voices (standalone item) at baseline,16 and 28 weeks 3. Beliefs about Voices Revised (BAVQ-R) at baseline, 16 and 28 weeks 4. Voices acceptance and action scale (VAAS) at baseline, 16 and 28 weeks 5. First item from the Voice Power Differential Scale at baseline, 16 and 28 weeks 6. In daily life, occurrence of voices, associated distress and anxiety, using Experience Sampling Method at quasi-random occasions during the waking day over a 7-day period at baseline, 16 and 28-week assessment points 7. Wellbeing and patient-led outcome measures i.e. Warwick-Edinburgh Mental Well-being Scale, Choice of Outcome in CBT for Psychoses (CHOICE) at baseline, 16 and 28 weeks 8. Clinical characteristics and hypothesised sources of moderation of effects i.e. mood (Beck Depression Inventory), anxiety (DASS-21), delusions (PSYRATS), trauma (e.g. International Trauma Questionnaire and negative symptoms (Clinical Assessment Interview for Negative Symptoms) at baseline, 16 and 28 weeks Previous secondary outcome measures: 1. Frequency of voices as measured by the Psychotic Symptoms Rating Scale - Auditory Hallucinations at baseline, 16 and 28 weeks 2. Remission of voices (standalone item) at baseline,16 and 28 weeks 3. Beliefs about Voices Revised (BAVQ-R) at baseline, 16 and 28 weeks 4. Voices acceptance and action scale (VAAS) at baseline, 16 and 28 weeks 5. First item from the Voice Power Differential Scale at baseline, 16 and 28 weeks 6. In daily life, occurrence of voices, associated distress and anxiety, using Experience Sampling Method at quasi-random occasions during the waking day over a 7-day period at baseline, 16 and 28-week assessment points 7. Wellbeing and patient-led outcome measures i.e. Warwick-Edinburgh Mental Wel

Countries

England, Scotland, United Kingdom

Contacts

Public ContactClementine Edwards
clementine.edwards@kcl.ac.uk+44 (0)7557866053

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026