Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Experiences of Hearing Voices

Study Overview
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Brief Summary
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The aim of this study is to compare the effects of a new psychological therapy, Avatar Therapy, to the current standard therapy, Cognitive Behavioural Therapy (CBT), in improving outcomes in people living with psychotic disorders who have persisting experiences of hearing voices (auditory verbal hallucinations, AVHs).

Detailed Description
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Continually hearing critical, abusive or threatening voices (auditory verbal hallucinations, AVHs) is a major persisting and disabling symptom of psychotic disorders such as schizophrenia. Current treatments have universally had only modest impact. In preliminary trials, a brief digitally supported treatment, using avatars to recreate AVHs during therapy, has produced some of the largest reductions in AVH severity seen to date. To definitively test the superiority of this innovative treatment, AMETHYST is a randomised controlled trial comparing avatar therapy to current recommended best practice treatment, CBT, for medication-resistant AVHs.

Official Title
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Remotely Delivered Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Auditory Hallucinations: Randomised Controlled Superiority Trial

Conditions
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Auditory Hallucination, Psychotic Disorders, Schizophrenia and Related Disorders

Intervention / Treatment
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* Behavioral: Avatar therapy
* Behavioral: Cognitive behavioural therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schizophrenia-related disorder or a mood disorder with psychotic symptoms diagnosis confirmed using the Structured Clinical Interview for DSM (SCID) Experiencing current auditory verbal hallucinations as measured by the Positive and Negative Syndrome Scale (PANSS) item P3 ≥ 4 Auditory verbal hallucinations present for at least one year Auditory verbal hallucinations include significant negative content (PSYRATS item 6 ≥ 2) Current treatment with antipsychotic medication at therapeutic levels as per RANZCP guidelines Access to the internet and a computer or other device on which videoconferencing software can be used Sufficient fluency in English for meaningful participation Age 18 or over Ability to give informed consent Exclusion Criteria: Auditory verbal hallucinations attributable to a primary substance use disorder or organic disorder Estimated full scale IQ < 70 (using the Test of Premorbid Functioning, TOPF) Within the last month or planned at the time of intake: a change of antipsychotic medication, Current or within the past 3 months receipt of individual psychological therapy for hearing voices, or receipt of electro-convulsive therapy or other brain stimulation treatment; AVHs in a language not spoken by the therapists.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: AMETHYST is a pragmatic, parallel group, randomised controlled superiority trial, comparing avatar therapy to CBT for persisting AVHs, with the primary outcome of post-intervention hallucination severity. In both arms, therapy will be delivered within a three-month period, with assessor-blinded assessments completed at baseline, post-intervention (3 months), and follow-ups (6 months and 9 months).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Behavioural Therapy (CBT)<br>The standard therapy arm will be based on a focused cognitive behavioural therapy (CBT) protocol for AVHs. Sessions will involve discussing the characteristics of participant's AVHs, before applying core CBT approaches, adapted to the AVH experience, to conduct a thorough cognitive behavioural assessment with a focus on coping strategy enhancement and cognitive restructuring. | Behavioral: Cognitive behavioural therapy (CBT)<br>* Seven 50-minute therapy sessions conducted by videoconferencing.<br>|
| Experimental: Avatar Therapy<br>The experimental arm will use avatar therapy. Sessions will involve generating an audio-visual avatar as a virtual representation of the primary 'voice' that the participant hears. This will be used to recreate AVHs experientially and allow participants to practice alternative ways of responding to the 'voice'. This innovative approach will be combined with the use of broader CBT methods. | Behavioral: Avatar therapy<br>* Seven 50-minute therapy sessions conducted by videoconferencing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) | Clinician-rated scale providing an index of overall severity based on 11 aspects of hallucinations (frequency, duration, intensity of distress, etc.), rated masked to treatment allocation. Each of the 11-items are scored on a 5-point scale (0 - 4), scores range from 0 to 44, with increased symptom expression indicated by higher scores. | Immediately post intervention (3 months), controlling for baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety symptoms, measured by the anxiety scale of the 21-item Depression Anxiety Stress Scale (DASS-21) | Self-report measure to assess depression, anxiety, and stress. Includes a total of 21-items that are scored on a 4-point scale (0 - 3). Scoring is made up of three sub scales that each include 7 items (Depression, Anxiety, and Stress). The scores for each of the three sub scales range from 0 to 42, with higher scores indicating increased symptom expression. | Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months) | 
| Personal recovery (consumer-defined recovery), measured by the Questionnaire for the Process of Recovery (QPR) | A self-report measure to assess consumer-defined recovery from psychosis. Includes 15-items that are rated on a 5-point scale, scores range (0-4), scores range from 0-60, with greater recovery indicated by higher scores. | Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months) | 
| Change in auditory verbal hallucination severity, measured by total score on the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) over follow-ups | Follow-up timepoints on the clinician rated scale that is used to measure the primary outcome. Includes 11-items that are scored on a 5-point scale (0 - 4), scores range from 0 to 44, with increased symptom expression indicated by higher scores. | Baseline, follow-ups (6 and 9 months) | 
| Change in auditory verbal hallucination-related distress, measured by the Psychotic Symptom Rating Scale - Auditory Hallucinations Scale (PSYRATS-AHS) Distress Score | Subscale of the clinician-rated scale that is used to measure the primary outcome. This includes 1-item that is scored on a 5-point scale (0 - 4), score ranges from 0 to 4, with increased symptom expression indicated by a higher score. | Baseline, immediately post intervention (3 months), and follow-ups (6 and 9 months) | 
| Remission of hallucinations, indexed by a score below 3 on the Hallucination scale of the Positive and Negative Syndrome Scales (PANSS) | Clinician-rated scale to assess presence and severity of hallucinations. This includes 1-item, scored from 1 to 7, with increased symptom expression indicated by higher scores. | Immediately post intervention (3 months), follow-ups (6 and 9 months) | 
| Change in overall psychosis symptom severity, measured by Positive and Negative Syndrome Scales (PANSS) total and sub scale scores | Clinician-rated scale to assess overall psychotic symptom severity on total and sub scale scores (Positive, Negative and General Psychopathology). Includes a total of 30-items that are scored on a 7-point scale (1 - 7). Total score ranges from 30 to 210; Positive and Negative sub scale scores range from 7 to 49; General Psychopathology sub scale scores range from 16 to 112. Higher scores are indicative of increased symptom expression. | Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months) | 
| Change in depressive symptoms, measured by the Calgary Depression Scale for Schizophrenia (CDSS) | Clinician-rated scale to assess depressive symptoms in schizophrenia. Includes a total of 9-items that are scored on a 4-point scale (0 - 3). Total score ranges from 0 to 27, with higher scores indicative of increased symptom expression. | Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auditory verbal hallucinations, Psychosis, Schizophrenia, Psychological therapy, Cognitive behavior therapy, Avatar therapy, Virtual reality, Telehealth