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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
212
Seven 50-minute therapy sessions conducted by videoconferencing.
Seven 50-minute therapy sessions conducted by videoconferencing.
Swinburne University of Technology
Hawthorn, Victoria, Australia
RECRUITINGAuditory 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.
Time frame: Immediately post intervention (3 months), controlling for baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
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.
Time frame: 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.
Time frame: Baseline, immediately post intervention (3 months), follow-ups (6 and 9 months)
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