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. 2020 May 8;2020(5):CD011898. doi: 10.1002/14651858.CD011898.pub2

NCT03148639.

Study characteristics
Methods Allocation: randomised
Blindness: none
Duration: 7‐week phase IIa
Design: partial cross‐over
Country: Canada
Participants Diagnoses: schizophrenia or schizoaffective disorder
N= 19
Age: mean about 43 years
Sex: male and femaleb
Setting: Institut Universitaire en Santé Mentale de Montréal, Canada; institute and in community
History: treatment‐resistant schizophrenia, aged ≥ 18 years
Interventions 1. Avatar Therapy: participants created an avatar best resembling the most distressing person or entity believed to be the source of the malevolent voice, which was designed to closely have both the face and the voice of the "persecutor". Over the course of therapy, the avatar's interaction with the participant became gradually less abusive and more supportive. 1 avatar creation session + 6 weekly 45‐minute further sessions. N= 12.
2. Treatment as usual: antipsychotic treatment and usual meetings with their treating clinicians. N= 7.
Outcomes Mental state – general: PANSS, PSYRATS total
Mental state – specific (depression and anxiety): BDI
Mental state – specific (insight): BAVQ‐R
Mental state – specific (positive): PANSS
Global state: rehospitalised
Adverse events: various
Quality of life: QLESQ‐SF
Unable to use:
Mental state: self‐reported anxiety, fear – unable to extract data from graph
Notes Wrote to authors 24 November 2018 and Dr Laura Dellazizzo on behalf of Dr Alexandre Dumais, kindly replied supplying data on loss to follow‐up, rehospitalisation and Avatar Therapy group before crossover.
aThe total amount of weeks was 7 comprising of 1 avatar creation session and 6 therapeutic sessions.
bThere is no clear and detailed information about it from the baseline.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "patients fulfilling inclusion criteria were randomly allocated (1:1 ratio) to either VR‐assisted therapy (VRT) or treatment‐as‐usual (TAU)".
Comment: concern as the number of participants in 2 random groups are different which is not possible in 1:1 ratio.
Allocation concealment (selection bias) Unclear risk No information
Comment: unclear
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No information
Comment: unclear
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No information
Comment: unclear
Incomplete outcome data (attrition bias)
All outcomes High risk Comment: there was no information in the article because they had reported the crossover data (therapy +treatment as usual) as outcome report instead of reporting therapy outcome report separately. We contacted them via email for more information, and they kindly replied supplying data on loss to follow‐up, rehospitalisation and the mean outcome data for avatar therapy group before crossover, but unfortunately, they did not share the change data for this outcome with us.
Comment: high risk
Selective reporting (reporting bias) High risk Comment: there was no clear information regarding adverse events and number of participants.
Comment: high risk
Other bias Unclear risk Quote: "two of authors are holder of a grant from Otsuka Pharmaceuticals."
Comment: unclear

BAVQ‐R: Revised Beliefs about Voices Questionnaire; BDI: Beck Depression Inventory; CDS: Calgary Depression Scale; CI: confidence interval; DASS‐21: Depression, Anxiety and Stress Scale – 21 Items; ICD10 F20–29: International Classification of Diseases 10th Edition – Schizophrenia, schizotypal, delusional, and other non‐mood psychotic disorders; MANSA: Manchester Short Assessment of Quality of Life; MD: mean difference; N: number of participants; PANSS‐P: Positive and Negative Syndrome Scale – Positive; PSYRATS: Psychotic Symptom Rating Scale; QLESQ‐SF: Quality of Life Enjoyment and Satisfaction Questionnaire‐Short Form; RCT: randomised controlled trial; RD: risk difference; RR: risk ratio; RRPQ: Reactions to Research Participation Questionnaire; SANS: Scale for the Assessment of Negative Symptoms; SAPS: Scale for the Assessment of Positive Symptoms; SoCRATES: Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes; VAAS: Voices Acceptance and Action Scale; VPDS: Voice Power Differential Scale.