NCT03148639.
Study characteristics | ||
Methods | Allocation: randomised Blindness: none Duration: 7‐week phase IIa Design: partial cross‐over Country: Canada |
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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 |
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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. |
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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 |
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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. |
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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.