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. 2018 Dec 20;2018(12):CD007964. doi: 10.1002/14651858.CD007964.pub2

Gleeson 2009.

Methods Allocation: randomised
 Blinding: assessor blind
Location: early Psychosis Prevention and Intervention Centre (EPPIC) in Melbourne and from Barwon Health, Victoria, Australia
Length of follow‐up: 30 months
Participants Diagnosis: schizophrenia (n = 27); schizophreniform (n = 9); schizoaffective disorder (n = 4); major depressive disorder with psychotic features (n = 5); bipolar disorder (n = 4); delusional disorder (n = 1); substance‐induced psychotic disorder (n = 3); psychotic disorder (n = 24)
N = 81
Sex: 51 M, 30 F
Age: mean ˜ 20.1 years, SD ˜ 2.9 years
Included: length of illness: not reported; less than 6 months of prior treatment with antipsychotic medications, age 15 to 25 years inclusive, and remission on positive symptoms of psychosis. Remission was defined as 4 weeks or more of scores of 3 (mild) or below on the subscale items hallucinations, unusual thought disorder, conceptual disorganisation, and suspiciousness on the expanded version of the Brief Psychiatric Rating Scale (BPRS).
 Excluded: ongoing active positive symptoms of psychosis, severe intellectual disability, inability to converse in or read English, and participation in previous CBT trials
Interventions 1. CBT group*: N = 41
Content: CBT focused upon relapse prevention although non‐adherence to treatment, substance abuse, coping with stress, and comorbid anxiety and depression were also targeted. There were parallel individual CBT sessions and family therapy sessions (based upon cognitive behavioural family therapy for schizophrenia (Falloon, 1988; Mueser & Glynn, 1999) where the family therapy focused upon communication skills, psychoeducation regarding relapse risk, and a review of early warning signs and documentation of a relapse prevention plan.
Delivered by: individual research therapist, who additionally adopted the role of outpatient case manager for the duration of their treatment at EPPIC
Frequency: 7‐month therapy window, approximately fortnightly
Treatment duration: 7 months
2. Standard care group: N = 40
Content: standard care was coordinated via an outpatient case manager and outpatient consultant psychiatrist, with access to home‐based treatment and a group programme as indicated. Standard care was manualised for case managers with specific guidelines regarding the frequency of follow‐up and an outline of the treatments that should be covered in relation to phases of recovery.
Delivered by: not reported
Frequency: nor reported
Treatment duration: 7 months
Outcomes Global state: relapse
Mental state: general (BPRS scores)
Functioning: social (SOFAS scores)
Quality of life: physical, psychological, social relationship, environment (WHOQOL‐BREF scores)
Satisfaction with treatment: leaving the study early
Engagement with services: compliance with medication/treatment (MARS scores)
Unable to use:
Mental state: negative symptom (SANS scores) ‐ no total endpoint score
Mental state: depression (MADRS scores) ‐ skewed data
Premorbid IQ: the Wechsler Test of Adult Reading (not predefined outcome for this review)
Substance use (clinician alcohol use scale, clinician drug use scale, Alcochol Use Disorders Identification Test, World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test) (not predefined outcome for this review).
Notes *Participants in the CBT group also received the standard care intervention..
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Random allocation was managed by the study statistician (SC) using computer generated random numbers." (p.478)
Comments: Randomisation was well conducted.
Allocation concealment (selection bias) High risk Quote: "The trial coordinator (DW), who was informed of the outcome of randomisation via email and telephone, informed the treating team and, in relevant cases, the research therapists of the outcome." (p.478)
Comments: Participants or investigators could possibly foresee assignments.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "The trial coordinator (DW), who was informed of the outcome of randomisation via email and telephone, informed the treating team and, in relevant cases, the research therapists of the outcome." (p.478)
Comments: Therapists knew the allocation assignment.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Outcome raters were kept blind to treatment allocation via (1) regular and frequent reminders were sent to all clinical staff regarding the importance of the blind; (2) the research assistant reminded participants. of the importance of the blind at the commencement of each research interview; (3) the research assistant was excluded from all clinical discussions regarding participants; and (4) the research assistant was forbidden from reading participants' medical records." (p.478)
Comments: Blinding of the outcome assessor was well conducted.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comments: Intention‐to‐treat analyses were provided. ITT employed a last‐observation‐carried‐forward procedure.
Selective reporting (reporting bias) Low risk Comments: All measured outcomes were reported.
Other bias Low risk Comments: none obvious