May 1976.
Methods | Allocation: random, no further details. Blinding: single. Duration: until discharge or 6‐12 months. Post‐discharge follow up to 5 years. | |
Participants | Diagnosis: schizophrenia (clinical consensus); selected 'middle third of prognostic spectrum' (selection criteria unspecified). N=228. Age: range 16‐45 years. Sex: male and female. History: first admission, 'middle prognostic range', not remitted with average 14 day observation period. Excluded: people who were assessed as unlikely to be discharged within 2 years, and those whose illness went into remission during 14 day average assessment period. | |
Interventions | 1. Individual psychotherapy. N=46. 2. Ataraxic drugs (trifluoperazine). N=48. 3. Individual psychotherapy and ataraxic drugs. N=44. 4. ECT. N=47. 5. Milieu therapy and ataraxic drugs. N=43. |
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Outcomes | Leaving the study early Menninger Health‐Sickness Rating Scale (HSRS). | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised, no further details. |
Allocation concealment (selection bias) | Unclear risk | No further details. |
Blinding (performance bias and detection bias) All outcomes | High risk | Open study. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Study attrition not reported. Successive follow‐up studies have diminishing sample size. |
Selective reporting (reporting bias) | Unclear risk | No details. |
Other bias | High risk | Participants not representative of the whole range of “early episode psychosis”. Two‐thirds of first‐episode patients were excluded by trialists with the criteria used to select the "middle third of prognostic spectrum" not specified. Quote: “patients were excluded if there seemed little chance of their leaving the hospital within two years or if the illness was already remitting during the initial evaluation period (average, 18 days)” (p. 474). |