| Methods |
Allocation: randomisation without specification of methods. Duration: hospitalisation period (mean=36 days) plus18 month follow up.
Blinded assessments: reported
Analysis: Analysis of variance and analysis of covariance, correlation coeficients, chi‐square and t‐tests. ITT not used.
No of centres: 1
Country: USA |
| Participants |
Diagnosis: current bipolar disorder mood episode ‐ mania (DSM‐III)
N: 26 (experimental group n=15; control group n=11)
Mean (sd) age: 32.3 (15.4)
Gender: 14 (%) female
Race: 17 white
Setting: Payne Whitney Clinic, New York, USA.
History: 10 of them had had no previous episodes, 8 had had 1 or 2 previous episodes and 4 had had 3 or more previous episodes. |
| Interventions |
1 ‐ Standard multimodal hospital treatment (fixed drug regimen ‐ lithium 600‐2100mg/day, tricyclic antidepressants 100‐400mg/day, monoamine oxidase inhibitors 45‐90mg/day of phenelzine, antipsychotics in doses equivalent to 100‐800mg/day of chlorpromazine).
2 ‐ Standard multimodal hospital treatment plus the psychosocial family intervention for patient with his family Inpatient Family Intervention ( at least 6 45 minutes to 1 hour‐ manualized psychoeducational plus systemic‐dynamic interventions sessions, conducted by 2 therapists. |
| Outcomes |
USED:
1 ‐ Dropouts at discharging
2 ‐ Improvement clinically significant at discharge, 6 months.
NOT USED:
2 ‐ Improvement clinicaly significant at 18 months.
3 ‐ Family functioning measures |
| Notes |
26 patients were randomised but 5 withdrew and were not included in analysis |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
