| Methods |
Allocation: randomisation procedure using random number table. Randomisation sequence was concealed until assignments had been made. Duration: 9 months for therapy and 2 years of total follow up. Blinded assessments: reported. Analysis: Survival analysis using Kaplan‐Meier product‐limit formula and Cox proportional hazards models when incorporating covariates; mixed analysis of variance; ITT for survival analysis.
No of centres: not clear.
Country: USA |
| Participants |
Diagnosis: bipolar disorder (post‐episode phases) DSM‐III‐R (SCID‐P). A posteriori confirmation by DSM‐IV showed that two patients of the sample were bipolar II while the others (99) were bipolar I.
N: 101 (experimental group n=31; control group n=70).
Age: 18‐62 years (mean 35.6 sd 10.2).
Gender: 64 women and 37 men.
Setting: Family interventions performed at patients' homes.
Race: not informed.
History: mania, depression or mixed episode within the past 3 months, living with or in regular contact with a caregiving family member, willingness to take medication, english speaking. Excluded disability or neurologic disorder, alcohol or substance abuse disorder within the previous 6 months. |
| Interventions |
1 ‐ Family‐Focused Therapy: 21 sessions (psychoeducation, communication enhancement training, problem‐solving skills training; 12 weekly, 6 biweekly, 3 monthly ‐ one‐hour). 2 ‐ Crisis Management: 2 one‐hour home based sessionsof family psychoeducation (within 2 months after entry) and more crisis intervention sessions during the rest of 9 months if necessary. All patients in both groups were receiving pharmacologic treatment (mood‐stabilizers and/or antipsychotics, antidepressants). |
| Outcomes |
USED:
1 ‐ Relapse at the end of treatment (24 months) ‐
symptoms: SADS‐C (ranging from 1 (absent) to 7 (very extreme).
2 ‐ Medication compliance during follow up: all available compliance data and laboratory results were assembled into a dosier and assigned a 3‐point adherence rating ‐ 1 is fully nonadherent, 2 is partially nonadherent and 3 is fully adherent.
3 ‐ Dropouts
NOT USED:
4 ‐ Rehospitalization
5 ‐ Time to relapse ‐ survival analysis |
| Notes |
We have considered as relapsed the patients that have have been computed as dropouts during the study duration. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
