| Methods |
Allocation: randomisation without specification of methods.
Blinded assessments: reported only for pharmacologic outcomes.
Duration: 28 months
Analysis: survival analysis for time to recovery, cumulative probability of recovery estimated with Kaplan‐Meir product limit.
N of centres: 1
Country: USA |
| Participants |
Diagnosis: current bipolar I disorder mood episode, using the Structured Clinical Instrument for DSM‐III‐R‐Patient Version, current episode.
N = 92 (29 in 1‐pharmacotherapy alone; 33 in 2‐family therapy plus pharmacotherapy; 30 in 3‐multifamily psychoeducational group therapy plus pharmacotherapy ).
Age: 18‐65; means (SD) 39(13), 40(10), 39(12), for each group of comparison respectively.
Gender: for each group (female + male): (19 + 10); (15 + 18); (18 + 12), respectively.
Race: not informed.
Setting: tratment on outpatient basis; no more informations about setting.
History: Age of onset in mean of years (SD) ‐ with major depression in group 1: 20(8), group 2 25(10) and group 3 19(10); with mania in group 1 27(10), in group 2 29(10) and group 3 29(11). Lifetime number of episodes of major depression in means (SD): group 1 6(9), in group 2 5(5) and in group 3 10(12). Lifetime number of episodes of mania in means (SD): in group 1 4(3), in group 2 5(6) and in group3 6(5). Lifetime number of hospitalizations in means (SD): in group 1 5(5), in group 2 4(3) and in group 3 4(4).
Education years, means (SD): 12.3 (2); 13 (3); 14 (2) respectively for group 1, 2 and 3. |
| Interventions |
1 ‐ Pharmacotherapy alone: mood stabilizers and other medications based on type, intensity and duration of symptoms. 2 ‐ Problem Centered Systems Therapy of the Family (semi‐structured with manual) ‐ 6 to 10 sessions (50 minutes), plus pharmacotherapy. 3 ‐ Multifamily Psychoeducational Group Therapy (semi‐structured with manual) ‐ 6 weekly topic sessions (90 minutes), plus pharmacotherapy. |
| Outcomes |
USED:
1 ‐ Recovery for all patients after 28 months, using the Modified Hamilton Rating Scale for Depression and Bech‐Rafaelsen Mania Scale. Recovery definied as two consecutive months with scores < 7 in Hamilton and < 6 in Bech‐Rafaelsen.
2 ‐ Recovery for the subjects with mania after 28 mths: assessed in the same way described above.
3 ‐ Dropouts (patients that did not stay in the study for at least 6 months).
NOT USED:
4 ‐ Time to recovery (median time) for all patients.
5 ‐ Time to recovery (median time) for subjects with mania. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
