| Methods |
Allocation: randomisation in a 2:1 formula, without mention about concealment procedures.
Blinded assessments: reported.
Duration: 6 months
Analysis: chi‐squared test, Students' t test, Mann‐Whitney U test, mixed analysis of variance.
No of centres: 1
Country: Spain |
| Participants |
Diagnosis: bipolar I and II disorder by SCID‐DSM‐IV, stabilized for at least 3 months (the participants of psychosocial intervention were the relatives and not the patients).
N: 45 (30 in experimental group and 15 in control group).
Age: Means (SD), for bipolar patients in experimental group 34.9(11.56) and in control group 35.9(7.52); for caregivers in experimental group 50.20(10.37) and in contrl group 45.07(16.25).
Gender: for bipolar patients in experimental group 12 women and 18 men and for control group 10 women and 5 men; for caregivers in experimental group 25 women and 5 men and for control group 9 women and 6 men.
Race: not mentioned.
Setting: hospital
History: Age of onset in means (SD) for experimental group 24.23((7.87) and for control group 23.00(7.17). Manic episodes 2.00(2.78) and 2.60(2.56) respectively. Hypomanic episodes 2.24(3.81) and 2.71(3.15) respectively. Depressive episodes 4.69(4.51) and 5.64(2.95) respectively. Mixed episodes 0.67(1.12) and 1.47(2.36) respectively. N of hospitalizations 1.67(1.32) and 2.36(1.78) respectively. |
| Interventions |
1‐ Psychoeducational Family Intervention: 12 psychoeducational 90‐min weekly group sessions taking place at hospital. In each group there were a maximum of 10 patients' relatives. The psychoeducation was structured. All patients (experimental and control) received standard pharmacologic treatment . 2 ‐ The relatives of control group received no psychoeducational intervention. The psychoeducational intervention was administered only for caregivers without the presence of patients. |
| Outcomes |
USED:
1 ‐ Relationships in the family invironment ‐ Cohesion, Expressiveness, Conflict ‐ (Family Environment Scale). 2 ‐ Dropouts of caregivers.
NOT USED:
3 ‐ Caregivers' knowledge of bipolar disorder (Bipolar Disorder Knowledge Questionnaire). 4 ‐ Caregivers' burden (Social Behavior Assessment Schedule). |
| Notes |
Only the relationships in the family invironment was included in this review because it seems to us to be the one with direct clinical relevance. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
