Abstract

BackgroundMajor depressive disorder (MDD) is a long-lasting disorder with frequent relapses that have significant effects on the patient’s family. Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder. A previous randomized controlled trial has found that family psychoeducation is effective in enhancing the treatment of MDD. Although MDD can easily become a chronic illness, there has been no intervention study on the families of patients with chronic depression. In the present study, we design a randomized controlled trial to examine the effectiveness of family psychoeducation in improving the mental health of relatives of patients with MDD lasting more than one year.Methods/DesignParticipants are patients with MDD lasting more than one year and their relatives. Individually randomized, parallel-group trial design will be employed. Participants will be allocated to one of two treatment conditions: relatives will receive (a) family psychoeducation (four, two-hour biweekly multifamily psychoeducation sessions) plus treatment-as-usual for the patient (consultation by physicians), or (b) counseling for the family (one counseling session from a nurse) plus treatment-as-usual for the patient. The primary outcome measure will be relatives’ mental health as measured by K6 that was developed to screen for DSM-IV depressive and anxiety disorder. Additionally, the severity of depressive symptoms in patients measured by the Beck Depression Inventory–II (BDI-II) scale will be assessed. Data from the intention-to-treat sample will be analyzed 16 weeks after randomization.DiscussionThis is the first study to evaluate the effectiveness of family psychoeducation for relatives of patients with MDD lasting more than one year. If this type of intervention is effective, it could be a new method of rehabilitation for patients with MDD lasting more than one year.Trial registrationClinical Trials.gov NCT01734291 (registration date: 18 October 2012).

Highlights

  • Major depressive disorder (MDD) is a long-lasting disorder with frequent relapses that have significant effects on the patient’s family

  • This is the first study to evaluate the effectiveness of family psychoeducation for relatives of patients with MDD lasting more than one year

  • If this type of intervention is effective, it could be a new method of rehabilitation for patients with MDD lasting more than one year

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Summary

Discussion

One randomized controlled trial found that family psychoeducation is effective in enhancing the course of MDD [29]. There has been no intervention study on the mental health of families of patients with chronic depression. With such a background, this will be the world’s first study on family psychoeducation in families of patients with MDD. The method of family psychoeducation employed in this study is group therapy that improved the McFarlane model according to the Japanese Network of Psychoeducation and Family Support Program and focuses more on the strength of the family. An attention-placebo arm must be employed originally, we aim to conduct the study to examine the effectiveness of family psychoeducation for improvement of the mental health of relatives of patients with MDD, including eight-hour contact with medical professionals, but not to examine the efficacy of family psychoeducation for MDD itself.

Background
Methods/Design
20. Hooley JM
Findings
30. Pocock SJ

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