Clinical trial NCT01734291: Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression
Official title: Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Family psychoeducation
Major depressive disorder
Family burden
Lead sponsor: Nagoya City University
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of brief multifamily psychoeducation to relieve the psychological distress of families of patients with chronic major depression and to improve their family functioning.

Detailed description: Major depressive disorder (MDD) is a long-lasting illness with significant effects on the patient's family, social life, and work life. Treatment failure results in a low recovery rate and frequent relapses.

Relatives of patients with MDD are fraught with heavy psychosocial burden and show increased rates of depression and anxiety. Among relatives of patients with MDD, the patient's behavior and mood disturbance and relative's emotional distress were associated with the relatives' burden.

Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder. This intervention has been shown to reduce the rates of relapse and hospitalization among individuals with psychotic disorders and is recognized as an evidenced-based treatment for psychotic disorder. Several randomized controlled trials have found that family psychoeducation is effective in enhancing the course of bipolar disorder. However, there are few studies on psychoeducation of families of patients with MDD.

The purpose of this study is to examine the effectiveness of brief multifamily psychoeducation to relieve the psychological distress of families of patients with chronic major depression and to improve their family functioning, in a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

1. Meets the criteria for Major Depressive Disorder (MDD) according to DSM-IV.
2. Receives antidepressant therapy.
3. The patient had the first episode of MDD more than one year ago.
4. Currently fulfills the diagnostic threshold for major depressive episode or partial remission.
5. The patient and their family member(s) are aged between 18 and 85 years.
6. The patient has lived with his/her family at the time of participating in this study and is expected to live with his/her family during the investigation period.

Exclusion Criteria:

1. Patients who undergo electroconvulsive therapy (ECT) during the investigation period.
2. Patients who are at serious suicidal risk.

Primary outcomes:
measure: The change of total score of K6 of family members
timeFrame: The base line, 8, 16 and 32
Secondary outcomes:
measure: The change of total score of Family Attitude Scale(FAS) of family members
timeFrame: The base line, 8, 16 and 32
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Fujika Katsuki
state: Aichi
Study officials:
affiliation: Nagoya City University, School of Nursing
name: Fujika Katsuki, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katsuki F, Takeuchi H, Watanabe N, Shiraishi N, Maeda T, Kubota Y, Suzuki M, Yamada A, Akechi T. Multifamily psychoeducation for improvement of mental health among relatives of patients with major depressive disorder lasting more than one year: study protocol for a randomized controlled trial. Trials. 2014 Aug 12;15:320. doi: 10.1186/1745-6215-15-320.
citation: Katsuki F, Takeuchi H, Inagaki T, Maeda T, Kubota Y, Shiraishi N, Tabuse H, Kato T, Yamada A, Watanabe N, Akechi T, Furukawa TA. Brief multifamily Psychoeducation for family members of patients with chronic major depression: a randomized controlled trial. BMC Psychiatry. 2018 Jun 22;18(1):207. doi: 10.1186/s12888-018-1788-6.