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CompletedNCT01734291Updated Apr 5, 2017

Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

An interventional study of Family psychoeducation in Major Depressive Disorder, sponsored by Nagoya City University. Completed at 1 site in Japan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-04-05.

Sponsored by Nagoya City University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Family psychoeducation
  • Major depressive disorder
  • Family burden
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In context

Depression

8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 49 is below the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Nagoya City University is the lead sponsor of 14 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Patients who undergo electroconvulsive therapy (ECT) during the investigation period.
  2. Patients who are at serious suicidal risk.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Active comparator
    Family psychoeducation plus TAU

    Family psychoeducational therapy in addition to treatment as usual for the patients.

    Behavioral: Family psychoeducation

  • Placebo comparator
    Treatment as usual(TAU)

    Treatment as usual administered by physician and counseling administered by nurse.

    Behavioral: Family psychoeducation

Interventions

  • BehavioralFamily psychoeducation

    Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians

06

What researchers measure

Primary outcomes

  1. The change of total score of K6 of family members

    The K6 questionnaire is a six-item self-report questionnaire that was developed to screen for DSM-IV depressive and anxiety disorder.

    Time frame: The base line, 8, 16 and 32

Secondary outcomes

  1. The change of total score of Family Attitude Scale(FAS) of family members

    The Family Attitude Scale(FAS) is a 30-item self report inventory and measures families' Expressed Emotion(EE).

    Time frame: The base line, 8, 16 and 32

07

Study locations

1 site
  • Fujika Katsuki
    Nagoya, Aichi 467-8601, Japan
08

References and documents

Publications

  • 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. PubMed 25118129 ↗
  • 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. PubMed 29929495 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01734291
Lead sponsor
Nagoya City University
Responsible party
Fujika Katsuki (Associate Professor, Nagoya City University) — Principal investigator
First posted
Nov 27, 2012
Start date
Oct 1, 2012
Primary completion
Jun 20, 2016
Completion
Oct 9, 2016
Last update
Apr 5, 2017

Study contacts

Fujika Katsuki, Dr
principal investigator · Nagoya City University, School of Nursing

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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