NCT01734291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2016

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

3.7 years

First QC Date

November 21, 2012

Last Update Submit

April 3, 2017

Conditions

Major Depressive Disorder

Keywords

Family psychoeducationMajor depressive disorderFamily burden

Outcome Measures

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.

    The base line, 8, 16 and 32

Secondary Outcomes (1)

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

    The base line, 8, 16 and 32

Study Arms (2)

Family psychoeducation plus TAU

ACTIVE COMPARATOR

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

Behavioral: Family psychoeducation

Treatment as usual(TAU)

PLACEBO COMPARATOR

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

Behavioral: Family psychoeducation

Interventions

Family psychoeducationBEHAVIORAL

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

Family psychoeducation plus TAUTreatment as usual(TAU)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets the criteria for Major Depressive Disorder (MDD) according to DSM-IV.
  • Receives antidepressant therapy.
  • The patient had the first episode of MDD more than one year ago.
  • Currently fulfills the diagnostic threshold for major depressive episode or partial remission.
  • The patient and their family member(s) are aged between 18 and 85 years.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujika Katsuki

Nagoya, Aichi-ken, 467-8601, Japan

Location

Related Publications (2)

  • 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.

    PMID: 25118129BACKGROUND

  • 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.

    PMID: 29929495DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Fujika Katsuki, Dr

    Nagoya City University, School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 27, 2012

Study Start

October 1, 2012

Primary Completion

June 20, 2016

Study Completion

October 9, 2016

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

JP(1)