Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

NCT ID: NCT01734291

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-01

Study Completion Date

2016-10-09

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Family psychoeducation plus TAU

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

Group Type ACTIVE_COMPARATOR

Family psychoeducation

Intervention Type BEHAVIORAL

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

Treatment as usual(TAU)

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

Group Type PLACEBO_COMPARATOR

Family psychoeducation

Intervention Type BEHAVIORAL

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

Interventions

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Family psychoeducation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nagoya City University

OTHER

Sponsor Role lead

Responsible Party

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Fujika Katsuki

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fujika Katsuki, Dr

Role: PRINCIPAL_INVESTIGATOR

Nagoya City University, School of Nursing

Locations

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Fujika Katsuki

Nagoya, Aichi-ken, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 25118129 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29929495 (View on PubMed)

Other Identifiers

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ID24593499

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCUPsychiatricNursing001

Identifier Type: -

Identifier Source: org_study_id

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