NCT02348827

Brief Summary

The aim of the present study is to compare an intervention consisting of Family Psychoeducation (FPE) to an active control intervention of social support for relatives of patients with a diagnosis of major depression.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

1.5 years

First QC Date

January 5, 2015

Last Update Submit

April 27, 2016

Conditions

Major Depressive Disorder

Keywords

Unipolar depressionFamily TherapiesPsychoeducationFamily psychoeducation

Outcome Measures

Primary Outcomes (1)

  • Number of relpase

    The primary outcome is relapse defined as a score ≥ 7 on HAM-D6 \[47\] in the 9-month follow-up period (hypothesis 1) among remitted patients.

    9 months

Secondary Outcomes (2)

  • Time to relapse

    Up to 9 months from baseline

  • Reduction of depressive symptoms

    9 months

Study Arms (2)

Family psychoeducation

EXPERIMENTAL

The intervention consists of group-based family psychoeducation-program aimed at the patients' relatives. Each group will consist of 5 participants and the patients will not be present at group sessions. The program consists of four weekly sessions each consisting of both short lectures on relevant topics as well as interactive séances designed to give participants problem-solving skills.

Behavioral: Family psychoeducation

Social support group

ACTIVE COMPARATOR

Relatives in the social support group will attend the same number of sessions of the same duration, as the relatives in the intervention group (family psychoeducation). The psychiatric nurse who will be in charge of the social support group will not give any psychoeducational intervention.

Behavioral: Social support group

Interventions

Family psychoeducationBEHAVIORAL
Family psychoeducation
Social support groupBEHAVIORAL
Social support group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75
  • Major depression diagnosis according to the ICD-10 established by a board certified psychiatrist and verified by the MINI International Neuropsychiatric Interview
  • Living together , or in very regular contact (every day or almost every day), with an adult relative that the patient considers as emotionally important and who are available for intervention

You may not qualify if:

  • Insufficient knowledge of Danish
  • Clinical suspicion of dementia
  • Alcohol, drug or medicine abuse
  • Psychotic symptoms
  • Co-morbidity of severe personality disorder
  • Having undergone ECT treatment during the index depressive episode
  • Maximum duration of the current depressive episode may not exceed 2 years
  • Maximum duration of a period with stable remission may not exceed 3 consecutive months
  • Regarding to the relatives following criteria for participation apply:
  • Age between 18 and 75
  • Insufficient knowledge of Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Research Unit, Mental Health Centre North Zealand

Hilleroed, 3400, Denmark

RECRUITING

Related Publications (1)

  • Timmerby N, Austin SF, Ussing K, Bech P, Csillag C. Family psychoeducation for major depressive disorder - study protocol for a randomized controlled trial. Trials. 2016 Aug 30;17(1):427. doi: 10.1186/s13063-016-1549-0.

    PMID: 27577267DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive Disorder

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Nina Timmerby Timmerby, MD

    Mental Health Centre North Zealand, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Timmerby, MD

CONTACT

+4538643197nina.02.timmerby@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 28, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2016

Study Completion

September 1, 2017

Last Updated

April 29, 2016

Record last verified: 2016-04

Locations

DK(1)