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Family Psychoeducation for Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT02348827
Recruitment Status : Unknown
Verified April 2016 by Mental Health Services in the Capital Region, Denmark.
Recruitment status was:  Recruiting
First Posted : January 28, 2015
Last Update Posted : April 29, 2016
Sponsor:
Collaborator:
Mental Health Centre North Zealand
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Family psychoeducation Behavioral: Social support group Not Applicable

Detailed Description:

More than 50 % of patients experiencing their first depressive episode will have at least one new episode. Therefore, effective interventions to reduce the risk of relapse are.

Psychoeducation is an interactive education form enhancing knowledge about patients' illness, including it course, symptoms and treatment.

Psychoeducational methods can also act as family intervention which already is an evidence-based practice in schizophrenia and bipolar disorder.

In spite of unipolar depression's high prevalence, only few studies have focused on the effect of psychoeducation, including family psychoeducation, in the prevention of new depressive episodes.

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.

The following hypotheses are proposed:

  1. Psychoeducational intervention for relatives will reduces the risk of depressive relapse (defined as a score on The Hamilton six-item subscale, HAM-D6≥7), among remitted depressed patients compared to the control condition
  2. Psychoeducational intervention for relatives will shorten time to achieve full symptomatic remission (defined as a score HAM-D6<5) among partially remitted depressed patients compared to the control condition
  3. Psychoeducational intervention for relatives will more effectively reduce depressive symptoms (measured on the HAM-D6) among patients fully symptomatic currently depressed patients, compared to control condition.

Secondary aims The study has as a secondary goal to investigate whether a high level of expressed emotion (EE) in relatives at baseline will be associated with poorer outcome, in the form of relapse, in depressed patients.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Family Psychoeducation for Major Depressive Disorder - a Randomized Controlled Trial
Study Start Date : January 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Family psychoeducation
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
Active Comparator: Social support group
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



Primary Outcome Measures :
  1. Number of relpase [ Time Frame: 9 months ]
    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.


Secondary Outcome Measures :
  1. Time to relapse [ Time Frame: Up to 9 months from baseline ]
    The number of weeks from baseline to relapse, time to full remission defined as a HAM-D6 <5, among the partially remitted patients (hypothesis 2)

  2. Reduction of depressive symptoms [ Time Frame: 9 months ]
    Reduction of depressive symptoms in the HAM-D6-score (hypothesis 3).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patients:

Inclusion Criteria:

  • 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

Regarding hypothesis 1 and 2, patients will be included if they are in remission or partial remission at the inclusion time defined as a score <13 on the Hamilton Rating Scale for Depression (HAM-D17) [20]. Patients included for the test of hypothesis 3 have a HAM-D17-score >13 at the time of the inclusion.

Exclusion Criteria:

  • 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:

Inclusion criteria:

• Age between 18 and 75

Exclusion criteria:

• Insufficient knowledge of Danish


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348827


Contacts
Contact: Nina Timmerby, MD +4538643197 nina.02.timmerby@regionh.dk

Locations
Denmark
Psychiatric Research Unit, Mental Health Centre North Zealand Recruiting
Hilleroed, Denmark, 3400
Contact: Nina Timmerby, MD    +4538643197    nina.02.timmerby@regionh.dk   
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
Mental Health Centre North Zealand
Investigators
Principal Investigator: Nina Timmerby Timmerby, MD Mental Health Centre North Zealand, Denmark

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT02348827     History of Changes
Other Study ID Numbers: H-4-2014-044
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016

Keywords provided by Mental Health Services in the Capital Region, Denmark:
Unipolar depression
Family Therapies
Psychoeducation
Family psychoeducation

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms