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
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Behavioral: Family psychoeducation Behavioral: Social support group||Not Applicable|
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:
- 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
- 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
- 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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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
- Number of relpase [ Time Frame: 9 months ]The primary outcome is relapse defined as a score ≥ 7 on HAM-D6  in the 9-month follow-up period (hypothesis 1) among remitted patients.
- 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)
- Reduction of depressive symptoms [ Time Frame: 9 months ]Reduction of depressive symptoms in the HAM-D6-score (hypothesis 3).
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
|Contact: Nina Timmerby, MDfirstname.lastname@example.org|
|Psychiatric Research Unit, Mental Health Centre North Zealand||Recruiting|
|Hilleroed, Denmark, 3400|
|Contact: Nina Timmerby, MD +4538643197 email@example.com|
|Principal Investigator:||Nina Timmerby Timmerby, MD||Mental Health Centre North Zealand, Denmark|