Family Psychoeducation for Major Depressive Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Family Psychoeducation for Major Depressive Disorder - a Randomized Controlled Trial

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Family psychoeducation
* Behavioral: Social support group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family psychoeducation<br>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<br> <br> |
| Active Comparator: Social support group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to relapse | 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) | Up to 9 months from baseline | 
| Reduction of depressive symptoms | Reduction of depressive symptoms in the HAM-D6-score (hypothesis 3). | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unipolar depression, Family Therapies, Psychoeducation, Family psychoeducation