Major Depressive Disorder
Conditions
Keywords
Unipolar depression, Family Therapies, Psychoeducation, Family psychoeducation
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.
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.
Interventions
BEHAVIORALFamily psychoeducation
BEHAVIORALSocial support group
Sponsors
Mental Health Centre North Zealand
Mental Health Services in the Capital Region, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of relpase | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to relapse | 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 | 9 months | Reduction of depressive symptoms in the HAM-D6-score (hypothesis 3). |
Countries
Denmark
Contacts
Primary ContactNina Timmerby, MD
Outcome results
None listed