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| Name | Class |
|---|---|
| Mental Health Centre North Zealand | UNKNOWN |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family psychoeducation | Behavioral |
| ||
| Social support group |
| 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 |
| 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 |
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Patients:
Inclusion Criteria:
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:
Regarding to the relatives following criteria for participation apply:
Inclusion criteria:
• Age between 18 and 75
Exclusion criteria:
• Insufficient knowledge of Danish
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nina Timmerby, MD | Contact | +4538643197 | nina.02.timmerby@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Nina Timmerby Timmerby, MD | Mental Health Centre North Zealand, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Research Unit, Mental Health Centre North Zealand | Recruiting | Hilleroed | 3400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27577267 | Derived | 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. |
| Label | URL |
|---|---|
| For information about the project (in Danish) | View source |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012657 | Self-Help Groups |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| Behavioral |
|
Reduction of depressive symptoms in the HAM-D6-score (hypothesis 3).
| 9 months |