Clinical trial NCT02348827: Family Psychoeducation for Major Depressive Disorder
Official title: Family Psychoeducation for Major Depressive Disorder - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Unipolar depression
Family Therapies
Psychoeducation
Family psychoeducation
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Mental Health Centre North Zealand
First posted: 2015-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of relpase
timeFrame: 9 months
Secondary outcomes:
measure: Time to relapse
timeFrame: Up to 9 months from baseline
measure: Reduction of depressive symptoms
timeFrame: 9 months
Other outcomes:
Locations:
city: Hilleroed
country: Denmark
facility: Psychiatric Research Unit, Mental Health Centre North Zealand
Study officials:
affiliation: Mental Health Centre North Zealand, Denmark
name: Nina Timmerby Timmerby, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.