Family Psychoeducation for Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Family Psychoeducation for Major Depressive Disorder - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02348827
• Other study ID #: H-4-2014-044
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2015
• Last updated: April 27, 2016
• Start date: January 2015
• Est. completion date: September 2017

Study information

• Verified date: April 2016
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Nina Timmerby, MD
• Phone: +4538643197
• Email: nina.02.timmerby[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Family psychoeducation

• Social support group

Locations

Country	Name	City	State
Denmark	Psychiatric Research Unit, Mental Health Centre North Zealand	Hilleroed

Sponsors (2)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Mental Health Centre North Zealand

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Reduction of depressive symptoms	Reduction of depressive symptoms in the HAM-D6-score (hypothesis 3).	9 months	No

External Links

•   For information about the project (in Danish)