Family Psychoeducation for Major Depressive Disorder

Family Psychoeducation for Major Depressive Disorder - a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Family psychoeducation; Behavioral: Social support group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nina Timmerby, MD; Phone Number: +4538643197; Email: nina.02.timmerby@regionh.dk

Study Locations

• Denmark
  • Hilleroed, Denmark, 3400
    • Recruiting
    • Psychiatric Research Unit, Mental Health Centre North Zealand
    • Contact: Nina Timmerby, MD; Phone Number: +4538643197; Email: nina.02.timmerby@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family psychoeducation; 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
Active Comparator: Social support group; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: Mental Health Centre North Zealand
• Investigators: Principal Investigator: Nina Timmerby Timmerby, MD, Mental Health Centre North Zealand, Denmark

Publications and helpful links

General Publications

• 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.

Helpful Links

• For information about the project (in Danish)

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: January 5, 2015
• First Submitted That Met QC Criteria: January 22, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Estimate): April 29, 2016
• Last Update Submitted That Met QC Criteria: April 27, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Psychoeducation; Family psychoeducation; Unipolar depression; Family Therapies
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: H-4-2014-044