Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-01-31
2017-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Family psychoeducation
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.
Social support group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Family psychoeducation
Social support group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
• Age between 18 and 75
Exclusion Criteria
* 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:
• Insufficient knowledge of Danish
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mental Health Centre North Zealand
UNKNOWN
Mental Health Services in the Capital Region, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nina Timmerby Timmerby, MD
Role: PRINCIPAL_INVESTIGATOR
Mental Health Centre North Zealand, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Psychiatric Research Unit, Mental Health Centre North Zealand
Hilleroed, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Nina Timmerby, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
For information about the project (in Danish)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-4-2014-044
Identifier Type: -
Identifier Source: org_study_id