Family Psychoeducation for Major Depressive Disorder - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of relpase
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Number of relpase
时间窗: 9 months
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.
次要结局
- Reduction of depressive symptoms(9 months)
- Time to relapse(Up to 9 months from baseline)