Family Psychoeducation for Major Depressive Disorder
Family Psychoeducation for Major Depressive Disorder - a Randomized Controlled Trial
研究概览
详细说明
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:
- 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
- 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
- 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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Hilleroed、丹麦、3400
- 招聘中
- Psychiatric Research Unit, Mental Health Centre North Zealand
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接触:
- Nina Timmerby, MD
- 电话号码:+4538643197
- 邮箱:nina.02.timmerby@regionh.dk
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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.
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有源比较器: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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of relpase
大体时间:9 months
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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.
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9 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Time to relapse
大体时间:Up to 9 months from baseline
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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)
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Up to 9 months from baseline
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Reduction of depressive symptoms
大体时间:9 months
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Reduction of depressive symptoms in the HAM-D6-score (hypothesis 3).
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9 months
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合作者和调查者
调查人员
- 首席研究员:Nina Timmerby Timmerby, MD、Mental Health Centre North Zealand, Denmark
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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