Regional Study of Internet-based Relapse Prevention as an Adjunct to Partially Successful Antidepressant Medication
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 264
- 试验地点
- 4
- 主要终点
- Days absent from work due to sick leave
研究概览
简要总结
The main purpose of the study is to test whether Internet-based relapse prevention plus medication has a better protective effect compared to medication only, for persons with residual depressive symptoms who are currently in paid employment or in education. We hypothesise that during the two years following the intervention:
- The persons in the group receiving Internet-based relapse prevention plus medication will be absent from work for fewer days due to sick-leave compared to those in the medication-only group.
- Fewer persons in the group receiving Internet-based relapse prevention + medication will experience long term sick-leave (60 days or more) compared to those in the medication-only group.
- The persons in the group receiving Internet-based relapse prevention plus medication will suffer fewer depressive relapses compared to those in the medication-only group.
- At follow-up, the persons in the group receiving Internet-based relapse prevention plus medication will have higher health related quality of life and lower levels of depressive symptoms compared to those in the medication-only group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild residual depressive symptoms (7-19 on the MADRS-S).
- •A history of at least one episode of Major Depression.
- •Currently in (at least) half-time employment, self-employment or education.
- •Taking a stable (since one month) and therapeutic dosage of antidepressant medication
- •Being able to read and write Swedish
- •Having access to the internet
排除标准
- •Fulfilling the criteria for Major depression
- •Psychosis
- •Substance abuse
- •Suicidality
结局指标
主要结局
Days absent from work due to sick leave
时间窗: 24 month follow up
The total number of days that a participant has been absent from work due to sick leave (any cause). Data will be collected from the National Insurance Agency at the end of the study.
Change in self-reported sick leave days
时间窗: After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months
Self-reported number of sick leave days during the study will be collected cumulatively every month during the study time and summarised after 24 months.
Change in diagnostic status
时间窗: After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months
Change in diagnostic status (depressive relapse) will be assessed in a telephone interview every month during the study. The definition of a relapse is to fulfill the diagnostic criteria for major depression according to the DSM-IV at any time after the study start.
Change in depressive symptoms
时间窗: After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated. The patient will fill out the questionnaire every month.
次要结局
- Change in health related quality of life(After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months)
- Change in costs associated with illness(Pre- and post treatment, after 12 and 24 months)
研究者
Fredrik Holländare
Clinical Psychologist, PhD
Örebro County Council