A Controlled Trial of Smartphone-delivered Cognitive Behavioral Therapy for Adults Treated With Medication for Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Montgomery Asberg Depression Ranging Scale (MADRS)
研究概览
简要总结
The purpose of the study is to investigate if a smartphone app combined with internet delivered cognitive behavioural therapy (ICBT) leads to improved symptoms in depressive adults on antidepressive mediation. The participants in the treatment group will get access to a smartphone app based on CBT-principles for 9 weeks. They will also get access to an internet platform with extra treatment material based on CBT and receive therapist support on demand. Participants will be recruited in Sweden with nationwide recruitment.
详细描述
This study is a randomized controlled trial with the aim to investigate if an smartphone app in combination with ICBT can help adults (+18) on antidepressant medication who still suffers from depressive symptoms. Participants will either be randomized to a treatment phase for 9 weeks or to a wait-list control. The treatment primarily contains the installation and usage of a smartphone app where the participants can engage in a serious mobile game based on CBT-principles. They will receive access to a secure internet platform where they can find general guidelines about the app, and extra treatment modules (to use if needed). They will receive support on demand from a therapist during the whole treatment period.
Primary outcome measure is depressive symptoms (measured on the MADRAS scale). Secondary outcome measures will include measures of anxiety and quality of life. Pre-treatment measurement, post-treatment measurement, weekly measure, and 24 & 36 months follow up is planned to be collected through an online survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Ongoing drug treatment with an antidepressant mediated by an established care contact in (primary) care.
- •18 years or older.
- •Be able to speak, read and write Swedish.
- •Have access to a computer, tablet or other device with internet connection and smartphone to download the app.
排除标准
- •Severe psychiatric or somatic problems that make participation difficult or impossible
- •Ongoing abuse (via Audit and during interview)
- •Acute suicidality
- •Other ongoing psychological treatment or planned investigation.
- •Planned dose change of medicine or change of medicine during pre-measurement.
结局指标
主要结局
Montgomery Asberg Depression Ranging Scale (MADRS)
时间窗: From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.
MADRS-S is a questionnaire including nine questions about depressive mental states. The questions aslo address experienced worry, ability to concentrate and initiative. Each question gives between 0 and 6 points. Maximum score is 54 points. Higher scores indicate higher levels of depression.
次要结局
- Generalized Anxiety Disorder-7(From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.)
- Brunnsviken Brief Quality of life scale(From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.)
研究者
Gerhard Andersson
PhD, Professor
Linkoeping University