The New Internet Generation: iCBT Treatment for Seniors With Mild-moderate Depression - a Pragmatic Randomised Controlled Trial in the Primary Care Context
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- MADRS-S (Montgomery and Asberg Depression Rating Scale)
研究概览
简要总结
This clinical trial aims to evaluate the potential benefits of internet cognitive behavioural therapy (iCBT) for elderly patients with mild/moderate depression and compare its effectiveness with the current treatment as usual (TAU) at primary care centres (PCCs).
The specific aims are to study if:
iCBT is as effective as TAU in reducing depressive symptoms iCBT is as effective as TAU in increasing quality of life iCBT is as effective as TAU in increasing the function in patients >65 years and older with mild/moderate depression attending primary care, with the perspective of 36 months.
Participants will:
Work with the iCBT program (10-12 weeks) or become TAU at their PCCs. Followed-up at 3, 6, 12, 24 and 36 months of their symptoms, quality of life and function.
详细描述
Study Objective:
The primary aim is to determine if iCBT is as effective for treating mild-moderate depression in older adults (<65) as it is for younger age groups. The study will assess various outcomes throughout 3, 6, 12, 24, and 36 months, including depressive symptoms, quality of life, workability, relationships, activities of daily living, and social participation.
Trial Design:
It's a randomised controlled trial (RCT) with two groups: intervention (iCBT) and control (TAU). The pragmatic design closely resembles real-world primary care conditions to ensure the results apply to routine clinical practice.
Population:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients >65, attending PCCs engaged in the trial, with mood as well as somatic complaints will be asked about depressive symptoms during the last 2 weeks by NICE guidelines for depression.
- •All patients diagnosed with minor/major depression and not belonging to
排除标准
- •and willing to take part in the trial will be diagnosed via the Mini International Neuropsychiatric Interview (M.I.N.I.) by a psychologist/specially trained nurse and have a General Practitioner (GP) somatic consultation
- •Exclusion Criteria:
- •Patients diagnosed with:
- •severe depression
- •prior suicide attempt or currently at medium to high risk of suicide (MADRS-S question 9>3 points or MINI suicide >9)
- •bipolar disorder
- •psychosis
- •addiction
- •cognitive impairment
- •not speaking or understanding Swedish.
结局指标
主要结局
MADRS-S (Montgomery and Asberg Depression Rating Scale)
时间窗: Change from baseline scores MADRS-S scale at 36 months
What is the effect of iCBT on participants' symptoms of depression (measured as a change in score in MADRS-S from baseline to 36 months after baseline)? Scale: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression
次要结局
- The 5-level EQ-5D version (EQ-5D-5L) EuroQol 5-Dimension(Change from baseline scores EQ-5D scale at 3 months)
- WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered(Change from base-line scores WHODAS scale at 36 months)
- The 5-level EQ-5D version (EQ-5D-5L)(Change from baseline scores EQ-5D scale at 36 months)
- Work ability(Change from base-line scores WAI scale at 36 months)
- General Self-Efficacy Scale (GSE)(Change from base-line scores GSE scale at 36 months)
- The Health Literacy Survey European Questionnaire (HLS-EU-Q16)(Change from base-line scores HLSE-EU-Q16 scale at 36 months)
- Use of Antidepressants(Antidepressant use will be assessed at baseline and after 12 months of participation in the study.)