Uppsala University Psychosocial Care Programme: Internet Based Screening and Stepped Care for Adult Cancer Patients With Anxiety and Depression Symptoms - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 229
- 试验地点
- 6
- 主要终点
- Change in depression
研究概览
简要总结
The aim is to evaluate the effects of Internet based Stepped Care on anxiety, depression and health related quality of life in cancer patients with anxiety and depression symptoms, compared to Standard Care, and to evaluate the health-economic effects of the intervention. The investigators also want to examine the development of anxiety and depression symptoms and health related quality of life in cancer patients without initial symptoms.
The primary hypothesis is that Internet based Stepped Care (I-SC) is more effective in relieving anxiety and depression symptoms in cancer patients, compared to Standard Care (SC). Secondary hypotheses are that less anxiety and depression symptoms also means improved health related quality of life and that I SC is cost-effective or at least cost neutral compared to standard care.
The IT-platform Carebase.se is developed within U-CARE. The platform will be used for delivering of interventions and for collection of all patient reported outcomes. Patients with anxiety or depression symptoms according to the Hospital Anxiety and Depression Scale will be randomized to I SC or SC. Patients with no initial anxiety or depression symptoms will be included in descriptive studies. All patients, in the randomized controlled trial and the descriptive study will followed up during 24 months
I-SC comprises interactive support (Step 1) and Cognitive Behavioral Therapy (CBT; Step 2). Step 1 starts directly after randomization and extends over a 24 months period. Step one comprises web-based patient education including psycho-education and easy interventions strategies employed in CBT. Step 1 also includes a FAQ, a discussion board for patients and a personal diary. Project staff (nurses) is responsible for the FAQ and to moderate the discussion board. The nurses will be supervised by a CBT psychologist. They can also turn to other experts in the project group for advices about how to answer patients' questions.
Patients with remaining anxiety or depression symptoms at 1, 4 or 7 months after randomization will be offered Step 2. Step 2 comprise conventional Internet based CBT for common psychological concerns. The participants' chooses to work with modules that correspond to prioritized concerns, e.g. anxiety or depression. The CBT is structured and manualized and include conventional treatment methods with homework and weekly contacts with the psychologist. Step 2 extends over a 10-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Newly diagnosed Breast- Colorectal- or Prostate cancer or recurrent Colorectal cancer within 3 months form diagnoses
排除标准
- •inability to communicate in Swedish
- •Karnovsky performance status < 40
- •short expected survival (< 6 month)
- •cognitive disability (e.g. dementia or psychosis)
- •severe depression or suicide risk
结局指标
主要结局
Change in depression
时间窗: From baseline and 10 months later (after intervention)
Hospital Anxiety and Depression Scale (HADS) - depression subscale. Range 0-21, \>7 is defined as doubtful cases and \>10 is defined as clinical cases. Montgomery Åsberg Depression Rating Scale (MADRS). Range 0-60 points, \>30 is defined as severe depression, \>3 at question nr. 9 is defined as suicide risk.
Change in anxiety
时间窗: From baseline and 10 months later (after intervention)
Hospital Anxiety and Depression Scale (HADS) - anxiety subscale. Range 0-21, \>7 is defined as doubtful cases and \>10 is defined as clinical cases. Spielberger State-Trait Anxiety Inventory State subscale (STAI-S). Range 20-80.
次要结局
- Change in insomnia(From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention))
- Change in health related quality of life(From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention))
- Change in Cancer related fatigue (CRF)(From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention))
- Change in posttraumatic stress(From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention))