Internet-delivered Mindfulness-Based Cognitive Therapy for Symptoms of Depression, Anxiety, and Stress Among Women Treated for Breast Cancer and Men Treated for Prostate Cancer - Effects and Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Symptoms of Anxiety
研究概览
简要总结
AIM: The aim of the present study is to investigate if Internet-delivered Mindfulness-Based Cognitive Therapy (I-MBCT) can reduce symptoms of depression and anxiety among women treated for breast cancer and men treated for prostate cancer compared to a treatment as usual control group. Furthermore, the effect of I-MBCT on symptoms of stress, insomnia, quality of life, and self-compassion and the potential mediating effect of working alliance and mindfulness will be explored. Finally, the cost-effectiveness of the I-MBCT intervention will be explored.
BACKGROUND: Symptoms of depression, anxiety, and stress are prevalent late-effects among cancer patients and -survivors. Mindfulness-based interventions aim at improving affect tolerance and emotion regulation, which could be of particular relevance for cancer patients and survivors, and MBCT has been shown efficacious in treating symptoms of depression, anxiety, and stress among cancer patients and survivors. However, the availability of face-to-face delivered MBCT is limited and hence using the internet to deliver MBCT may be a cost-effective way of increasing the accessibility of the intervention to vulnerable patients with limited resources.
METHODS: A total of 155 participants will be recruited from Department of Oncology and Department of Urology at Aarhus University Hospital and randomized to two groups: I-MBCT and a treatment-as-usual wait-list control group. Assessments will be conducted at pre-, midway and post intervention and at a 6- months follow-up.
详细描述
BACKGROUND
Symptoms of depression, anxiety, and stress is common among both cancer patients and cancer survivors and can lead to prolonged hospitalization, reduced quality of life, and deteriorate prognosis. In Mindfulness-Based Cognitive Therapy (MBCT) participants practice attention towards the present moment and acceptance of feelings and physical discomfort. This is in particular relevant for cancer patients and -survivors who often experience psychological symptoms connected to negative thoughts about the past and worries about the future.
MBCT is an 8-week group intervention and has shown to be effective in treating psychological distress in cancer survivors. Many cancer survivors experience challenges in following a group intervention because of health related reduced mobility and work- and family schedule conflicts, and hence it is relevant to investigate an internet-delivered alternative to MBCT.
I-MBCT is a manualized treatment for breast- and prostate cancer survivors, based on the manual for Mindfulness-Based Cognitive Therapy for depression. I-MBCT consist of 8 weeks of mindfulness practice combined with reading theory and supported by weekly text messages and answers from a therapist.
AIMS AND HYPOTHESES
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessors performing introduction calls are masked in the sense that participants will not be randomized until after the introduction call. All questionnaires are completed as online surveys and are hence masked for group allocation.
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
- •Man treated for prostate cancer or woman treated for breast cancer
- •Active cancer treatment must have been completed (radiation therapy, operation and chemotherapy) within the past 5 years. Ongoing endocrine therapy is all right.
- •A minimum score of 3 on anxiety and/or depression items from Symptom Check-List-8, subscale in Common Mental Disorder Questionnaire (SCL-8, CMDQ).
- •Internet access on a daily basis
- •Must have a cell phone
排除标准
- •Cancer recurrence or ongoing cancer treatment.
- •Problems with reading and/or understanding Danish
- •Insufficient IT skills
- •Severe mental illness causing problems with following the internet-delivered treatment, e.g. dementia, known psychotic disorder or developmental disorder.
研究组 & 干预措施
Internet-delivered MBCT
The intervention group will immediately receive 8 weeks of therapist-assisted internet-delivered Mindfulness-Based Cognitive Therapy.
干预措施: Internet-delivered Mindfulness-Based Cognitive Therapy (Behavioral)
Waitlist control
The control group will be on a waiting list to participate in Internet-delivered MBCT after the 6-months follow-up time has passed.
干预措施: Waitlist control (Behavioral)
结局指标
主要结局
Symptoms of Anxiety
时间窗: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
Change in symptoms of anxiety assessed by State-Trait Anxiety Inventory Form Y (STAI-S)
Symptoms of Depression
时间窗: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
Change in symptoms of depression assessed by Beck Depression Inventory II (BDI-II)
次要结局
- Cost-Effectiveness(Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment)
- Symptoms of Stress(Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment)