(Cost-) Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) in Cancer Patients: a Superiority Trial of Online and Face-to-face Treatment Versus Treatment as Usual (TAU).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 4
- 主要终点
- Change from baseline in anxiety and depressive symptoms
研究概览
简要总结
Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing anxiety, depression and fatigue in cancer patients. As this intervention can be offered in groups, costs are relatively low. In addition, delivering MBCT online might make the intervention more accessible and cost-effectiveness. However, more information is needed about what treatment works best for which patient.
Therefore, the aim of this study is to investigate clinical and cost-effectiveness of both individual MBCT online and MBCT offered as a group training compared to TAU .
Study design: The design of the study will be a multi-centre, randomised, superiority trial, comparing MBCT online and MBCT offered as a group training with TAU. Participants in the TAU condition will be randomised to one of the treatment conditions after 3 months. Main assessments will take place at baseline (T0), post-treatment (T1), and 3 (T2) and 9 months after post-treatment (T3).
We expect the MBCT conditions to be superior to TAU in terms of improving mindfulness skills, anxiety and depressive compants, psychological well-being, rumination and fear of cancer recurrence. We also expect the MBCT to result in patients returning to work earlier, have a higher work ability and have lower medical care costs, thereby being more cost-effective than TAU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •HADS ≥ 11
- •Cancer diagnosis (at present or past)
- •Stable dose if using psychopharmacological medication for at least 3 months
- •computer literacy and acces to internet
- •capable of filling out questionnaires in Dutch
排除标准
- •severe psychiatric morbidity as psychoses, suicidal ideation
- •previous mindfulness-based treatment.
结局指标
主要结局
Change from baseline in anxiety and depressive symptoms
时间窗: 0 (baseline), 3 months (post intervention)
Anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression-scale (HADS). The HADS is a self-report questionnaire that comprises 14 items measuring feelings of generalized fear and depressive symptoms. The HADS is considered a reliable and valid instrument for assessing anxiety and depression in medical patients and is sensitive to change (Herrmann, 1997; Bjelland et al., 2002). This instrument was also validated in a palliative cancer population (Akechi, 2006).
次要结局
- Change from baseline in fear of cancer recurrence(0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up))
- Change from baseline in mindfulness skills(0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up))
- DSM-IV Axis I mood or anxiety disorders(0, 3 (post intervention), 12 months (9mo follow-up))
- Change from baseline in personality assessment(0 (baseline) and 12 months (9mo follow-up))
- Working alliance during intervention(week 4 and week 9 during intervention)
- Change from baseline in healthcare consumption(0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up))
- Change from baseline in rumination(0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up))
- Group cohesion during intervention(week 4 and week 9 during intervention)
- Change from baseline in positive mental health(0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up))
- Change in mindfulness skills during intervention(week 2,3,4,5,6,7,8 and 9 of intervention)
- Change in mood during intervention(week 2,3,4,5,6,7,8 and 9 of intervention)
- Change from baseline in anxiety and depressive symptoms - follow up(0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up))
- Change from baseline in health-related quality of life(0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up))