Effects of Cognitive Behavior Therapy on Anxiety, Depression, Illness Perception, and Quality of Life in Paroxysmal Atrial Fibrillation Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change from baseline score of The 12-item Health Survey Short Form (SF-12) at 10 weeks and 6 months
研究概览
简要总结
Health-Related Quality of Life (HRQoL) was commonly impaired in atrial fibrillation patients. Depression, anxiety, and illness perception are psychological correlates of HRQoL. Our previous study had shown good effects of CBT on the quality of life in AF patients. This study aimed to establish the long-term efficacy of CBT on both psychological distress and HRQoL. Method: The study was a prospective, open study, pseudo-randomization with a pretest-posttest design and a 6-month follow-up. A total of 102 patients with paroxysmal AF were enrolled, and 90 patients were assigned (1:1) to 10 weeks of CBT focused on anxiety symptoms or to treat as usual in the end. Item Short Form Health Survey (SF-12), GAD-7, PHQ-9, University of Toronto Atrial Fibrillation (AFSS), and Brief Illness Perception Questionnaire (BIPQ) were measured as outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for participation were: (a) age 18-75 years; (b) AF diagnosis, based on a 12-lead ECG and cardiologist-led examination following the 2016 ESC Guidelines for the Management of Atrial Fibrillation5 and (c) paroxysmal AF diagnosis given by a cardiologist according to the conversion back to the normal sinus rhythm occurs spontaneously within a week
- •(d) ability to read and write in Chinese.
排除标准
- •(a) severe complications such as unstable coronary artery disease, heart failure with severe systolic dysfunction(ejection fraction≤35%); (b)AF soon after thoracic surgery; (c) malignant disease with a 1-year survival rate or a terminal illness diagnosis; (d) a diagnosed psychiatric condition that interfered with participation (including severe depression, bipolar disorder, psychotic illness of any type, dementia, acute suicidality, severe personality disorder);(e) regular psychological therapy with a mental health condition; (f) participation in another study; (g) cognitive impairment interfering with their ability to participate in the study.
结局指标
主要结局
Change from baseline score of The 12-item Health Survey Short Form (SF-12) at 10 weeks and 6 months
时间窗: Both groups were assessed the SF-12 three times, respectively at baseline, 10 weeks later and 6 month later
SF-12 is a 12-item, multipurpose short-form survey that is used to measure generic HRQoL (derived from the SF-36). The findings are weighted and summed to produce interpretable scales for a participant's physical and mental well-being. SF-12 is divided into two domains: the physical component summary (PCS) and the mental component summary (MCS). Each domain scores from 0 to 100, with higher scores indicating a better health status
次要结局
- Brief Illness Perception Questionnaire (BIPQ)(Both groups were assessed the BIPQ three times, respectively at baseline, 10 weeks later and 6 month later)
- University of Toronto Atrial Fibrillation Severity Scale (AFSS)(Both groups were assessed the AFSS symptoms subscale three times, respectively at baseline, 10 weeks later and 6 month later)
- The Patient Health Questionnaire-9 (PHQ-9)(Both groups were assessed the PHQ-9 three times, respectively at baseline, 10 weeks later and 6 month later)
- The Generalized Anxiety Disorder Questionnaire (GAD-7)(Both groups were assessed the GAD-7 three times, respectively at baseline, 10 weeks later and 6 month later)
研究者
Qu Shan
Head of the Department of Medical Psychology
Peking University People's Hospital