Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD) - Screen-ICD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Primary outcome is anxiety measured by HADS.
研究概览
简要总结
The hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention.
The aim of this randomised trial is (I) to determine the type of anxiety in ICD patients and (ii) to investigate the effect of screening followed by randomisation to intervention with consultations based on cognitive therapeutic principals to reduce anxiety in patients with ICD or usual care.
详细描述
Screen-ICD is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, including two university hospitals, with 1:1 randomisation to cognitive therapy plus usual care or usual care alone.
The intervention: all patients receive usual care. Patients in the intervention group will receive an intervention based on cognitive behavioral therapy. The intervention consists of three steps: 1. The intervention begins with a consultation with a nurse aiming at uncovering anxiety using the Hamilton anxiety scale and exploring how life with an ICD is perceived, 2. Based on the pre-specified protocols for each type of anxiety, cognitive therapy is provided and 3. After each session participants are asked to fill out the HADS questionnaire. When the patient scores below the cut-off value two times in a row, sessions will end. Each patient can have a maximum of 15 sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Over 18 years
- •Have had ICD implantation
- •Speaks and understands Danish
- •Scores 8 or more in the HADS-A questionnaire
- •Gives written informed consent
排除标准
- •Scores 11 or more in the HADS-D questionnaire and the depression score exceeds the anxiety score.
研究组 & 干预措施
Cognitive therapy
The intervention consists of 3 steps. 1: Consultation with a nurse that aims of identifying what the anxiety consist of and how the patient experiences his or her life situation with an ICD. A plan is made to structure the treatment. 2: Participation in an individualized intervention based on anxiety type specific protocols. 3. The intervention is considered finalized if the patient has a HADS-A score under 8 two times in a row. The intervention group will receive usual care as well.
干预措施: Cognitive Therapy (Behavioral)
Usual care
The control group will receive usual care which consists of control of ICD, disease control and treatment, and at one of the sites an offer of a group information meeting where experiences and events with ICD are discussed. The meeting takes place at Rigshospitalet every other month.
结局指标
主要结局
Primary outcome is anxiety measured by HADS.
时间窗: 16 weeks
HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards. Scores of 0 to 7 for either subscale are regarded as normal and scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 and above suggest probable presence of a mood disorder.
次要结局
- Becks Anxiety Inventory (BAI)(16 weeks and 12 months)
- HeartQoL(16 weeks and 12 months)
- Anxiety measured by HADS.(12 months)
- Hamilton Anxiety Scale (HAM-A)(16 weeks and 12 months)
研究者
Selina Kikkenborg Berg
Senior reseacher
Rigshospitalet, Denmark