A Precision Medicine Approach to the Prevention of Depression in Patients With Atrial Fibrillation - HOPE-AF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Drop out rate
研究概览
简要总结
The purpose of the proposed project is to test a new therapist-assisted, eHealth intervention (HOPE-AF) targeted to prevent depression in patients with atrial fibrillation (AF). AF is the most common sustained cardiac arrhythmia. Age is the most common risk factor for AF, and given the ageing of the population, the prevalence of AF has increased threefold during the last 50 years. AF is now considered a major public health challenge. AF is not only associated with increased risk of stroke and heart failure but patients with AF also tend to continuously focus on the body's signals and have difficulties accepting the disease. This is often paired with psychological reactions, such as excessive worry and anxiety, increasing the risk of withdrawal from social activities, which often leads to depression. Patients with AF and comorbid depression are at greater risk of a poor prognosis.
The project is a feasibility study to examine acceptability, adherence and limited efficacy, as well as barriers and facilitators for implementation of the intervention in clinical practice. The project is multi-disciplinary and embedded within the rehabilitation setting in the hospitals, enhancing the chance of later implementation.
详细描述
HOPE-AF represents a novel and pioneering approach to improving the HRQoL and prognosis of patients with AF through the prevention of depression, a seminal and debilitating risk factor for the onset of AF and worsening AF prognosis. Together with patients, the investigators co-designed an online psychological intervention that targets risk factors for depression with respect to preventing depression.
The feasibility of the intervention in clinical practice will be assessed. The intervention will be delivered via a GDPR-secured platform. This is an innovative solution for care delivery, enabling patients to access the intervention anytime, which may enhance adherence due to the flexibility of access and delivery. The investigators has previously shown that this eHealth mode of delivery is well received by patients.
Meta-analyses show that online psychological interventions are effective in preventing depression and anxiety in both at-risk cohorts and the general population. These positive effects have been shown for the cognitive-behavioral, interpersonal, and positive psychology therapeutic approaches.
The HOPE-AF intervention Recent research demonstrates that personalizing the prevention of depression by targeting individual risk factors for the disorder in every single patient can optimize treatment outcomes. HOPE-AF will specifically target and remediate the core risk factors for depression of each enrolled individual patient (i.e., stress, loneliness, social isolation, anhedonia, lack of exercise, low self-esteem, rumination, anxiety and sleep problems), using existing evidence-based treatments and a precision medicine approach to prevent depression.
The intervention is co-developed with patients and health professional and targeted to AF patients without current depression and anxiety. The intervention modules consist of psychoeducation, psychological tools, psychological therapies targeted to patients' risk factors for depression, and multimedia contents and exercises. Patients will complete the modules online and be assisted by a therapist who will provide feedback through asynchronous text messages via a GDPR secured platform. Phone or video (according to patients´ preferences) consultations with the therapist as add-on to the online intervention will be possible on a need to basis. The treatment duration will vary from patient to patient depending on the prevalent risk factors for depression and the severity of the risk factors. The duration will range from 4-12 weeks, as some modules will be mandatory for all patients, while other modules will only be relevant to target specific risk factors. Patients are expected to spend 1-2 hours per week on a module.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Age ≥18 years
- •Diagnosis of paroxysmal or persistent AF [if persistent AF, duration < 2 years]
- •Able to use and access a computer or tablet/iPad to adhere to the intervention - Proficient in the Danish language (reading and writing)
- •Ability to provide informed written consent.
排除标准
- •Depression [Hospital Anxiety and Depression Scale: HADS-D ≥11 (moderate symptoms)
- •Anxiety [Hospital Anxiety and Depression Scale: HADS-A ≥11 (moderate symptoms)
- •Severe psychiatric or neurological disorder (e.g., schizophrenia or dementia)
- •In need of psychiatric help due to comprehensive psychiatric issues, diagnosed or not
- •Seeing a psychologist or mental health professional for the treatment of depression and anxiety
- •Experiencing significant life stressors that hinder adherence to the HOPE-AF treatment
- •Participating in another research project involving intervention for depression
- •Not being able or willing to spend 1-2 hours on the intervention each week
研究组 & 干预措施
online psychological intervention
The participants will receive the HOPE-AF online psychological intervention. The intervention is designed to prevent depression in patients with atrial fibrillation
干预措施: Online psychological intervention (Other)
结局指标
主要结局
Drop out rate
时间窗: From start of the intervention to completion of intervention, i.e., from 0 to 12 weeks.
Drop out rate. What is the rate of drop out during the intervention from the 28 included patients. Drop out is defined as patients who want to stop the intervention or patients who stop responding to messages and phone/video calls. A drop-out rate \<25% was considered acceptable.
次要结局
- Adherence(From start of the intervention to completion of intervention, i.e., from 0 to 12 weeks.)
- Symptoms of depression(From completion of baseline questionnaire (after enrollment and prior to intervention start) to completion of follow up questionniare (sent to patients 13 weeks after intervention start).)
- Anxiety related to cardiac disease(From completion of baseline questionnaire (after enrollment and prior to intervention start) to completion of follow up questionniare (sent to patients 13 weeks after intervention start).)
- Symptoms of anxiety(From completion of baseline questionnaire (after enrollment and prior to intervention start) to completion of follow up questionniare (sent to patients 13 weeks after intervention start).)
- Atrial fibrillation related quality of life(From completion of baseline questionnaire (after enrollment and prior to intervention start) to completion of follow up questionniare (sent to patients 13 weeks after intervention start).)
- AF symptom burden(From completion of baseline questionnaire (after enrollment and prior to intervention start) to completion of follow up questionniare (sent to patients 13 weeks after intervention start).)
- Health related Quality of Life(From completion of baseline questionnaire (after enrollment and prior to intervention start) to completion of follow up questionniare (sent to patients 13 weeks after intervention start).)