Online Personalized and Patient-preferred Comprehensive Intervention for Patients With Heart Disease and Depression or Anxiety (MY-CHOICE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Drop-out rate
研究概览
简要总结
The goal of this feasibility study is to assess if the personalised online psychological intervention MY-CHOICE is acceptable to adults with ischemic heart disease and anxiety or depression. It will also examine the reasons for drop-out. The main questions the study aims to answer are:
How many participants complete the intervention and what are the reasons for drop-out. And what are the pre-post change scores on anxiety and depression.
Participants will:
Complete the MY-CHOICE intervention consisting of 6-12 weeks with online modules on various topics based on individual needs in combination with video- or telephone calls with a therapist (psychologist or a trained master student in Psychology) on a need-to basis.
Answer a set of questionnaires pre and post intervention. Participate in a brief interview post intervention.
详细描述
The MY-CHOICE project will assess the feasibility of a therapist-assisted eHealth intervention on patient satisfaction and dropout (barriers and facilitators), quality of life, and procedures with respect to recruitment and implementation in the CR settings. It is hypothesized that a therapist-assisted eHealth intervention that is personalized to patients' needs and preferences and that allows patients to engage in the intervention when and where they want, may reduce patients' barriers for seeking and engaging in treatment (e.g. drop-out).
Study design The MY-CHOICE intervention is a new comprehensive eHealth program for patients with IHD based on the premise of personalized medicine.
The intervention targets depression, anxiety and other common challenges met by patients with IHD attending CR that have been shown to impact on patients' quality of life, prognosis, motivation for self-care, compliance, and risk factor management.
Using a pre- post-test design, the study will examine the feasibility of (i) the intervention in 30 patients with IHD and co-morbid depression and/or anxiety referred to CR at one of the participating sites, including asking patients about the reason for drop-out at the time of drop-out, and (ii) evaluate the procedures for recruitment at the participating CR sites with respect to conducting a potential RCT and future implementation in routine care. Post intervention, investigators will ask all patients and 3-6 members of the CR team to complete a set of questions online related to identify barriers and facilitators for implementing the intervention in clinical care at a patient and organizational level.
Study population Patients will be recruited from cardiac rehabilitation centers in Denmark.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •ischemic heart disease (diagnostic codes I20-I25),
- •referred for CR with a positive screen for depression and/or anxiety with the Hospital Anxiety and Depression Scale (HADS ≥ 8)
- •access to and ability to use a computer or tablet
- •proficient in the Danish language
排除标准
- •Severe psychiatric disorder (i.e., borderline disorder, schizophrenia or bipolar disorder) that requires psychiatric care
- •severe cognitive difficulties (e.g., severe brain damage, mental retardation, or dementia) that will prevent patients from participating
- •endorsement of suicidal ideation with suicidal thoughts (purpose designed questions) that cannot be handled in the intervention
- •participation in other intervention studies focused (unless they are clinical studies)
- •seeing a psychologist or mental health professional for the treatment of anxiety and depression
- •not being able or willing to spend 3-4 hours on the intervention each week
- •experiencing significant life stressors that hinder adherence to the MY-CHOICE treatment
研究组 & 干预措施
Psychological intervention
Online psychological intervention for anxiety and depression, tailored to the patients´ individual needs. Duration 6-12 weeks.
The psychological intervention is provided as add-on to treatment as usual (i.e., the patients´ individual medical treatment and rehabilitation program.)
干预措施: Online psychological therapy (Other)
结局指标
主要结局
Drop-out rate
时间窗: From enrollment to end of treatment i.e., from 0 to 13 weeks
次要结局
- Limited efficacy on depression (HADS-D)(From baseline to completion of 3-month follow-up which is administered after 13 weeks.)
- Limited efficacy Anxiety (HADS-A)(From completion of baseline questionnaire to completion of post intervention questionnaire administered 13 weeks after enrollment.)
- Patient satisfaction with intervention(Administered in the FU-questionnaire 13 weeks after enrollment)
- adherence to intervention(immediately after completion of intervention. i.e. between 6 and 12 weeks depending on the length of intervention. Possibly sooner if a patient drops out.)
- Limited efficacy on stress(Administered in the FU-questionnaire 13 weeks after enrollment)
- Limited efficacy on quality of life(Administered in the FU-questionnaire 13 weeks after enrollment)