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临床试验/NCT05081947
NCT05081947已完成不适用

Assessing the Acceptability and Feasibility of COMPASS, a Transdiagnostic Web-based Intervention for the Management of Depression and Anxiety in Long-term Conditions, in Community-based Heart Failure Patients

King's College London1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2021年11月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
1
主要终点
Treatment usability using the System Usability Scale (SUS)

研究概览

简要总结

Heart failure (HF) is a complex clinical syndrome characterized by the inability of the heart to pump an adequate amount of blood. Heart failure affects patients' ability to carry out even simple activities of daily living and therefore has a negative psychological impact. Many studies reported that anxiety and depression are prevalent among HF patients and it is being associated with high morbidity, mortality and costs. Community HF patients who are diagnosed with depression are usually referred for Improving Access for Psychological Therapies (IAPT). The IAPT services have long waiting lists and many patients in the community still do not have access to IAPT. IAPT (2017) found web-based interventions for psychological therapies for emotional disorders such as depression and anxiety to be as effective as the traditional interventions and yielded positive mental health outcomes.

In this current study, the feasibility and acceptability of the proposed COMPASS web-based intervention will be examined. COMPASS is a web-based therapy (online CBT program) designed for the management of depression and anxiety for patients with long term conditions such as heart failure.

This study will be conducted into three parts and mainly include one-to-one interviews. First, the researcher will use an approach called "think aloud" which is a specific type of interview that allows us to observe the participant while using the proposed COMPASS online using Microsoft Teams. The participant will be asked to log into the COMPASS website and talk to the researcher continuously as possible about what they are thinking or what comes into their mind as they are using the COMPASS website. Following this interview, the researcher will ask the participant to use COMPASS from any internet-connected device for four weeks with weekly follow-up telephone calls. One month after the completion of COMPASS, the researcher will interview the participants.

详细描述

Heart failure (HF) is the inability of the heart muscle to pump enough blood to meet the body's blood and oxygen requirements. The European Society of Cardiology (ESC) described HF as a clinical syndrome resulting from the reduced cardiac output that may be accompanied with high intracardiac pressure during rest or with stress. It is characterized by shortness of breath, fatigue and limited exercise tolerance. The prevalence of HF is increasing worldwide, and HF cases increased by 23% in the United Kingdom (UK) from 2002 to 2014. In the year 2017-2018 in England, 500,000 people were diagnosed with heart failure. According to hospital diagnoses in the UK, there were up to 920,000 people living with HF. Many HF patients develop anxiety and depression due to the pathological similarities in both conditions. The prevalence of major in depression in HF is reported to be around 20-40% that is more than the reported prevalence in the normal population.

The National Institute for Health and Care Excellence (NICE) guidelines on HF emphasized the importance of treating depression in HF but there were no specific treatment options for HF recommended in the document. The ESC HF recommended initiating depression treatment for all HF patients using psychosocial interventions, pharmacological therapy or exercise training. In Southwark and Lambeth Boroughs, the community-based HF patients who are diagnosed with depression are usually referred for psychological treatment such as Improving Access for Psychological Therapies (IAPT) or 3 Dimensions for Long Term Conditions (3DLC). The type of treatment depends on the severity of their depression and the extent to which depression is affecting clients' self-management of HF. So, for persistent and mild to moderate depression or if the depression is not related to HF, the patients will be referred to IAPT for treatment. While, for moderately severe to severe depression and whose depression affects their management of HF, patients will be seen by the team of 3DLC. The IAPT services have long waiting lists and many patients in the community with anxiety and depression still do not have access to IAPT. The impact of the Covid-19 pandemic has increased the burden further on IAPTS services.

This current study builds on our phase 2 study (268951) which is currently using online focus group with community HF nurses (n=5) and qualitative telephone/online interviews with community-based HF patients (n=8) to examine their views and experiences in managing depression and anxiety in the primary setting, and whether the proposed COMPASS, a web-based intervention, can be used for managing depression and anxiety in community-based HF patients. The findings from phase 2 study will be analysed to identify patients' perspectives and readiness to use the web-based COMPASS intervention for managing anxiety and depression in HF.

In this study (phase 3), the feasibility and acceptability of the proposed COMPASS web-based intervention will be examined with community-based HF patients. Web-based interventions such as COMPASS are programs or applications that can be accessed through the website. They are usually developed to change health behaviour, provide education, monitor symptoms or deliver interventions. Barak et al. (2009) defined a web-based intervention as programs that are primarily self-guided and that are delivered online for people requiring health and mental health-related support. These interventions aim to improve knowledge or create awareness through the delivery of health-related content in an interactive web-based program.

IAPT (2017) found web-based interventions for psychological therapies for emotional disorders such as depression and anxiety to be as effective as the traditional interventions and yielded positive mental health outcomes. Web-based interventions allow the intervention to be delivered through a patient-centred approach that is strengthened by the support of trained therapist. With the rapid advancement in technology and the widespread use of the internet, web-based interventions have grown in popularity as they are seen as cost-effective, and easily accessible from a patient perspective (Murray, 2012). Web-based interventions aim to improve self-management skills of patients with chronic diseases such as cardiovascular diseases, diabetes, and arthritis. Web-based interventions for chronic cardiac conditions were reported to be cost-effective, easily accessible by participants through different devices (laptops, smartphones or computers), confidential, non-stigmatizing and acceptable. Patients can easily fit the web-based interventions into their daily life, and it can be easily approached by HF patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • •Community-based HF patients from community HF service and outpatient department with depression and anxiety related to their HF will be invited to participate in the study. The inclusion criteria include:
  • •Adults over 18 years of age;
  • •community-based HF patients capable of providing written/verbal informed consent;
  • •Community-based HF patients with mild to moderately-severe depression (using PHQ-9) with/without anxiety symptoms related to their HF;
  • •community-based HF patients who are not engaging in any psychological treatment at the time of recruitment;
  • •Is fluent in the English language so can fully respond to verbal and written material; and
  • •Has access to the internet and has an electronic device (i.e. computer, laptop etc).

排除标准

  • •The exclusion criteria include community-based HF patients:
  • •With severe depression validated by PHQ-9 score (> 19) as assessed by the researcher;
  • •who are receiving or engaging in other psychological treatment for anxiety and depression;
  • •have active suicidal ideation if reported during the assessment with the researcher.

研究组 & 干预措施

Heart failure patients

Other

patients will try the Compass intervention

干预措施: COMPASS (Behavioral)

结局指标

主要结局

Treatment usability using the System Usability Scale (SUS)

时间窗: This will be measured at weekly basis at each session after using compass and for a total of 4 weeks

SUS scores have a range of 0 to 100. SUS yields a single number representing a composite measure of the overall usability of the intervention being used.

COMPASS Acceptability and feasibility as measured by Treatment Acceptability/Adherence Scale (TAAS) and interviews

时间窗: This will be measured second time at week 4 follow up post Compass use

TAAS is a 10 items self-reported scale rated on a 7- point Likert scale. Possible scores can range from 10 to 70, and higher scores are indicative of higher acceptability of treatment and greater anticipated ability to adhere to it.

COMPASS Acceptability and feasibility as measured by Treatment Acceptability/Adherence Scale (TAAS) and interviews

时间窗: This will be measured at first Think aloud Interview (immediately after first use of compass)

TAAS is a 10 items self-reported scale rated on a 7- point Likert scale. Possible scores can range from 10 to 70, and higher scores are indicative of higher acceptability of treatment and greater anticipated ability to adhere to it.

次要结局

  • changes in depression scores as measured by Patient Health Questionnaire-9 (PHQ-9)(every 2 weeks after using compass. First it will be measures at baseline (before compass) and then every 2 weeks.)
  • changes in anxiety score as measured by Generalised Anxoety Disorder-7 (GAD-7)(every 2 weeks after using compass. First it will be measures at baseline (before compass) and then every 2 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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