Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05081947 |
| Other study ID # |
288961 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 11, 2021 |
| Est. completion date |
April 1, 2022 |
Study information
| Verified date |
September 2021 |
| Source |
King's College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
COMPASS is a web-based intervention (online CBT program) that was developed for managing
illness-related anxiety and depression in patients with long-term conditions. COMPASS aims to
support people in managing the challenges of living with a long-term condition. COMPASS is
based on research that shows the benefit of combining mental and physical healthcare. COMPASS
was developed by a team of experienced health psychology researchers and practitioners at
King's College London. The structure and content of COMPASS are based on a systematic review
to identify mechanisms of action which trigger and sustain symptoms of depression and/or
anxiety in the context of LTCs. COMPASS is tailored to gain an understanding of the
difficulties that LTC patients experience and provide information and tools on how to manage
these.
COMPASS is different from other web-based talking therapy because it:
- is tailored to treat low mood and anxiety in the context of living with one or more
long-term conditions.
- uses the latest research evidence to identify mechanisms known to trigger and sustain
symptoms of low mood and anxiety in people with long-term conditions. These mechanisms
are then targeted in the program.
- has been co-developed by people with long-term conditions to improve its acceptability,
utility and ease of use.
The proposed COMPASS program consists of 11 online sessions for patients to work through over
approximately 12 weeks. The sessions can be worked through in any order the patient would
like. The sessions are split into four quadrants - North, East, South and West - which
explore different elements of managing the LTC challenges that were identified from the
evidence-based systematic review. Sessions contain information, interactive tasks, goal
setting and patient stories.
If the proposed COMPASS is found to be applicable to use in HF, this will help patients who
are considered vulnerable and are shielding from, for example, the COVID-19 outbreak. During
the pandemic, patients were unable to attend for psychological therapies that were conducted
face to face, thus the use of COMPASS will assist in delivering the psychological
intervention for a large number of patients anywhere and at any time. In this study, the
acceptability and feasibility of COMPASS as a web-based intervention during the Covid-19
pandemic will be also explored as a virtual therapeutic intervention.
