Assessing the Acceptability and Feasibility of COMPASS

NCT05081947 | Completed

• 1 other identifier: 288961
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Depression; Anxiety

Outcome Measures

Primary Outcomes (3)

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

  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.

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

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

  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.

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

• Treatment usability using the System Usability Scale (SUS)

  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.

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

Secondary Outcomes (2)

• 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.

Study Arms (1)

Heart failure patients

OTHER

patients will try the Compass intervention

Behavioral: COMPASS

Interventions

COMPASS BEHAVIORAL

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 (LTC) (https://compass-ltc.org/). An example of the patient login page can be viewed here: www.compass-southwark.co.uk. COMPASS aims to support people in managing the challenges of living with a long-term condition. COMPASS is based on research which shows the benefit of combining mental and physical healthcare. 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.

Heart failure patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Heart Failure Community Service

London, Westminester, SW1V 2QP, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 18, 2021
• Study Start: November 11, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: October 14, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)