Condition category
Circulatory System
Date applied
15/05/2017
Date assigned
25/05/2017
Last edited
25/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims:
Atrial fibrillation (AF) is an abnormal heart rhythm characterised by rapid and irregular beating. Often it starts as brief periods of abnormal beating which become longer and possibly constant over time. Most episodes have no symptoms. Occasionally there may be heart palpitations, fainting, light headedness, shortness of breath, or chest pain. The disease is associated with an increased risk of heart failure, dementia, and stroke. Some of the research suggests that this can lead to anxiety and depression in some patients. This study is looking at whether or not patients with AF experience anxiety and depression after being diagnosed and if so, whether or not psychological therapy can help to improve these symptoms. There are different types of psychological therapies, one of which is cognitive behavioural therapy (CBT). CBT is type of a talking therapy that helps people to manage their problems by changing the way they think and behave. It is most commonly used to treat anxiety and depression. The aim of the study is to investigate whether or not CBT helps to reduce anxiety and/or depression among patients with AF compared to usual care.

Who can participate?
Adults with AF who are depressed and/or anxious.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive up to 16 hour-long weekly sessions of CBT. These sessions include discussion of patients’ current reported difficulties, their concerns and misconceptions surrounding the disease and its’ treatment. Those in the second group receive usual care, which involves being given information about self-referral to Therapy services and/or be referred by their GP. At the start of the study and after six and twelve months, participants in both groups complete a range of questionnaires to assess their mental wellbeing.

What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their anxiety and/or depression symptoms because of the therapy they receive. There are unlikely to be any risks of taking part however since these the in-depth therapy sessions may cause some feelings of distress. The therapist will provide support and they will be able to discuss any concerns with them.

Where is the study run from?
Sandwell and West Birmingham Hospitals NHS Trust (UK)

When is study starting and how long is it expected to run for?
April 2016 to September 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Danille Clarkesmith
d.e.clarkesmith@bham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Danielle Clarkesmith

ORCID ID

http://orcid.org/0000-0003-4619-2565

Contact details

University of Birmingham Institute for Cardiovascular Sciences
City Hospital
Birmingham
B18 7QH
United Kingdom
+44 121 507 5086
d.e.clarkesmith@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34498

Study information

Scientific title

Cognitive Behavioural Therapy to reduce anxiety and depression in patients with Atrial Fibrillation

Acronym

CBT-AF

Study hypothesis

The aim of the study is to investigate whether or not the new cognitive behavioural therapy (CBT) intervention helps to reduce anxiety and/or depression among patients with atrial fibrillation compared to people who receive usual care.

Ethics approval

West Midlands- South Birmingham Research Committee, 02/02/2017, ref: 16/WM/0502

Study design

Randomised; Interventional; Design type: Treatment, Screening, Education or Self-Management, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Primary Care, Primary sub-specialty: Cardiovascular disease; UKCRC code/ Disease: Cardiovascular/ Other forms of heart disease

Intervention

Participants will be recruited from GP practices and specialist AF clinics. The potential participant will be screened for eligibility using the GAD-7, PHQ-9, and AFSS questionnaires. Eligible patients will be invited to participate in the trial, consented and randomised, in their GP practice.

CBT arm (intervention arm): CBT will be led by one of two trained therapists and delivered individually, in the patient’s GP practice. There may be up to 16 weekly sessions, each lasting up to 60 minutes, which will include discussion of patients’ current reported difficulties, their concerns and misconceptions surrounding the disease and its’ treatment. Intervention will begin with development of an individualised formulation and treatment plan and goals. Interventions will be chosen in accordance with this but are likely to include CB interventions and tailored to individual needs. Worksheet-based activities with individualised homework tasks will be utilised. Patients in the CBT group can be prescribed antidepressant and/or anti-anxiolytic by their GP, as deemed appropriate. Any newly prescribed psychiatric medication will be recorded. Where patients require further cognitive behavioural therapy sessions, over the allocated 16 sessions per patient, they will be referred for continued care by their GP (with their allocated therapist if possible).

Usual care (routine arm): Those randomised to usual care will be given information about self-referral to Therapy services and/ or be referred by their GP. Patients with moderate anxiety and/or depression could be offered guided self-help talking therapies/CBT by a psychological well-being practitioner, while those with severe anxiety and/or depression would be referred for individual CBT or group therapy while waiting for individual CBT. Researchers will document how many patients were referred, whether services were accessed, what level of treatment was required and how many sessions’ patients attended. This information will be gathered by the discharge letters. Usual care will allow the GP to prescribe medication as deemed appropriate.

Follow-up for participants in both groups will take place at 6 and 12 months post randomisation. If patients in either group require additional treatment relating to their AF they will be referred to Professor Lip's AF clinic based at City Hospital.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Anxiety is measured by using the Generalised Anxiety Disorder -7 Questionnaire (GAD -7) at screening, beginning of each therapy session (CBT arm only) 6 and 12 month follow up
2. Depression is measured by using the Patient Health Questionnaire –9 (PHQ–9) at screening, beginning of each therapy session (CBT arm only) 6 and 12 month follow up

Secondary outcome measures

1. Subjective ratings of AF-related symptoms and AF disease burden will be captured using the Atrial Fibrillation Severity Scale (AFSS) at screening, baseline, beginning of each therapy session (CBT arm only) 6 and 12 month follow up
2. Health outcome is measured by using the EuroQoL-5D-5L Questionnaire (EQ-5D-5L) at baseline, 6 and 12 month follow-up
3. Patient satisfaction will be measured using the Patient satisfaction Survey at 6 and 12 months
4. Health-related quality of life (HRQoL) will be measured using one disease specific, the Atrial Fibrillation Effects on QualiTy –of-Life (AFeQT) questionnaire at baseline, 6 and 12 month follow-up
5. The physical and mental HRQoL will be measured using the Short Form- 12 health questionnaire at baseline, 6 and 12 month follow-up
6. Functional impairment which attributes to the anxiety and/or depression will be measured using the Work and Social Adjustment Scale (WSAS) at baseline, 6 and 12 month follow-up

Overall trial start date

06/04/2016

Overall trial end date

01/09/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and over
2. Diagnosed with atrial fibrillation (AF) within the last 12 months
3. Defined as ‘case’ (score of ≥8 on the GAD-7 and ≥10 on the PHQ-9)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 128; UK Sample Size: 128

Participant exclusion criteria

1. Diagnosed with AF for longer than 12 month
2. Terminal illness
3. Cognitive impairment which prevents them from being able to give informed consent
4. Unable to speak and/or read English.

Recruitment start date

01/09/2017

Recruitment end date

01/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sandwell and West Birmingham Hospitals NHS Trust
Dudley Road
Birmingham
B18 7QH
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Research Governance Team
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 121 415 8011
researchgovernance@contacts.bham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of the findings in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from CBT-AF@contacts.bham.ac.uk

Intention to publish date

01/09/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes