Plain English Summary
Background and study aims
Many people in the United Kingdom with chronic obstructive pulmonary disease (COPD) also experience feeling anxious or low in their mood. This study aims to see if a treatment called cognitive behavioural therapy (CBT) can help reduce symptoms. Cognitive Behavioural Therapy (CBT) is a method used to explore how we think, feel and act when we have a physical health problem. The benefit of CBT is that it can hopefully change the way patients cope with their illness and symptoms in a practical, problem solving way.
Who can participate?
Patients can participate if they have a confirmed diagnosis of COPD, any gender and any age.
What does the study involve?
Patients are randomly allocated either self-help leaflets to work through or individual appointments with a nurse for up to six sessions of CBT. All patients are followed up after three, six and 12 months with questionnaires to assess their progress.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Royal Victoria Infirmary, New Victoria Wing, Newcastle (UK)
When is study starting and how long is it expected to run for?
June 2011 to October 2014
Who is the main contact?
Ms K Heslop
Trial website
Contact information
Type
Scientific
Primary contact
Ms K Heslop
ORCID ID
Contact details
Royal Victoria Infirmary
New Victoria Wing
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
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karen.heslop@nuth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10519
Study information
Scientific title
A single centre randomised controlled trial to identify if cognitive behavioural therapy delivered by respiratory nurses reduces anxiety and depression in patients with chronic obstructive pulmonary disease (CBT CARE Study).
Acronym
Study hypothesis
A single centre randomised controlled trial to identify if cognitive behavioural therapy delivered by respiratory nurses reduces anxiety & depression in patients with chronic obstructive pulmonary disease at 3, 6 & 12 months.
Ethics approval
Sunderland Ethics Committee, 25/02/2011, ref: 11/NE/0025
Study design
Randomised, interventional, treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Anxiety, depression, respiratory.
Intervention
As of 14/10/2016:
The two interventions were:
1. Group A – CBT Arm (Brief CBT treatment delivered by respiratory nurses).
Group A received a brief CBT intervention called the Lung Manual Programme plus self-help leaflets (Northumberland, Tyne and Wear Mental Health Trust leaflets on panic) and the Self-Help Toolkit were provided. Depression and low mood leaflets were provided if co-existing symptoms of depression were identified. The CBT was delivered by one of four respiratory nurses who had at least three days prior training in CBT with specific study training. Individualised treatment plans were developed to deliver between two and six sessions of CBT at two weekly intervals depending on clinical need. The first session lasted 30 to 45 minutes and follow-up sessions lasted 15 to 30 minutes. CBT therapy was administered in the hospital outpatient clinic or home setting for patients who were housebound.
2. Group B – Active control arm - Self Help Leaflets
Patients in group B were randomised to receive the same self-help leaflets as the CBT group. Patients were provided the leaflets, advised to read them thoroughly and complete the exercises within them. Patients were encouraged to contact their primary care team should further help be required.
Follow-up period: 12 months
Initial
Cognitive Behavioural Therapy, Psychological treatment for anxiety & depression.
Follow Up Length: 12 month(s)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Does CBT delivered by respiratory nurses reduce anxiety (1.5 points on HADS scale).; Timepoint(s): At 3 months
Secondary outcome measures
1. Does CBT delivered by respiratory nurses reduced anxiety & depression compared to standard care measured at timepoint(s) 6 & 12 months
2. Reduction in Hospital Anxiety & Depression Scale of at least 1.5 points compared to standard care measured at timepoint(s): 6 months & 12 months
Overall trial start date
16/06/2011
Overall trial end date
13/10/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient with a confirmed diagnosis of COPD (FVC/FEV1 ratio <70%, NICE, 2010)
2. People with all disease severity will be eligible including mild to moderate (FEV1 >50% predicted) and severe to very severe (<50% predicted)
3. Patients with probable anxiety as defined by Hospital Anxiety and Depression Scale Anxiety Subscale (HADSA)
scores >8
4. Willing to participate in the study and able to provide written informed consent
5. Agreed to attend a minimum of 2 and maximum of 6 CBT sessions
6. Target Gender: Male & Female
7. Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 312; UK Sample Size: 312; Description: 156 patients randomised to either CBT treatment or usual care.
Participant exclusion criteria
1. Patients with HADSA score <8 (within normal range)
2. Patients with known psychosis and personality disorders
3. Patients currently receiving psychological therapy including counselling, psychotherapy including CB
4. Patients unable to engage in CBT e.g. cognitive impairment or dementia)
5. Patients with limited verbal and/or written communication problems
Recruitment start date
16/06/2011
Recruitment end date
13/10/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Victoria Infirmary, New Victoria Wing
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
National Institute of Health Research (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NS
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR/CNO Clinical Academic Training Fellowship (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24498939
Publication citations
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Protocol
Heslop K, Newton J, Baker C, Burns G, Carrick-Sen D, De Soyza A, Effectiveness of cognitive behavioural therapy (CBT) interventions for anxiety in patients with chronic obstructive pulmonary disease (COPD) undertaken by respiratory nurses: the COPD CBT CARE study: (ISRCTN55206395)., BMC Pulm Med, 2013, 13, 62, doi: 10.1186/1471-2466-13-62.