Condition category
Mental and Behavioural Disorders
Date applied
20/10/2011
Date assigned
20/10/2011
Last edited
14/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
-
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 measures

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

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

http://www.nihr.ac.uk/

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24498939

Publication citations

  1. 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.

Additional files

Editorial Notes

The registration was initiated on 16/05/2011. A first submission was received by ISRCTN on 16/05/2011 and it was then superseded by a second submission on 20/10/2011. Registration was finalised on 20/10/2011. The recruitment started in 16/06/2011, after initiation of public registration. 14/10/2016: Interventions were updated (timestamped in field). Plain English summary was added