The Newcastle COPD CBT CARE Study
| ISRCTN | ISRCTN55206395 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55206395 |
| Secondary identifying numbers | 10519 |
- Submission date
- 20/10/2011
- Registration date
- 20/10/2011
- Last edited
- 21/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Royal Victoria Infirmary
New Victoria Wing
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
| karen.heslop@nuth.nhs.uk |
Study information
| Study design | Randomised, interventional, treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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). |
| Study objectives | 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(s) | Sunderland Ethics Committee, 25/02/2011, ref: 11/NE/0025 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 16/06/2011 |
| Completion date | 13/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 312; UK Sample Size: 312; Description: 156 patients randomised to either CBT treatment or usual care. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/06/2011 |
| Date of final enrolment | 13/10/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Government
Richmond House
79 Whitehall
London
SW1A 2NS
United Kingdom
| Website | http://www.nihr.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0187kwz08 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/11/2013 | Yes | No | |
| Results article | results | 23/11/2018 | 21/01/2019 | Yes | No |
Editorial Notes
21/01/2019: Publication reference added
17/01/2017: internal review.
14/10/2016: Interventions were updated (timestamped in field). Plain English summary was added.
12/10/2016: 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.
