Does CBT Improve the Perception/Impact of Cough and Breathlessness in IPF Patients

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Does Cognitive Behavioural Therapy (CBT) Delivered by a Respiratory Nurse Reduce Anxiety and the Impact of Cough and Breathlessness on Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF)?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01738711
• Other study ID #: IPF Protocol 12/NE/0309
• Status: Not yet recruiting
• Phase: N/A
• First received: November 28, 2012
• Last updated: December 11, 2012
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: December 2012
• Source: Royal Victoria Infirmary
• Contact: Ian Forrest, MRCP UK, PhD
• Phone: 0191 2829576
• Email: ian.forrest[@]nuth.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive lung disease of unknown cause for which there is no effective medical treatment. The main symptoms are increasing breathlessness and cough which can significantly impact on quality of life (QOL) often leading to anxiety and depression. The focus of disease management is shifting from pharmacological attempts to reduce disease progression to managing symptoms and a more holistic approach. Cognitive behavioural therapy (CBT) is increasingly used to treat anxiety and depression in chronic disease. Our investigators aim to determine whether CBT can reduce anxiety and depression related to symptoms and improve QOL in patients with IPF. This study will compare CBT intervention (Group 1) against standard treatment (Group 2). Patients will be recruited from a specialist IPF clinic - all patients attending with IPF who suffer from anxiety will be eligible to participate in the study. The study aims to recruit 30 patients (15 in each group). Patients will be randomly allocated into each group using an envelope concealment system. At entry a baseline visit will be conducted with information gathered regarding disease severity, hospital admissions, medication, symptoms (subjective and objective), quality of life and anxiety and depression using questionnaires and routine clinical tests. Patients will then receive CBT intervention (Group 1) or no intervention (Group 2). Patients receiving CBT will undergo a maximum of 6 (minimum of 2) individual therapy sessions. Follow up visits for both groups will be conducted at 3, 6, 9 and 12 months with the same information gathered as at the baseline visit.

Description:

Medical therapies (e.g. prednisolone, azathioprine and N-acetylcysteine) have not shown any benefit in patients with IPF and may cause harm. Therefore the focus of management has shifted towards a more holistic approach-management of the symptoms and how patients cope with these, in a chronic progressive terminal disease. Anxiety is recognised to contribute to patients' perceptions of symptoms and quality of life. CBT is being increasingly used in other chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD) where there is some evidence that it reduces anxiety and breathlessness. Currently there is no evidence regarding its use in IPF. If CBT is shown to reduce anxiety and help patients cope with symptoms of cough and breathlessness then it can be integrated into the care of all IPF patients to improve quality of life.

All patients attending our specialist IPF clinic will be asked to complete a hospital anxiety and depression questionnaire (HADS). All those with anxiety (HADS-A of equal to or greater than 8) will be eligible for entry. Study information will be provided to these patients and they will then be contacted between 24 and 48 hours later by telephone to confirm they wish to enter the study. If they wish to participate a hospital visit will be arranged to complete informed consent, gather baseline information and be randomised. If allocated to the CBT intervention group they will then receive a maximum of 6 (minimum of 2) sessions of CBT on an individual basis. Patients allocated to the placebo group will receive written information on anxiety management. All patients will attend four more clinic visits at three, six, nine and twelve months after randomisation. At each clinic visit they will complete five questionnaires (totalling 60 questions) and undergo lung function and six minute walk test. They will be consented to wear a cough monitor for a 24 hour period at both baseline and 3 month visits. The cough monitor records the number of times a patient coughs and how long they cough for during a 24 hour period. A small microphone is attached to the clothing and another small microphone to the chest wall which is connected to a small recording device. The device is carried around the waist. The patient will then return the cough monitor the following day. The monitor records not only coughing sounds but also other sounds around the microphone. However, computer software is used to remove parts of the recording where there is no sound, such as when reading or sleeping. It is also designed to remove distant noises, such as another person's conversation or noise from a television but this depends on how loud or close the noise is to the microphone.

The anonymised recordings will be analysed by a trained researcher at Manchester University who counts the number of coughs. The recordings are kept confidential and are stored anonymously at the University of Manchester for a period of 15 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

diagnosis of IPF confirmed by a specialist IPF MDT according to ATS/ERS criteria, agreement to participate and provide written, informed consent, agreement to attend a minimum of 2 and maximum of 6 CBT sessions.

Exclusion Criteria:

HADS-A equal or more than eight, Known psychiatric disorders, psychosis or personality disorders, currently receiving psychological therapy including counselling and/or cognitive behavioural therapy (CBT), cognitive impairment e.g. dementia preventing engagement with CBT, unwilling to engage in CBT, verbal and/or written communication problems limiting ability to engage with CBT or provide written consent (all attempts made to include patients in whom English is not their first language by using an interpreter).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breathlessness
• Cough
• Dyspnea
• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Behavioral:
• Cognitive behavioural therapy
Patient receive 2-6 sessions depending on individual need. first session is 1 hour duration with additional sessions approximately 30 minutes.

Locations

Country	Name	City	State
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne

Sponsors (2)

Lead Sponsor	Collaborator
Royal Victoria Infirmary	University Hospital of South Manchester NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (14)

Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003 Apr;58(4):339-43. — View Citation

Bradley B, Branley HM, Egan JJ, Greaves MS, Hansell DM, Harrison NK, Hirani N, Hubbard R, Lake F, Millar AB, Wallace WA, Wells AU, Whyte MK, Wilsher ML; British Thoracic Society Interstitial Lung Disease Guideline Group, British Thoracic Society Standards of Care Committee; Thoracic Society of Australia; New Zealand Thoracic Society; Irish Thoracic Society. Interstitial lung disease guideline: the British Thoracic Society in collaboration with the Thoracic Society of Australia and New Zealand and the Irish Thoracic Society. Thorax. 2008 Sep;63 Suppl 5:v1-58. doi: 10.1136/thx.2008.101691. Erratum in: Thorax. 2008 Nov;63(11):1029. multiple author names added. — View Citation

Brown KK. Chronic cough due to chronic interstitial pulmonary diseases: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):180S-185S. Review. — View Citation

de Godoy DV, de Godoy RF. A randomized controlled trial of the effect of psychotherapy on anxiety and depression in chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2003 Aug;84(8):1154-7. — View Citation

Doherty MJ, Mister R, Pearson MG, Calverley PM. Capsaicin induced cough in cryptogenic fibrosing alveolitis. Thorax. 2000 Dec;55(12):1028-32. — View Citation

Eiser N, West C, Evans S, Jeffers A, Quirk F. Effects of psychotherapy in moderately severe COPD: a pilot study. Eur Respir J. 1997 Jul;10(7):1581-4. — View Citation

Heslop K, De Soyza A, Baker CR, Stenton C, Burns GP. Using individualised cognitive behavioural therapy as a treatment for people with COPD. Nurs Times. 2009 Apr 14-20;105(14):14-7. — View Citation

Hope-Gill BD, Hilldrup S, Davies C, Newton RP, Harrison NK. A study of the cough reflex in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2003 Oct 15;168(8):995-1002. Epub 2003 Aug 13. — View Citation

Jones RM, Hilldrup S, Hope-Gill BD, Eccles R, Harrison NK. Mechanical induction of cough in Idiopathic Pulmonary Fibrosis. Cough. 2011 Apr 10;7:2. doi: 10.1186/1745-9974-7-2. — View Citation

Madison JM, Irwin RS. Chronic cough in adults with interstitial lung disease. Curr Opin Pulm Med. 2005 Sep;11(5):412-6. Review. — View Citation

Patel AS et al. The assessment of health related quality of life in interstitial lung disease with the King's brief interstitial lung disease questionnaire (K-ILD). Thorax 2011: A61

Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Müller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schünemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL. — View Citation

Ryerson CJ, Collard HR, Pantilat SZ. Management of dyspnea in interstitial lung disease. Curr Opin Support Palliat Care. 2010 Jun;4(2):69-75. doi: 10.1097/SPC.0b013e3283392b51. Review. — View Citation

Shipley MD, Hardy T, Heslop K, Forrest IA. Identifying anxiety and depression in interstitial lung disease: use of a simple outpatient screening tool. British Thoracic Society Winter Meeting 2009

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	validity of tools used	to determine validity of tools used in pilot study to inform a future, multicentre RCT.	baseline and 12 months	Yes
Primary	estimation of recruitment rate	to determine estimation of recruitment rate to inform a future RCT	baseline to 12 months	No
Primary	number of patients needed	estimation of parameters such as variance of outcome variables to enable calculation of sample size in a future RCT.	baseline to 12 months	No
Secondary	change in Hospital Anxiety and Depression Scale-Anxiety subset	to assess change in anxiety scores using the Hospital Anxiety and Depression Scale (anxiety subset) at 3 months.	baseline and 3 months	No
Secondary	change in Hospital Anxiety and Depression Scale-Depression subset	to assess change in depression using the Hospital Anxiety and Depression Scale (depression subset) at 3 months.	baseline and 3 months	No
Secondary	change in cough frequency	to assess change in cough frequency using a 24 hour cough monitor	baseline and 3 months	No
Secondary	change in Medical Research Council (MRC) dyspnoea scale	to assess the impact on breathlessness using change in MRC dyspnoea scale at 3 months	baseline and 3 months	No
Secondary	change in pulmonary function tests (FVC, TLCO)	to assess impact on disease severity using pulmonary function tests at 3 months	baseline and 3 months	No
Secondary	change in leicester cough questionnaire	to assess the change in quality of life using the Leicester cough questionnaire at 3 months	baseline and 3 months	No
Secondary	change in Hospital Anxiety and Depression Scale-Anxiety subset	change in anxiety score using Hospital Anxiety and Depression Scale (anxiety subset) at 6 months	baseline and 6 months	No
Secondary	change in Hospital Anxiety and Depression Scale-Anxiety subset	change in anxiety score using the Hospital Anxiety and Depression Scale (anxiety subset) at 9 months	baseline and 9 months	No
Secondary	change in Hospital Anxiety and Depression Scale-Anxiety subset	change in anxiety score using the Hospital Anxiety and Depression Scale (anxiety subset) at 12 months	baseline and 12 months	No
Secondary	change in Hospital Anxiety and Depression Scale-Depression subset	to assess change in depression using the Hospital Anxiety and Depression Scale (depression subset) at 6 months.	baseline and 6 months	No
Secondary	change in Hospital Anxiety and Depression Scale-Depression subset	to assess change in depression using the Hospital Anxiety and Depression Scale (depression subset) at 9 months.	baseline and 9 months	No
Secondary	change in Hospital Anxiety and Depression Scale-Depression subset	to assess change in depression using the Hospital Anxiety and Depression Scale (depression subset) at 12 months.	baseline and 12 months	No
Secondary	change in MRC dyspnoea scale	to assess the impact on breathlessness using change in MRC dyspnoea scale at 6 months	baseline and 6 months	No
Secondary	change in MRC dyspnoea scale	to assess the impact on breathlessness using change in MRC dyspnoea scale at 9 months	baseline and 9 months	No
Secondary	change in MRC dyspnoea scale	to assess the impact on breathlessness using change in MRC dyspnoea scale at 12 months	baseline and 12 months	No
Secondary	change in pulmonary function tests (FVC, TLCO)	to assess impact on disease severity using pulmonary function tests at 6 months	baseline and 6 months	No
Secondary	change in pulmonary function tests (FVC, TLCO)	to assess impact on disease severity using pulmonary function tests at 9 months	baseline and 9 months	No
Secondary	change in pulmonary function tests (FVC, TLCO)	to assess impact on disease severity using pulmonary function tests at 12 months	baseline and 12 months	No
Secondary	change in 6 minute walk distance	to assess impact on disease severity using six minute walk distance and desaturation index at 3 months	baseline and 3 months	No
Secondary	change in six minute walk distance	to assess impact on disease severity using six minute walk distance and desaturation index at 6 months	baseline and 6 months	No
Secondary	change in six minute walk distance	to assess impact on disease severity using six minute walk distance and desaturation index at 9 months	baseline and 9 months	No
Secondary	change in six minute walk distance	to assess impact on disease severity using six minute walk distance and desaturation index at 12 months	baseline and 12 months	No
Secondary	change in leicester cough questionnaire	to assess the change in quality of life using the Leicester cough questionnaire at 6 months	baseline and 6 months	No
Secondary	change in leicester cough questionnaire	to assess the change in quality of life using the Leicester cough questionnaire at 9 months	baseline and 9 months	No
Secondary	change in leicester cough questionnaire	to assess the change in quality of life using the Leicester cough questionnaire at 12 months	baseline and 12 months	No
Secondary	change in King's brief interstitial lung disease questionnaire	to assess the change in quality of life using the King's brief Interstitial Lung Disease questionnaire at 3 months	baseline and 3 months	No
Secondary	change in King's brief interstitial lung disease questionnaire	to assess the change in quality of life using the King's brief Interstitial Lung Disease questionnaire at 6 months	baseline and 6 months	No
Secondary	change in King's brief interstitial lung disease questionnaire	to assess the change in quality of life using the King's brief Interstitial Lung Disease questionnaire at 9 months	baseline and 9 months	No
Secondary	change in King's brief interstitial lung disease questionnaire	to assess the change in quality of life using the King's brief Interstitial Lung Disease questionnaire at 12 months	baseline and 12 months	No
Secondary	change in generalised anxiety disorder questionnaire	to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 3 months	baseline and 3 months	No
Secondary	change in generalised anxiety disorder questionnaire	to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 6 months	baseline and 6 months	No
Secondary	change in generalised anxiety disorder questionnaire	to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 9 months	baseline and 9 months	No
Secondary	change in generalised anxiety disorder questionnaire	to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 12 months	baseline and 12 months	No
Secondary	change in EuroQol5 Dimension questionnaire	to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 3 months	baseline and 3 months	No
Secondary	change in EuroQol5 Dimension questionnaire	to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 6 months	baseline and 6 months	No
Secondary	change in EuroQol5 Dimension questionnaire	to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 9 months	baseline and 9 months	No
Secondary	change in EuroQol5 Dimension questionnaire	to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 12 months	baseline and 12 months	No