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

NCT01738711 | Unknown

• 1 other identifier: IPF Protocol 12/NE/0309
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis; Cough; Breathlessness

Keywords

Idiopathic pulmonary fibrosis; Cognitive behavioural therapy; Anxiety; Quality of life

Outcome Measures

Primary Outcomes (3)

• validity of tools used

  to determine validity of tools used in pilot study to inform a future, multicentre RCT.

  baseline and 12 months

• estimation of recruitment rate

  to determine estimation of recruitment rate to inform a future RCT

  baseline to 12 months

• 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

Secondary Outcomes (37)

• change in Hospital Anxiety and Depression Scale-Anxiety subset

  baseline and 3 months

• change in Hospital Anxiety and Depression Scale-Depression subset

  baseline and 3 months

• change in cough frequency

  baseline and 3 months

• change in Medical Research Council (MRC) dyspnoea scale

  baseline and 3 months

• change in pulmonary function tests (FVC, TLCO)

  baseline and 3 months

Study Arms (2)

Cognitive Behavioural Therapy

ACTIVE COMPARATOR

Patient in this arm receive 2-6 sessions of cognitive behavioural therapy

Behavioral: Cognitive behavioural therapy

Written information on CBT

PLACEBO COMPARATOR

Patients in this arm do not receive sessions of CBT but receive written information on anxiety control as per standard practice

Interventions

Cognitive behavioural therapy BEHAVIORAL

Patient receive 2-6 sessions depending on individual need. first session is 1 hour duration with additional sessions approximately 30 minutes.

Also known as: CBT

Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Royal Victoria Infirmary: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (2)

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom, NE2 1HP, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom, NE2 1HP, United Kingdom

Location

Related Publications (14)

• 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, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann 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.

  PMID: 21471066 BACKGROUND

• 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. doi: 10.1136/thorax.58.4.339.

  PMID: 12668799 BACKGROUND

• Brown KK. Chronic cough due to chronic interstitial pulmonary diseases: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):180S-185S. doi: 10.1378/chest.129.1_suppl.180S.

  PMID: 16428708 BACKGROUND

• 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. doi: 10.1016/s0003-9993(03)00239-9.

  PMID: 12917854 BACKGROUND

• Doherty MJ, Mister R, Pearson MG, Calverley PM. Capsaicin induced cough in cryptogenic fibrosing alveolitis. Thorax. 2000 Dec;55(12):1028-32. doi: 10.1136/thorax.55.12.1028.

  PMID: 11083888 BACKGROUND

• 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. doi: 10.1183/09031936.97.10071581.

  PMID: 9230251 BACKGROUND

• 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.

  PMID: 19449602 BACKGROUND

• 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. doi: 10.1164/rccm.200304-597OC. Epub 2003 Aug 13.

  PMID: 12917229 BACKGROUND

• 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.

  PMID: 21477349 BACKGROUND

• Madison JM, Irwin RS. Chronic cough in adults with interstitial lung disease. Curr Opin Pulm Med. 2005 Sep;11(5):412-6. doi: 10.1097/01.mcp.0000174249.07762.37.

  PMID: 16093815 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 20375900 BACKGROUND

• 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

  BACKGROUND

• 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. No abstract available.

  PMID: 18757459 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Cough; Dyspnea; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ian Forrest, MRCP UK, PhD

  Newcastle upon Tyne Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Forrest, MRCP UK, PhD

CONTACT

0191 2829576; ian.forrest@nuth.nhs.uk

Karen Corder, BSc (Hons) Adult Nursing

CONTACT

0191 2820151; karen.corder@nuth.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Respiratory Physician

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

GB (2)