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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Royal Victoria Infirmary
Sponsor:
Collaborator:
University Hospital of South Manchester NHS Foundation Trust
Information provided by (Responsible Party):
Ian Forrest, Royal Victoria Infirmary
ClinicalTrials.gov Identifier:
NCT01738711
First received: November 28, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Idiopathic Pulmonary Fibrosis
Cough
Breathlessness
Behavioral: Cognitive behavioural therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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)?

Resource links provided by NLM:


Further study details as provided by Royal Victoria Infirmary:

Primary Outcome Measures:
  • validity of tools used [ Time Frame: baseline and 12 months ] [ Designated as safety issue: Yes ]
    to determine validity of tools used in pilot study to inform a future, multicentre RCT.

  • estimation of recruitment rate [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    to determine estimation of recruitment rate to inform a future RCT

  • number of patients needed [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    estimation of parameters such as variance of outcome variables to enable calculation of sample size in a future RCT.


Secondary Outcome Measures:
  • change in Hospital Anxiety and Depression Scale-Anxiety subset [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    to assess change in anxiety scores using the Hospital Anxiety and Depression Scale (anxiety subset) at 3 months.

  • change in Hospital Anxiety and Depression Scale-Depression subset [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    to assess change in depression using the Hospital Anxiety and Depression Scale (depression subset) at 3 months.

  • change in cough frequency [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    to assess change in cough frequency using a 24 hour cough monitor

  • change in Medical Research Council (MRC) dyspnoea scale [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    to assess the impact on breathlessness using change in MRC dyspnoea scale at 3 months

  • change in pulmonary function tests (FVC, TLCO) [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    to assess impact on disease severity using pulmonary function tests at 3 months

  • change in leicester cough questionnaire [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the Leicester cough questionnaire at 3 months

  • change in Hospital Anxiety and Depression Scale-Anxiety subset [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    change in anxiety score using Hospital Anxiety and Depression Scale (anxiety subset) at 6 months

  • change in Hospital Anxiety and Depression Scale-Anxiety subset [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    change in anxiety score using the Hospital Anxiety and Depression Scale (anxiety subset) at 9 months

  • change in Hospital Anxiety and Depression Scale-Anxiety subset [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    change in anxiety score using the Hospital Anxiety and Depression Scale (anxiety subset) at 12 months

  • change in Hospital Anxiety and Depression Scale-Depression subset [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    to assess change in depression using the Hospital Anxiety and Depression Scale (depression subset) at 6 months.

  • change in Hospital Anxiety and Depression Scale-Depression subset [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    to assess change in depression using the Hospital Anxiety and Depression Scale (depression subset) at 9 months.

  • change in Hospital Anxiety and Depression Scale-Depression subset [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    to assess change in depression using the Hospital Anxiety and Depression Scale (depression subset) at 12 months.

  • change in MRC dyspnoea scale [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    to assess the impact on breathlessness using change in MRC dyspnoea scale at 6 months

  • change in MRC dyspnoea scale [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    to assess the impact on breathlessness using change in MRC dyspnoea scale at 9 months

  • change in MRC dyspnoea scale [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    to assess the impact on breathlessness using change in MRC dyspnoea scale at 12 months

  • change in pulmonary function tests (FVC, TLCO) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    to assess impact on disease severity using pulmonary function tests at 6 months

  • change in pulmonary function tests (FVC, TLCO) [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    to assess impact on disease severity using pulmonary function tests at 9 months

  • change in pulmonary function tests (FVC, TLCO) [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    to assess impact on disease severity using pulmonary function tests at 12 months

  • change in 6 minute walk distance [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    to assess impact on disease severity using six minute walk distance and desaturation index at 3 months

  • change in six minute walk distance [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    to assess impact on disease severity using six minute walk distance and desaturation index at 6 months

  • change in six minute walk distance [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    to assess impact on disease severity using six minute walk distance and desaturation index at 9 months

  • change in six minute walk distance [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    to assess impact on disease severity using six minute walk distance and desaturation index at 12 months

  • change in leicester cough questionnaire [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the Leicester cough questionnaire at 6 months

  • change in leicester cough questionnaire [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the Leicester cough questionnaire at 9 months

  • change in leicester cough questionnaire [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the Leicester cough questionnaire at 12 months

  • change in King's brief interstitial lung disease questionnaire [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the King's brief Interstitial Lung Disease questionnaire at 3 months

  • change in King's brief interstitial lung disease questionnaire [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the King's brief Interstitial Lung Disease questionnaire at 6 months

  • change in King's brief interstitial lung disease questionnaire [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the King's brief Interstitial Lung Disease questionnaire at 9 months

  • change in King's brief interstitial lung disease questionnaire [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the King's brief Interstitial Lung Disease questionnaire at 12 months

  • change in generalised anxiety disorder questionnaire [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 3 months

  • change in generalised anxiety disorder questionnaire [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 6 months

  • change in generalised anxiety disorder questionnaire [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 9 months

  • change in generalised anxiety disorder questionnaire [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 12 months

  • change in EuroQol5 Dimension questionnaire [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 3 months

  • change in EuroQol5 Dimension questionnaire [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 6 months

  • change in EuroQol5 Dimension questionnaire [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 9 months

  • change in EuroQol5 Dimension questionnaire [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 12 months


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive Behavioural Therapy
Patient in this arm receive 2-6 sessions of cognitive behavioural therapy
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.
Other Name: CBT
Placebo Comparator: Written information on CBT
Patients in this arm do not receive sessions of CBT but receive written information on anxiety control as per standard practice

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738711

Contacts
Contact: Ian Forrest, MRCP UK, PhD 0191 2829576 ian.forrest@nuth.nhs.uk
Contact: Karen Corder, BSc (Hons) Adult Nursing 0191 2820151 karen.corder@nuth.nhs.uk

Locations
United Kingdom
Royal Victoria Infirmary Not yet recruiting
Newcastle upon Tyne, United Kingdom, NE2 1HP
Contact: Laura A Tanner, MBBS, MRCP    07766415805    loll_tanner@yahoo.co.uk   
Principal Investigator: Ian Forrest, MRCP UK, PhD         
Sub-Investigator: Laura A Tanner, MBBS, MRCP         
Royal Victoria Infirmary Not yet recruiting
Newcastle upon Tyne, United Kingdom, NE2 1HP
Contact: Laura Tanner, MBBS, MRCP    07766415805    loll_tanner@yahoo.co.uk   
Principal Investigator: Ian Forrest, MRCP UK, PhD         
Sub-Investigator: Laura Tanner, MBBS, MRCP         
Sponsors and Collaborators
Royal Victoria Infirmary
University Hospital of South Manchester NHS Foundation Trust
Investigators
Principal Investigator: Ian Forrest, MRCP UK, PhD Newcastle upon Tyne Hospitals NHS Foundation Trust
  More Information

Publications:
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

Responsible Party: Ian Forrest, Consultant Respiratory Physician, Royal Victoria Infirmary
ClinicalTrials.gov Identifier: NCT01738711     History of Changes
Other Study ID Numbers: IPF Protocol 12/NE/0309
Study First Received: November 28, 2012
Last Updated: December 11, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Victoria Infirmary:
Idiopathic pulmonary fibrosis
Cognitive behavioural therapy
Anxiety
Quality of life

Additional relevant MeSH terms:
Dyspnea
Fibrosis
Cough
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on September 22, 2014