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

• 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.
  
  

• 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
  
  

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.