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

Sponsor

Royal Victoria Infirmary (Other)

Overall Status

Unknown status

CT.gov ID

NCT01738711

Collaborator

Manchester University NHS Foundation Trust (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis Cough Breathlessness	Behavioral: Cognitive behavioural therapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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)?

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Feb 1, 2014

Anticipated Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Arm

Intervention/Treatment

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 Names:

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

Outcome Measures

Primary Outcome Measures

validity of tools used [baseline and 12 months]
to determine validity of tools used in pilot study to inform a future, multicentre RCT.
estimation of recruitment rate [baseline to 12 months]
to determine estimation of recruitment rate to inform a future RCT
number of patients needed [baseline to 12 months]
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 [baseline and 3 months]
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 [baseline and 3 months]
to assess change in depression using the Hospital Anxiety and Depression Scale (depression subset) at 3 months.
change in cough frequency [baseline and 3 months]
to assess change in cough frequency using a 24 hour cough monitor
change in Medical Research Council (MRC) dyspnoea scale [baseline and 3 months]
to assess the impact on breathlessness using change in MRC dyspnoea scale at 3 months
change in pulmonary function tests (FVC, TLCO) [baseline and 3 months]
to assess impact on disease severity using pulmonary function tests at 3 months
change in leicester cough questionnaire [baseline and 3 months]
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 [baseline and 6 months]
change in anxiety score using Hospital Anxiety and Depression Scale (anxiety subset) at 6 months
change in Hospital Anxiety and Depression Scale-Anxiety subset [baseline and 9 months]
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 [baseline and 12 months]
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 [baseline and 6 months]
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 [baseline and 9 months]
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 [baseline and 12 months]
to assess change in depression using the Hospital Anxiety and Depression Scale (depression subset) at 12 months.
change in MRC dyspnoea scale [baseline and 6 months]
to assess the impact on breathlessness using change in MRC dyspnoea scale at 6 months
change in MRC dyspnoea scale [baseline and 9 months]
to assess the impact on breathlessness using change in MRC dyspnoea scale at 9 months
change in MRC dyspnoea scale [baseline and 12 months]
to assess the impact on breathlessness using change in MRC dyspnoea scale at 12 months
change in pulmonary function tests (FVC, TLCO) [baseline and 6 months]
to assess impact on disease severity using pulmonary function tests at 6 months
change in pulmonary function tests (FVC, TLCO) [baseline and 9 months]
to assess impact on disease severity using pulmonary function tests at 9 months
change in pulmonary function tests (FVC, TLCO) [baseline and 12 months]
to assess impact on disease severity using pulmonary function tests at 12 months
change in 6 minute walk distance [baseline and 3 months]
to assess impact on disease severity using six minute walk distance and desaturation index at 3 months
change in six minute walk distance [baseline and 6 months]
to assess impact on disease severity using six minute walk distance and desaturation index at 6 months
change in six minute walk distance [baseline and 9 months]
to assess impact on disease severity using six minute walk distance and desaturation index at 9 months
change in six minute walk distance [baseline and 12 months]
to assess impact on disease severity using six minute walk distance and desaturation index at 12 months
change in leicester cough questionnaire [baseline and 6 months]
to assess the change in quality of life using the Leicester cough questionnaire at 6 months
change in leicester cough questionnaire [baseline and 9 months]
to assess the change in quality of life using the Leicester cough questionnaire at 9 months
change in leicester cough questionnaire [baseline and 12 months]
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 [baseline and 3 months]
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 [baseline and 6 months]
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 [baseline and 9 months]
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 [baseline and 12 months]
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 [baseline and 3 months]
to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 3 months
change in generalised anxiety disorder questionnaire [baseline and 6 months]
to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 6 months
change in generalised anxiety disorder questionnaire [baseline and 9 months]
to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 9 months
change in generalised anxiety disorder questionnaire [baseline and 12 months]
to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 12 months
change in EuroQol5 Dimension questionnaire [baseline and 3 months]
to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 3 months
change in EuroQol5 Dimension questionnaire [baseline and 6 months]
to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 6 months
change in EuroQol5 Dimension questionnaire [baseline and 9 months]
to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 9 months
change in EuroQol5 Dimension questionnaire [baseline and 12 months]
to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 12 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).