Idiopathic Pulmonary FibrosisNCT01738711
Does CBT Improve the Perception/Impact of Cough and Breathlessness in IPF Patients
A study testing Cognitive behavioural therapy in people with Idiopathic Pulmonary Fibrosis and Cough, run by Royal Victoria Infirmary at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Cough, Breathlessness
- What is being tested?
- Cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Dec 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE2 1HP
Laura A Tanner, MBBS, MRCP, 07766415805, loll_tanner@yahoo.co.uk
Ian Forrest, MRCP UK, PhD
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE2 1HP
Laura Tanner, MBBS, MRCP, 07766415805, loll_tanner@yahoo.co.uk
Ian Forrest, MRCP UK, PhD
About this study
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)?
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis, Cough, Breathlessness
- Being tested
- Cognitive behavioural therapy
- Keywords
- Idiopathic pulmonary fibrosis, Cognitive behavioural therapy, Anxiety, Quality of life
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Cough, Dyspnea, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural therapyBehavioural
Also called CBT
Patient receive 2-6 sessions depending on individual need. first session is 1 hour duration with additional sessions approximately 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy | Active comparator | Patient in this arm receive 2-6 sessions of cognitive behavioural therapy Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
validity of tools used
to determine validity of tools used in pilot study to inform a future, multicentre RCT.
Measured: baseline and 12 months
estimation of recruitment rate
to determine estimation of recruitment rate to inform a future RCT
Measured: 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.
Measured: baseline to 12 months
Secondary outcomes (37)
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.
Measured: baseline and 3 months
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.
Measured: baseline and 3 months
change in cough frequency
to assess change in cough frequency using a 24 hour cough monitor
Measured: baseline and 3 months
change in Medical Research Council (MRC) dyspnoea scale
to assess the impact on breathlessness using change in MRC dyspnoea scale at 3 months
Measured: baseline and 3 months
change in pulmonary function tests (FVC, TLCO)
to assess impact on disease severity using pulmonary function tests at 3 months
Measured: baseline and 3 months
change in leicester cough questionnaire
to assess the change in quality of life using the Leicester cough questionnaire at 3 months
Measured: baseline and 3 months
change in Hospital Anxiety and Depression Scale-Anxiety subset
change in anxiety score using Hospital Anxiety and Depression Scale (anxiety subset) at 6 months
Measured: baseline and 6 months
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
Measured: baseline and 9 months
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
Measured: baseline and 12 months
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.
Measured: baseline and 6 months
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.
Measured: baseline and 9 months
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.
Measured: baseline and 12 months
change in MRC dyspnoea scale
to assess the impact on breathlessness using change in MRC dyspnoea scale at 6 months
Measured: baseline and 6 months
change in MRC dyspnoea scale
to assess the impact on breathlessness using change in MRC dyspnoea scale at 9 months
Measured: baseline and 9 months
change in MRC dyspnoea scale
to assess the impact on breathlessness using change in MRC dyspnoea scale at 12 months
Measured: baseline and 12 months
change in pulmonary function tests (FVC, TLCO)
to assess impact on disease severity using pulmonary function tests at 6 months
Measured: baseline and 6 months
change in pulmonary function tests (FVC, TLCO)
to assess impact on disease severity using pulmonary function tests at 9 months
Measured: baseline and 9 months
change in pulmonary function tests (FVC, TLCO)
to assess impact on disease severity using pulmonary function tests at 12 months
Measured: baseline and 12 months
change in 6 minute walk distance
to assess impact on disease severity using six minute walk distance and desaturation index at 3 months
Measured: baseline and 3 months
change in six minute walk distance
to assess impact on disease severity using six minute walk distance and desaturation index at 6 months
Measured: baseline and 6 months
change in six minute walk distance
to assess impact on disease severity using six minute walk distance and desaturation index at 9 months
Measured: baseline and 9 months
change in six minute walk distance
to assess impact on disease severity using six minute walk distance and desaturation index at 12 months
Measured: baseline and 12 months
change in leicester cough questionnaire
to assess the change in quality of life using the Leicester cough questionnaire at 6 months
Measured: baseline and 6 months
change in leicester cough questionnaire
to assess the change in quality of life using the Leicester cough questionnaire at 9 months
Measured: baseline and 9 months
change in leicester cough questionnaire
to assess the change in quality of life using the Leicester cough questionnaire at 12 months
Measured: baseline and 12 months
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
Measured: baseline and 3 months
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
Measured: baseline and 6 months
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
Measured: baseline and 9 months
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
Measured: baseline and 12 months
change in generalised anxiety disorder questionnaire
to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 3 months
Measured: baseline and 3 months
change in generalised anxiety disorder questionnaire
to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 6 months
Measured: baseline and 6 months
change in generalised anxiety disorder questionnaire
to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 9 months
Measured: baseline and 9 months
change in generalised anxiety disorder questionnaire
to assess the change in quality of life using the Generalised anxiety disorder questionnaire at 12 months
Measured: baseline and 12 months
change in EuroQol5 Dimension questionnaire
to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 3 months
Measured: baseline and 3 months
change in EuroQol5 Dimension questionnaire
to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 6 months
Measured: baseline and 6 months
change in EuroQol5 Dimension questionnaire
to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 9 months
Measured: baseline and 9 months
change in EuroQol5 Dimension questionnaire
to assess the change in quality of life using the EuroQol5 Dimension questionnaire at 12 months
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Victoria Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Principal investigator, Ian Forrest, Royal Victoria Infirmary
- Investigators
- Ian Forrest, MRCP UK, PhD, Principal investigator, Newcastle upon Tyne Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738711
- Sponsor's protocol ID
- IPF Protocol 12/NE/0309
- Status last verified
- Dec 2012
- First submitted
- 28 Nov 2012
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21471066Birring 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.
PubMed 12668799Brown 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.
PubMed 16428708de 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.
PubMed 12917854Doherty 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.
PubMed 11083888Eiser 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.
PubMed 9230251Heslop 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.
PubMed 19449602Hope-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.
PubMed 12917229Jones 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.
PubMed 21477349Madison 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.
PubMed 16093815Patel 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
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.
PubMed 20375900Shipley 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
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.
PubMed 18757459
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)?
- ClinicalTrials.gov ID
- NCT01738711
- Acronym / sponsor ID
- IPF Protocol 12/NE/0309
- Conditions
- Idiopathic Pulmonary Fibrosis, Cough, Breathlessness
- Keywords
- Idiopathic pulmonary fibrosis, Cognitive behavioural therapy, Anxiety, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal Victoria InfirmaryUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- Dec 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy | Active comparator | Behavioral: Cognitive behavioural therapyPatient in this arm receive 2-6 sessions of 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural therapyAlso: CBTPatient receive 2-6 sessions depending on individual need. first session is 1 hour duration with additional sessions approximately 30 minutes. | Behavioural | Cognitive Behavioural Therapy |
Primary outcome
validity of tools used
Time frame: baseline and 12 months
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
to determine estimation of recruitment rate to inform a future RCT
number of patients needed
Time frame: baseline to 12 months
estimation of parameters such as variance of outcome variables to enable calculation of sample size in a future RCT.
37 secondary outcomes
change in Hospital Anxiety and Depression Scale-Anxiety subset
Time frame: baseline and 3 months
change in Hospital Anxiety and Depression Scale-Depression subset
Time frame: baseline and 3 months
change in cough frequency
Time frame: baseline and 3 months
change in Medical Research Council (MRC) dyspnoea scale
Time frame: baseline and 3 months
change in pulmonary function tests (FVC, TLCO)
Time frame: baseline and 3 months
change in leicester cough questionnaire
Time frame: baseline and 3 months
change in Hospital Anxiety and Depression Scale-Anxiety subset
Time frame: baseline and 6 months
change in Hospital Anxiety and Depression Scale-Anxiety subset
Time frame: baseline and 9 months
change in Hospital Anxiety and Depression Scale-Anxiety subset
Time frame: baseline and 12 months
change in Hospital Anxiety and Depression Scale-Depression subset
Time frame: baseline and 6 months
change in Hospital Anxiety and Depression Scale-Depression subset
Time frame: baseline and 9 months
change in Hospital Anxiety and Depression Scale-Depression subset
Time frame: baseline and 12 months
change in MRC dyspnoea scale
Time frame: baseline and 6 months
change in MRC dyspnoea scale
Time frame: baseline and 9 months
change in MRC dyspnoea scale
Time frame: baseline and 12 months
change in pulmonary function tests (FVC, TLCO)
Time frame: baseline and 6 months
change in pulmonary function tests (FVC, TLCO)
Time frame: baseline and 9 months
change in pulmonary function tests (FVC, TLCO)
Time frame: baseline and 12 months
change in 6 minute walk distance
Time frame: baseline and 3 months
change in six minute walk distance
Time frame: baseline and 6 months
change in six minute walk distance
Time frame: baseline and 9 months
change in six minute walk distance
Time frame: baseline and 12 months
change in leicester cough questionnaire
Time frame: baseline and 6 months
change in leicester cough questionnaire
Time frame: baseline and 9 months
change in leicester cough questionnaire
Time frame: baseline and 12 months
change in King's brief interstitial lung disease questionnaire
Time frame: baseline and 3 months
change in King's brief interstitial lung disease questionnaire
Time frame: baseline and 6 months
change in King's brief interstitial lung disease questionnaire
Time frame: baseline and 9 months
change in King's brief interstitial lung disease questionnaire
Time frame: baseline and 12 months
change in generalised anxiety disorder questionnaire
Time frame: baseline and 3 months
change in generalised anxiety disorder questionnaire
Time frame: baseline and 6 months
change in generalised anxiety disorder questionnaire
Time frame: baseline and 9 months
change in generalised anxiety disorder questionnaire
Time frame: baseline and 12 months
change in EuroQol5 Dimension questionnaire
Time frame: baseline and 3 months
change in EuroQol5 Dimension questionnaire
Time frame: baseline and 6 months
change in EuroQol5 Dimension questionnaire
Time frame: baseline and 9 months
change in EuroQol5 Dimension questionnaire
Time frame: baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
- Background: PubMed 21471066Raghu 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.
- Background: PubMed 12668799Birring 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.
- Background: PubMed 16428708Brown 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.
- Background: PubMed 12917854de 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.
- Background: PubMed 11083888Doherty 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.
- Background: PubMed 9230251Eiser 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.
- Background: PubMed 19449602Heslop 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.
- Background: PubMed 12917229Hope-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.
- Background: PubMed 21477349Jones 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.
- Background: PubMed 16093815Madison 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.
- BackgroundPatel 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: PubMed 20375900Ryerson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Forrest, MRCP UK, PhD principal investigator
Newcastle upon Tyne Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural therapy in people with Idiopathic Pulmonary Fibrosis and Cough, run by Royal Victoria Infirmary at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ian Forrest, MRCP UK, PhD (0191 2829576, ian.forrest@nuth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity of tools used (time frame: baseline and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01738711, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.