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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01738711
• Date of registration: 28/11/2012
• Prospective Registration: Yes
• Primary sponsor: Royal Victoria Infirmary
• Public title: Does CBT Improve the Perception/Impact of Cough and Breathlessness in IPF Patients
• Scientific 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)?
• Date of first enrolment: December 2012
• Target sample size: 30
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01738711
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: Ian Forrest, MRCP UK, PhD

• Name: Ian Forrest, MRCP UK, PhD
• Affiliation: Newcastle upon Tyne Hospitals NHS Foundation Trust

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Breathlessness

Cough

Intervention(s)

Behavioral: Cognitive behavioural therapy

Primary Outcome(s)

number of patients needed [Time Frame: baseline to 12 months]

estimation of recruitment rate [Time Frame: baseline to 12 months]

validity of tools used [Time Frame: baseline and 12 months]

Secondary Outcome(s)

change in generalised anxiety disorder questionnaire [Time Frame: baseline and 12 months]

change in leicester cough questionnaire [Time Frame: baseline and 12 months]

change in 6 minute walk distance [Time Frame: baseline and 3 months]

change in EuroQol5 Dimension questionnaire [Time Frame: baseline and 12 months]

change in EuroQol5 Dimension 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-Depression subset [Time Frame: baseline and 6 months]

change in King's brief interstitial lung disease questionnaire [Time Frame: baseline and 12 months]

change in King's brief interstitial lung disease questionnaire [Time Frame: baseline and 3 months]

change in MRC dyspnoea scale [Time Frame: baseline and 9 months]

change in Hospital Anxiety and Depression Scale-Anxiety subset [Time Frame: baseline and 9 months]

change in MRC dyspnoea scale [Time Frame: baseline and 6 months]

change in EuroQol5 Dimension questionnaire [Time Frame: baseline and 6 months]

change in generalised anxiety disorder questionnaire [Time Frame: baseline and 3 months]

change in Hospital Anxiety and Depression Scale-Anxiety subset [Time Frame: baseline and 12 months]

change in Hospital Anxiety and Depression Scale-Anxiety subset [Time Frame: baseline and 3 months]

change in generalised anxiety disorder questionnaire [Time Frame: baseline and 9 months]

change in Hospital Anxiety and Depression Scale-Depression subset [Time Frame: baseline and 3 months]

change in King's brief interstitial lung disease questionnaire [Time Frame: baseline and 6 months]

change in MRC dyspnoea scale [Time Frame: baseline and 12 months]

change in leicester cough questionnaire [Time Frame: baseline and 9 months]

change in six minute walk distance [Time Frame: baseline and 6 months]

change in pulmonary function tests (FVC, TLCO) [Time Frame: baseline and 12 months]

change in six minute walk distance [Time Frame: baseline and 12 months]

change in Hospital Anxiety and Depression Scale-Depression subset [Time Frame: baseline and 12 months]

change in leicester cough questionnaire [Time Frame: baseline and 3 months]

change in cough frequency [Time Frame: baseline and 3 months]

change in EuroQol5 Dimension questionnaire [Time Frame: baseline and 9 months]

change in pulmonary function tests (FVC, TLCO) [Time Frame: baseline and 9 months]

change in King's brief interstitial lung disease questionnaire [Time Frame: baseline and 9 months]

change in leicester cough questionnaire [Time Frame: baseline and 6 months]

change in pulmonary function tests (FVC, TLCO) [Time Frame: baseline and 6 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 six minute walk distance [Time Frame: baseline and 9 months]

change in generalised anxiety disorder questionnaire [Time Frame: baseline and 6 months]

change in Hospital Anxiety and Depression Scale-Depression subset [Time Frame: baseline and 9 months]

Secondary ID(s)

IPF Protocol 12/NE/0309

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital of South Manchester NHS Foundation Trust