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Trial registered on ANZCTR


Registration number
ACTRN12617000653369
Ethics application status
Approved
Date submitted
18/04/2017
Date registered
5/05/2017
Date last updated
14/07/2022
Date data sharing statement initially provided
30/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of cognitive behaviour therapy on anxiety, depression and breathlessness in patients with Chronic Obstructive Pulmonary Disease
Scientific title
Effect of cognitive behaviour therapy on anxiety, depression and breathlessness in patients with Chronic Obstructive Pulmonary Disease (COPD): A randomised controlled trial.
Secondary ID [1] 291725 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 302907 0
depression 302908 0
anxiety 302909 0
Condition category
Condition code
Respiratory 302395 302395 0 0
Chronic obstructive pulmonary disease
Mental Health 302404 302404 0 0
Depression
Mental Health 302405 302405 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behaviour Therapy:
The intervention will be delivered by an experienced Clinical Psychologist weekly in individual sessions of approximately one hour duration. While the aim is for face-to-face sessions, 2 telephone sessions have been factored in, given this population is likely to suffer from ill health during the 10 week treatment time. In addition, the eight session will be delivered over 10 weeks, allowing time to reschedule appointments due to ill health.
As patients will be presenting with different anxiety and depressive disorders, therapy needs to be individualised to the patient. Thus a number of core and optional CBT modules are described.
Adherence to the scheduled visits will be recorded by study staff and all efforts to flexible with times and dates will be made by study staff to improve adherence
The core modules contain such things as
1. Psychoeducation: Anxiety, Depression, CBT model
Aim: To increase awareness of how COPD may affect psychological well-being and how psychological symptoms and behavioural patterns associated with anxiety/depression may add to the burden of COPD.
2. Exploring feelings of loss associated with losing their wellness role
Aim: To explore the experience of adjusting to ill health/COPD, validating feelings of loss, and exploring what may help with adjustment to their new role.
3. Breathlessness-related anxiety action plan.
Aim: To help contain anxiety about becoming breathless, through the provision of a concrete individualised “plan” that outlines the steps involved in managing breathlessness and anxiety about being breathless, and thus reinforcing strategies learnt in their involvement in the Westmead Hospital Breathlessness Clinic.
Optional modules such as :
Mood monitoring
Aim: To gain insight into patient’s thoughts and activities that influence mood, and patterns of mood over time.
Fear-based exposure
Aim: To address avoidance of anxiety-provoking situations with graded exposure (imaginary and in vivo), in order to desensitise the patient and increase tolerance.
Desensitisation to traumatic breathlessness-related memories.
Aim: To reduce the impact and intensity of distressing memories related to disturbing life experiences related to breathlessness in the past, using eye-movement desensitisation and reprocessing (EMDR).
Intervention code [1] 297810 0
Treatment: Other
Intervention code [2] 297840 0
Behaviour
Comparator / control treatment
The comparator/control group will be waitlisted to undergo the same intervention but after a 10 week waitlist.
Control group
Active

Outcomes
Primary outcome [1] 301803 0
change in Chronic Respiratory Questionnaire
Timepoint [1] 301803 0
baseline to 10 weeks
Primary outcome [2] 301804 0
change Hospital Anxiety and Depression Scale
Timepoint [2] 301804 0
baseline to 10 weeks
Secondary outcome [1] 333903 0
change in breathlessness numerical rating scales
Timepoint [1] 333903 0
baseline to 10 weeks
Secondary outcome [2] 333904 0
change in chronic obstructive pulmonary disease assessment test
Timepoint [2] 333904 0
baseline to 10 weeks
Secondary outcome [3] 333905 0
change in Dyspnea Management Questionnaire
Timepoint [3] 333905 0
baseline to 10 weeks
Secondary outcome [4] 333906 0
change in daily step count as measured by pedometer worn for 7 days
Timepoint [4] 333906 0
baseline to 10 weeks

Eligibility
Key inclusion criteria
a) Severe or very severe COPD by Gold criteria (FEV1<60% predicted; FEV1/FVC ratio <70%).
b) Breathlessness (modified Medical Research Council dyspnea scale scores (mMRC > 2).
c) Completion of the Westmead Hospital Breathlessness Clinic within 9 months
d) Elevated anxiety or depression scores (Hospital Anxiety and Depression Scale - Anxiety score > 8 or Hospital Anxiety and Depression Scale - Depression score> 8).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) A history of a recent (< 4 weeks) moderate to severe exacerbation of COPD, requiring hospitalisation.
b) Bed bound.
c) A diagnosis of dementia or cognitive impairment.
d) Insufficient proficiency in English for participation in CBT.
e) A current active diagnosis of cancer, other primary respiratory disease, substance abuse, other uncontrolled medical disorder.
f) Inability to comply with study procedures in the opinion of the investigators or the participant’s usual medical team
g) already receiving psychological intervention

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a computer generated randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
This is a randomised controlled, clinical trial comparing CBT intervention with waitlist control. Randomisation will be assigned using a random number generator. Randomisation will be 1 : 1.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics of demographic information will be reported for both groups. The control and intervention groups will be compared on primary outcome measures via within- subject change scores using two sample t-tests (utilising a Bonferroni corrected p value, p = 0.05/3 = .017). All analyses will be by intention to treat, last observation carried forward. Participants that have completed less than 6 sessions of CBT within 10 weeks will be classified at treatment non-completers. Analysis target n=46

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/05/2017
Actual
7/07/2017
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
60
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7863 0
Westmead Hospital - Westmead
Recruitment hospital [2] 22815 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 15809 0
2145 - Westmead
Recruitment postcode(s) [2] 38100 0
2560 - Campbelltown
Recruitment postcode(s) [3] 38101 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 296224 0
Hospital
Name [1] 296224 0
Westmead hospital
Country [1] 296224 0
Australia
Primary sponsor type
Hospital
Name
Westmead hospital
Address
Cnr Hawkesbury & Darcy Rd,
Westmead ,NSW 2145
Country
Australia
Secondary sponsor category [1] 295137 0
None
Name [1] 295137 0
None
Address [1] 295137 0
None
Country [1] 295137 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297463 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 297463 0
Ethics committee country [1] 297463 0
Australia
Date submitted for ethics approval [1] 297463 0
15/06/2016
Approval date [1] 297463 0
06/09/2016
Ethics approval number [1] 297463 0
Au REDHREC16/WMEAD/236 (4746)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1643 1643 0 0
/AnzctrAttachments/372765-HREC approval letter _ 4746.pdf

Contacts
Principal investigator
Name 74118 0
Prof John Wheatley
Address 74118 0
Department of Respiratory & Sleep medicine
Westmead Hospital
Cnr Hawkesbury & Darcy Rd
Westmead NSW 2145
Country 74118 0
Australia
Phone 74118 0
+61298456797
Fax 74118 0
+61298457286
Email 74118 0
john.wheatley@sydney.edu.au
Contact person for public queries
Name 74119 0
Ester Klimkeit
Address 74119 0
Department of Respiratory & Sleep medicine
Westmead Hospital
Cnr Hawkesbury & Darcy Rd
Westmead NSW 2145
Country 74119 0
Australia
Phone 74119 0
+61288909836
Fax 74119 0
+61288907286
Email 74119 0
Ester.Klimkeit@health.nsw.gov.au
Contact person for scientific queries
Name 74120 0
John Wheatley
Address 74120 0
Department of Respiratory & Sleep medicine
Westmead Hospital
Cnr Hawkesbury & Darcy Rd
Westmead NSW 2145
Country 74120 0
Australia
Phone 74120 0
+61298456797
Fax 74120 0
+61298457286
Email 74120 0
john.wheatley@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.