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Trial registered on ANZCTR


Registration number
ACTRN12614000915651
Ethics application status
Approved
Date submitted
11/08/2014
Date registered
27/08/2014
Date last updated
28/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of telephone based cognitive behavioural therapy (CBT) for patients with chronic lung disease and anxiety and/or depression undergoing pulmonary rehabilitation to evaluate the effect on symptoms of anxiety and depression, quality of life, and exacerbations
Scientific title
Randomised controlled trial of a brief telephone based cognitive behavioural therapy (CBT) for patients with chronic lung disease and anxiety and/or depression undergoing pulmonary rehabilitation to evaluate the effect on quality of life, symptoms of anxiety and depression, and exacerbation rate
Secondary ID [1] 285064 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic lung disease (Chronic Obstructive Pulmonary Disease , Asthma, Idiopathic pulmonary fibrosis and bronchiectasis) 292589 0
Anxiety 292590 0
Depression 292591 0
Condition category
Condition code
Respiratory 292893 292893 0 0
Chronic obstructive pulmonary disease
Mental Health 292894 292894 0 0
Anxiety
Mental Health 292896 292896 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention will be 6 Cognitive behavioural therapy (CBT) sessions administered by psychology interns
Usual care compromised of medical treatment and pulmonary rehabilitation
6 Cognitive behavioural therapy (CBT) sessions will be divided into:
2 face-to-face individual sessions of 1 hour each, within the first 4 weeks of pulmonary rehabilitation
4 phone sessions of 60 minutes each will be undertaken for counseling, each session will be fortnightly within the first 2 months after the face-to-face sessions.
CBT intervention will be standardised following a manual written by the TPCH psychology department.
Intervention code [1] 289903 0
Behaviour
Intervention code [2] 290052 0
Rehabilitation
Comparator / control treatment
Usual care compromised of medical treatment and pulmonary rehabilitation.
Participants in the Control group will not receive face to face intervention. After rehabilitation participants will receive fortnightly telephone contacts of 5-10 minutes at same periods as the intervention group. Telephone contact will entail assessment of symptoms.
Control group
Active

Outcomes
Primary outcome [1] 292769 0
Symptoms of anxiety using Geriatric Anxiety Inventory (GAI)
Timepoint [1] 292769 0
12 months
Primary outcome [2] 292948 0
Symptoms of depression using Geriatric Depression scale (GDS)
Timepoint [2] 292948 0
12 months
Secondary outcome [1] 309631 0
Disease-specific questionnaires:
The St. George respiratory Questionnaire (SGRQ) to assess quality of life in COPD patients, asthma, ILD and bronchiectasis.
Asthma patients will also answer the Asthma Quality of Life Questionnaire (AQLQ) and Asthma Control Questionnaire (ACQ)
Timepoint [1] 309631 0
12 months
Secondary outcome [2] 309632 0
Emergent health care utilization (primary care & hospital care) assessed by data linkage to patient medical records and a questionnaire (designed for this study to asses exacerbation rate) at 6 months and 12 months intervals.
Timepoint [2] 309632 0
12 months
Secondary outcome [3] 309633 0
6 minute walk distance
Timepoint [3] 309633 0
8 weeks
Secondary outcome [4] 309634 0
Pulmonary rehabilitation attendance and a structured interview aimed to assess participation
Timepoint [4] 309634 0
8 weeks

Eligibility
Key inclusion criteria
Chronic Lung disease
Undergoing pulmonary rehabilitation
Clinical or subclinical anxiety or depression, defined by Geriatric Anxiety Inventory (GAI) score greater or equal to 4/20 , and/or Geriatric Depression scale (GDS) of greater or equal to 4/15
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give written informed consent.
Known psychotic disorder.
Cognitive impairment determined by Montreal Cognitive Assessment (MOCA) score of <25/30.
Current enrolment in other interventional clinical trials that would potentially interfere with this study.

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)
All patients undergoing pulmonary rehabilitation will be assessed for symptoms of anxiety and depression
After consent given patients will be randomised on a 1:1 basis to intervention (CBT) or control. Allocation concealment will be done by central randomisation by computer.
Patients will be stratified at randomisation for lung condition and severity.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated software package.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be by intention to treat. Descriptive statistics will be used for exploratory analysis. t-tests and Chi-squared tests will be used to test for differences between continuous and categorical outcomes, respectively, between the intervention and control groups. A p value (two-tailed) <0.05 will be considered statistically significant.
A sample size of 50 intervention and 50 control participants has 80% power at alpha (significance) level 0.05 to detect a 3-fold increase in significant improvement of anxiety or depression scores, based on the assumption of improvement 10% of the control group and 33% of the intervention group.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/09/2014
Actual
15/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2786 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 8479 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 289669 0
Hospital
Name [1] 289669 0
New Investigator Grants
The Prince Charles Hospital Foundation
Country [1] 289669 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
Rode Road, Chermside, 4032
Queensland.
Country
Australia
Secondary sponsor category [1] 288360 0
University
Name [1] 288360 0
The University of Queensland
Address [1] 288360 0
Brisbane, St Lucia QLD 4072
Country [1] 288360 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aim of this study is to assess the impact and viability of CBT as a treatment for patients with chronic lung disease undergoing pulmonary rehabilitation. We expect that CBT and rehabilitation will have a synergic effect, enhancing rehabilitation benefits and improving patients’ quality of life through improved patients coping skills and psychological and physical well being
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50250 0
Dr Marsus I Pumar
Address 50250 0
The Prince Charles Hospital
Rode Road
Chermside, Postcode 4032
Queensland
Country 50250 0
Australia
Phone 50250 0
+61 04 37739874
Fax 50250 0
Email 50250 0
[email protected]
Contact person for public queries
Name 50251 0
Marsus I Pumar
Address 50251 0
The Prince Charles Hospital
Rode Road
Chermside, Postcode 4032
Queensland
Country 50251 0
Australia
Phone 50251 0
+61 04 37739874
Fax 50251 0
Email 50251 0
[email protected]
Contact person for scientific queries
Name 50252 0
Ian Yang
Address 50252 0
The Prince Charles Hospital
Rode Road
Chermside, Postcode 4032
Queensland
Country 50252 0
Australia
Phone 50252 0
+61-7-31395050
Fax 50252 0
Email 50252 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3976Plain language summaryNo The addition of CBT to pulmonary rehabilitation in... [More Details]

Documents added automatically
No additional documents have been identified.