ANZCTR - Registration

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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]

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)

Anxiety

Depression

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Mental Health

Anxiety

Mental Health

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]

Behaviour

Intervention code [2]

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]

Symptoms of anxiety using Geriatric Anxiety Inventory (GAI)

Timepoint [1]

12 months

Primary outcome [2]

Symptoms of depression using Geriatric Depression scale (GDS)

Timepoint [2]

12 months

Secondary outcome [1]

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]

12 months

Secondary outcome [2]

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]

12 months

Secondary outcome [3]

6 minute walk distance

Timepoint [3]

8 weeks

Secondary outcome [4]

Pulmonary rehabilitation attendance and a structured interview aimed to assess participation

Timepoint [4]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Prince Charles Hospital - Chermside

Recruitment postcode(s) [1]

4032 - Chermside

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

New Investigator Grants
The Prince Charles Hospital Foundation

Address [1]

Rode Road, Chermside, 4032
Queensland.

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Prince Charles Hospital

Address

Rode Road, Chermside, 4032
Queensland.

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Queensland

Address [1]

Brisbane, St Lucia QLD 4072

Country [1]

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

Dr Marsus I Pumar

Address

The Prince Charles Hospital
Rode Road
Chermside, Postcode 4032
Queensland

Country

Australia

Phone

+61 04 37739874

Fax

[email protected]

Contact person for public queries

Name

Marsus I Pumar

Address

The Prince Charles Hospital
Rode Road
Chermside, Postcode 4032
Queensland

Country

Australia

Phone

+61 04 37739874

Fax

[email protected]

Contact person for scientific queries

Name

Ian Yang

Address

The Prince Charles Hospital
Rode Road
Chermside, Postcode 4032
Queensland

Country

Australia

Phone

+61-7-31395050

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		The addition of CBT to pulmonary rehabilitation in... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically