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Trial registered on ANZCTR


Registration number
ACTRN12616001039471
Ethics application status
Approved
Date submitted
1/08/2016
Date registered
4/08/2016
Date last updated
4/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of cognitive behavioural therapy and/or simulation-based learning resources on the mental health of chronic obstructive pulmonary disease patients.
Scientific title
A randomised controlled trial testing the efficacy and cost benefit of cognitive
behavioural therapy and/or simulation-based learning resources on the mental health
outcomes of chronic obstructive pulmonary disease patients
Secondary ID [1] 289805 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 299719 0
Anxiety 299720 0
Depression 299721 0
Condition category
Condition code
Respiratory 299652 299652 0 0
Chronic obstructive pulmonary disease
Mental Health 299653 299653 0 0
Anxiety
Mental Health 299654 299654 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Group cognitive behavioural therapy (CBT)
CBT was conducted by a clinical psychologist in groups of 3–7 people. CBT involves a structured program that recognises the way people think affects the way they feel. It teaches people to think rationally about common difficulties, helping to change their thought patterns and the way they react to certain situations. CBT can be as effective as medication to treat depression and anxiety. Our CBT program consisted of two half-day sessions (totalling 9 hours) a fortnight apart and a one-hour telephone booster session four weeks later. The sessions were semi-structured in nature and included both CBT global concepts and those that were specific to people with COPD. A manual was provided to participants for referral to CBT concepts.

The topics covered during the sessions and provided in the manual included:
1. Background information - how to recognise anxiety and panic attacks, depression and the link between mental health and COPD.
2. Automatic thoughts
3. Cognitive distortions
4. Relaxation
5. Reclaiming your confidence (catastrophising and self-talk)
6. The influence activities have on your mood (e.g. increase the 'beautifuls')
7. Assertiveness training.

2) ‘Breathing New Life’ self-management cognitive behavioural therapy resource (DVD)
The ‘Breathing New Life’ self-management simulation-based CBT learning resource (DVD) contained the same concepts covered by the CBT group. The DVD included 7 chapters (including an introduction) which involved 6 vignettes presenting various scenarios likely to be encountered by the participants. The same clinical psychologist who conducted the group sessions was part of the DVD and provided CBT concepts on how individuals could change their behaviour and thoughts to improve their mental health. There was also an accompanying manual provided to the participants which reinforced concepts within the DVD. The DVD/manual covered the same topics as outlined in the group CBT intervention.

Participants were asked to watch one DVD chapter per week (approximately 10 mins) and complete the accompanying section of the manual (approximately 10-20 mins).

In total, participants were given 6 weeks for the DVD to be completed. A researcher telephoned each participant once a week to monitor compliance. Each call lasted <5 minutes on average and telephone coaching was deliberately avoided. If any queries arose, participants were referred to a clinical psychologist.
Intervention code [1] 295476 0
Behaviour
Intervention code [2] 295507 0
Treatment: Other
Comparator / control treatment
Usual care group for anxiety and depression was left to the discretion of the treating general practitioner (GP), as is standard practice. Letters countersigned by the participants’ respiratory physician were sent to their GPs advising of the participant’s clinically significant levels of anxiety and/or depression.
Control group
Active

Outcomes
Primary outcome [1] 299118 0
Beck Anxiety Inventory (BAI)
Timepoint [1] 299118 0
A week after the completion of the intervention (post-intervention) and 3, 6 , 9 and 12 months post-intervention.
Primary outcome [2] 299134 0
Beck Depression Inventory (BDI-II)
Timepoint [2] 299134 0
A week after the completion of the intervention (post-intervention) and 3, 6 , 9 and 12 months post-intervention.
Secondary outcome [1] 326229 0
St George's Respiratory Questionnaire - quality of life
Timepoint [1] 326229 0
A week after the completion of the intervention (post-intervention) and 3, 6 , 9 and 12 months post-intervention.
Secondary outcome [2] 326290 0
Hospital utilisation by self report (this was decided prospectivelyl)
Timepoint [2] 326290 0
One year post-intervention
Secondary outcome [3] 326291 0
Cost effectiveness of intervention by economic analysis. This will be completed from data linkage to hospital records and Western Australian costs for emergency presentation and hospital admissions at the time of the hospital utilisation.
Timepoint [3] 326291 0
One year post-intervention
Secondary outcome [4] 326296 0
All cause hospitalisations by data linkage to medical records (this was decided during the trial)
Timepoint [4] 326296 0
Two years pre-intervention and one year post-intervention
Secondary outcome [5] 326343 0
Hospital and Anxiety Depression Scale (HAD-S)
Timepoint [5] 326343 0
A week after the completion of the intervention (post-intervention) and 3, 6 , 9 and 12 months post-intervention.

Eligibility
Key inclusion criteria
1) A confirmed diagnosis of COPD by respiratory physicians
2) A positive screen for anxiety and/or depression on the BAI and BDI-II, respectively.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Life expectancy of less than six months
2) Currently involved in another research study
3) An illness exacerbation resulting in hospitalisation within the previous month
4) Diagnosis of dementia
5) Known difficulty with either their eye-sight, fluency in English or filling out self-report measures.

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)
Allocation not conealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by an independent person to the research team member pulling out a treatment group from an enclosed container.
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
A power analysis was conducted using G*Power (v3.1.9.2), setting alpha=.05 and beta=.80 for a MANOVA with six repeated measures for three groups. The analysis suggested that in order to detect a statistically significant difference between groups (Critical F=1.86) for a medium effect size (f=.25), a sample size of 45 participants per group would be required. This would be the equivalent of detecting a sustained difference in group means of 1-point for the BAI and BDI-II over the course of the study. Assuming a 30% drop-out rate, this indicates a sample size of 64 participants was required per group.

It was proposed to analyse the trial data using the multiple analyses of variance (MANOVA) technique for repeated measures designs, as recommended by O’Brien and Kaiser. All continuous measures collected for each group will be entered, such as physiological variables, anxiety and depression measures (BAI, BDI-II), quality of life measures (SGRQ) and health service utilisation (e.g., ED visits, hospital bed days).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/02/2013
Date of last participant enrolment
Anticipated
Actual
18/09/2013
Date of last data collection
Anticipated
Actual
17/10/2014
Sample size
Target
192
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6340 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 6348 0
Rockingham General Hospital - Cooloongup
Recruitment postcode(s) [1] 13875 0
6000 - Perth
Recruitment postcode(s) [2] 13891 0
6168 - Cooloongup

Funding & Sponsors
Funding source category [1] 294191 0
Government body
Name [1] 294191 0
State Health Research Advisory Council, Department of Health Western Australia
Country [1] 294191 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 293030 0
None
Name [1] 293030 0
Address [1] 293030 0
Country [1] 293030 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295594 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 295594 0
Ethics committee country [1] 295594 0
Australia
Date submitted for ethics approval [1] 295594 0
05/09/2012
Approval date [1] 295594 0
05/11/2012
Ethics approval number [1] 295594 0
EC2012/140
Ethics committee name [2] 295595 0
Edith Cowan University
Ethics committee address [2] 295595 0
Ethics committee country [2] 295595 0
Australia
Date submitted for ethics approval [2] 295595 0
12/11/2012
Approval date [2] 295595 0
30/11/2012
Ethics approval number [2] 295595 0
8544
Ethics committee name [3] 295605 0
South Metropolitan Health Service HREC
Ethics committee address [3] 295605 0
Ethics committee country [3] 295605 0
Australia
Date submitted for ethics approval [3] 295605 0
21/02/2013
Approval date [3] 295605 0
01/05/2013
Ethics approval number [3] 295605 0
R/13/43
Ethics committee name [4] 295606 0
Department of Health Western Australia HREC
Ethics committee address [4] 295606 0
Ethics committee country [4] 295606 0
Australia
Date submitted for ethics approval [4] 295606 0
19/11/2013
Approval date [4] 295606 0
12/03/2014
Ethics approval number [4] 295606 0
2013/80

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67874 0
Dr Natalie Strobel
Address 67874 0
Edith Cowan University
270 Joondalup Dr,
Joondalup WA 6027
Country 67874 0
Australia
Phone 67874 0
+61 8 9340 7507
Fax 67874 0
Email 67874 0
n.strobel@ecu.edu.au
Contact person for public queries
Name 67875 0
Natalie Strobel
Address 67875 0
Edith Cowan University
270 Joondalup Dr,
Joondalup WA 6027
Country 67875 0
Australia
Phone 67875 0
+61 8 9340 7507
Fax 67875 0
Email 67875 0
n.strobel@ecu.edu.au
Contact person for scientific queries
Name 67876 0
Natalie Strobel
Address 67876 0
Edith Cowan University
270 Joondalup Dr,
Joondalup WA 6027
Country 67876 0
Australia
Phone 67876 0
+61 8 9340 7507
Fax 67876 0
Email 67876 0
n.strobel@ecu.edu.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.