Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000505606
Ethics application status
Approved
Date submitted
3/05/2014
Date registered
13/05/2014
Date last updated
13/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive behavioural therapy for the sensation of breathlessness : A pilot study
Scientific title
Does a cognitive behaviour therapy program for sensation of breathlessness combined with comprehensive pulmonary rehabilitation compared to comprehensive pulmonary rehabilitation alone, lead to greater improvements in functional exercise capacity and respiratory related quality of life in people with chronic obstructive pulmonary disease: a pilot study
Secondary ID [1] 284535 0
None
Universal Trial Number (UTN)
U1111-1156-3355
Trial acronym
CBT-BREVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyspnoea 291797 0
Chronic obstructive pulmonary disease 291798 0
Condition category
Condition code
Respiratory 292160 292160 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The cognitive behavioural therapy (CBT) program for the sensation of breathlessness (BREVE) was developed as a sequential series of eight modules (one hour for each of the eight weeks of the comprehensive pulmonary rehabilitation program (CPRP). Each week participants’ attended a group session facilitated by a psychologist, supported by a program manual. Each week’s module included a brief educational component (15 minutes presentation maximum), discussion of a key concept, individual reflective activity, and explanation of homework tasks including examples / demonstration and clarification of the task to be practiced during the supervised exercise sessions for the week. The psychologist also attended the supervised exercise sessions in order to coach individuals while breathless in key tasks and techniques relevant to each module.

Each week of the standard eight week CPRP included two , one hour group exercise sessions supervised by a physiotherapist (circuit training; only one supervised session in week 8) and two hours of knowledge-based group education provided by a variety of health professionals (physiotherapist, psychologist, occupational therapist, respiratory nurse, and dietician) . Participants were also encouraged to exercise daily at home (walking program). The total number of face to face sessions for the CPRP was 31 (16 education and 15 exercise sessions).

The cognitive behavioural therapy program commenced in the first week of the eight week comprehensive pulmonary rehabilitation program.

The BREVE program manual included specific sections for recording activities completed within the group class and for completion of homework tasks.
Intervention code [1] 289297 0
Rehabilitation
Intervention code [2] 289316 0
Behaviour
Intervention code [3] 289317 0
Treatment: Other
Comparator / control treatment
Comprehensive pulmonary rehabilitation

Each week of the standard eight week CPRP included two , one hour group exercise sessions supervised by a physiotherapist (circuit training; only one supervised session in week 8) and two hours of knowledge-based group education provided by a variety of health professionals (physiotherapist, psychologist, occupational therapist, respiratory nurse, and dietician) . Participants were also encouraged to exercise daily at home (walking program). The total number of face to face sessions for the CPRP was 31 (16 education and 15 exercise sessions). For both groups (BREVE pilot and historical control) the comprehensive pulmonary rehabilitation program and health professionals (physiotherapist, psychologist, occupational therapist, respiratory nurse, and dietician) were the same.

The fifty eight participants with COPD in the historical control group completed the comprehensive pulmonary rehabilitation program at the Repatriation General Hospital, Adelaide in 2006/2007.
Control group
Historical

Outcomes
Primary outcome [1] 292037 0
Six minute walk test
Timepoint [1] 292037 0
Post 8 week intervention
Primary outcome [2] 292038 0
St. George’s Respiratory Questionnaire
Timepoint [2] 292038 0
Post eight week intervention
Secondary outcome [1] 308058 0
Volunteered and endorsed descriptors of breathlessness

The sensation of dyspnoea was assessed at rest using a structured interview which records descriptors volunteered by subjects in their own words (Williams et al 2010) and the best three descriptors selected from a pre-existing list of breathlessness descriptors (Mahler et al 1996).


Williams M, Cafarella P, Olds T, Petkov J, Frith P: Affective descriptors of the sensation of breathlessness are more highly associated with severity of impairment than physical descriptors in people with COPD. Chest 2010, 138:315-322.

Mahler DA, Harver A, Lentine T, Scott JA, Beck K, Schwartzstein RM: Descriptors of breathlessness in cardiorespiratory diseases. Am J Resp Crit Care Med 1996, 154:1357-1363.
Timepoint [1] 308058 0
Post eight week intervention
Secondary outcome [2] 308059 0
Participant feedback

Participants were invited to complete a 12 item feedback form specifically developed for the pilot study (four point categorical scale; strongly agree, agree, disagree, strongly disagree) and provide comments on strengths and areas for improvement of the BREVE program.
Timepoint [2] 308059 0
Post eight week intervention

Eligibility
Key inclusion criteria
People with chronic respiratory conditions and associated breathing difficulties, intending to undertake the eight week comprehensive pulmonary rehabilitation program at Repatriation General Hospital (RGH) in Adelaide, South Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive or memory impairment (Mini-Mental State Examination score less than 23/30), clinically unstable respiratory or cardiac diseases or co-morbidities likely to render exercise unsafe (determined by RGH respiratory physician), or were currently registered for lung volume reduction surgery or lung transplantation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Active arm: All people referred and assessed for the one comprehensive pulmonary rehabilitation cycle were sequentially invited to participate in this pilot study. Historical control: 58 people who had completed the same comprehensive pulmonary rehabilitation program in the years preceding the pilot study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Historical control
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For primary outcomes, repeated measures analysis of variance (ANOVA) was used to assess within-group intervention effects (pre to post) and differences in intervention effects between groups (BREVE pilot or control). Effect sizes were calculated (Cohen’s d). For secondary outcomes, McNemar’s test was used to assess proportional changes within each descriptor category for the pilot and control groups and percentage of participants who changed or did not change descriptors within each category calculated. Responses were collated for the feedback form and analysed descriptively for both categorical and opened ended text based items. Categorical options were collapsed into agree or disagree.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/02/2008
Actual
17/03/2008
Date of last participant enrolment
Anticipated
28/04/2008
Actual
8/04/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2398 0
Repatriation Hospital - Daw Park
Recruitment postcode(s) [1] 8047 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 289167 0
University
Name [1] 289167 0
University of South Australia
Country [1] 289167 0
Australia
Primary sponsor type
Individual
Name
Marie Williams
Address
School of Population Health, Sansom Institute for Health Research, University of South Australia, South Australian Health & Medical Research Institute (SAHMRI),North Terrace, Adelaide, South Australia 5000
Country
Australia
Secondary sponsor category [1] 287836 0
None
Name [1] 287836 0
none
Address [1] 287836 0
Country [1] 287836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290941 0
Human Research Ethics Committees of the University of South Australia
Ethics committee address [1] 290941 0
Ethics committee country [1] 290941 0
Australia
Date submitted for ethics approval [1] 290941 0
Approval date [1] 290941 0
06/07/2007
Ethics approval number [1] 290941 0
P153/07
Ethics committee name [2] 290942 0
Repatriation General Hospital Human Research Ethics committee
Ethics committee address [2] 290942 0
Ethics committee country [2] 290942 0
Australia
Date submitted for ethics approval [2] 290942 0
Approval date [2] 290942 0
26/09/2007
Ethics approval number [2] 290942 0
P56/07

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

Contacts
Principal investigator
Name 48086 0
A/Prof Marie T Williams
Address 48086 0
School of Population Health, Sansom Institute for Health Research, University of South Australia, South Australian Health & Medical Research Institute (SAHMRI),North Terrace, Adelaide, South Australia 5000
Country 48086 0
Australia
Phone 48086 0
+61 8 8302 1153
Fax 48086 0
61 8 8302 2794
Email 48086 0
[email protected]
Contact person for public queries
Name 48087 0
Marie T Williams
Address 48087 0
School of Population Health, Sansom Institute for Health Research, University of South Australia, South Australian Health & Medical Research Institute (SAHMRI),North Terrace, Adelaide, South Australia 5000
Country 48087 0
Australia
Phone 48087 0
+61 8 8302 1153
Fax 48087 0
+61 8 8302 2794
Email 48087 0
[email protected]
Contact person for scientific queries
Name 48088 0
Marie T Williams
Address 48088 0
School of Population Health, Sansom Institute for Health Research, University of South Australia, South Australian Health & Medical Research Institute (SAHMRI),North Terrace, Adelaide, South Australia 5000
Country 48088 0
Australia
Phone 48088 0
+61 8 8302 1153
Fax 48088 0
+61 8 8302 2794
Email 48088 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

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