Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000254897
Ethics application status
Approved
Date submitted
14/02/2012
Date registered
29/02/2012
Date last updated
29/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Telephone Cognitive Behavioural Therapy for people with chronic obstructive pulmonary disease.
Scientific title
Telephone Cognitive Behavioural Therapy for the treatment of depression and anxiety associated with chronic obstructive pulmonary disease: a pragmatic randomized controlled trial.
Secondary ID [1] 262423 0
Nil
Universal Trial Number (UTN)
U1111-1128-3105
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 268112 0
Depression 268113 0
Anxiety 268114 0
Condition category
Condition code
Respiratory 268255 268255 0 0
Chronic obstructive pulmonary disease
Mental Health 268256 268256 0 0
Depression
Mental Health 268257 268257 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of a treatment course principally consisting of telephone administered Cognitive Behavioural Therapy (CBT). Specifically it will start with a face-to-face session of 50 minutes duration at the outpatient clinic or the patient's home followed by eight scheduled weekly telephone calls of up to 30 minutes in length. The interventions include behavioural strategies such as behavioural activation, activity scheduling, relaxation training, exposure hierarchies and social skills training, as well as cognitive strategies, such as cognitive restructuring, structured problem solving and behavioural experiments. The therapist administering the telephone calls will be a registered or provisionally registered psychologist who is experienced in the delivery of telephone CBT and has knowledge of chronic obstructive pulmonary disease (COPD) education. The therapist will receive supervision by one of the Associate Researchers on the project who is a Clinical Psychologist with the relevant endorsement as a supervisor. Telephone sessions with be audio recorded to facilitate supervision.
Participants will undertake assessments at screening, baseline, and two follow-up assessments (one at nine weeks and 17 weeks post commencement of intervention). Assessments will consist of administration of questionnaires. The intervention will be administered in addition to the usual care received by the participants.
Intervention code [1] 266796 0
Treatment: Other
Intervention code [2] 284381 0
Behaviour
Comparator / control treatment
The active control group will be provided with usual care plus a course consisting of one face-to-face session of 50 minutes duration either at the outpatient clinic or in the patient's home followed by eight scheduled weekly telephone calls of up to 30 minutes duration providing general psychosocial support. The usual care means that the participants remain under the management of their respiratory physician or the Pulmonary Rehabilitation Clinic and they will continue to receive mediacations and any other treatments as determined by their health care provider. Participants will undertake assessments at screening, baseline, and two follow-up assessments (one at nine weeks and 17 weeks post commencement of placebo). Assessments will consist of administration of questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 268983 0
Mean Beck Anxiety Inventory (BAI) score
Timepoint [1] 268983 0
At baseline and at 9 and 17 weeks post commencement of intervention/active control.
Primary outcome [2] 268984 0
Mean Patient Health Questionnaire - 9 (PHQ-9) score (depression scale)
Timepoint [2] 268984 0
At baseline and at 9 and 17 weeks post commencement of intervention/active control.
Secondary outcome [1] 276751 0
Mean COPD Assessment Test score
Timepoint [1] 276751 0
At baseline and at 9 and 17 weeks post commencement of intervention/active control.
Secondary outcome [2] 276752 0
Mean Client Satisfaction Questionnaire score
Timepoint [2] 276752 0
At 9 and weeks post commencement of intervention/active control.
Secondary outcome [3] 276763 0
Number of acute hospital episodes experienced in previous eight weeks
Timepoint [3] 276763 0
At baseline and at 9 and 17 weeks post commencement of intervention/active control.
Secondary outcome [4] 276764 0
Number of attendances at pulmonary rehabilitation sessions in previous eight weeks
Timepoint [4] 276764 0
At baseline and at 9 and 17 weeks post commencement of intervention/active control.
Secondary outcome [5] 296003 0
Mean Assessment of Quality of Life (AQoL-4D) score
Timepoint [5] 296003 0
At baseline and at 9 and 17 weeks post commencement of intervention/active control.
Secondary outcome [6] 296004 0
Mean score General Self-Efficacy Scale score
Timepoint [6] 296004 0
At baseline and at 9 and 17 weeks post commencement of intervention/active control.
Secondary outcome [7] 296005 0
Mean score on Working Alliance Inventory
Timepoint [7] 296005 0
At 9 and weeks post commencement of intervention/active control.
Secondary outcome [8] 296006 0
Costs of Illness including medical treatments, equipment, working hours lost
Timepoint [8] 296006 0
Measured across 16 week period beginning at commencment of intervention/active control.

Eligibility
Key inclusion criteria
Be over 45 years of age,
Have a HADS score > 8,
Have a PHQ-9 score > 10,
Have a diagnosis of COPD
Living in the community
Able to speak and understand English
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who commenced anti-depressants and/or anxiolytics in the past 3 months or have had a clinically significant change in this medication in the last 3 months;
Deafness.

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)
A computer-generated random sequence available to the off-site trial statistician will be used to produce randomized allocation slips using a randomized permuted block design in order to maintain approximately balanced randomization throughout the trial. These slips will be sealed in opaque, numbered envelopes and provided to the therapists providing intervention and placebo programs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization with computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4119 0
3050
Recruitment postcode(s) [2] 4120 0
3084
Recruitment postcode(s) [3] 4121 0
3181
Recruitment postcode(s) [4] 4996 0
3660
Recruitment postcode(s) [5] 4997 0
3450
Recruitment postcode(s) [6] 4998 0
3171
Recruitment postcode(s) [7] 4999 0
3166
Recruitment postcode(s) [8] 5000 0
3199
Recruitment postcode(s) [9] 5001 0
3044

Funding & Sponsors
Funding source category [1] 267269 0
Charities/Societies/Foundations
Name [1] 267269 0
BeyondBlue
Country [1] 267269 0
Australia
Primary sponsor type
University
Name
National Ageing Research Institute, Melbourne University
Address
PO Box 2127
Royal Melbourne Hospital
Victoria 3050
Country
Australia
Secondary sponsor category [1] 266329 0
Charities/Societies/Foundations
Name [1] 266329 0
BeyondBlue
Address [1] 266329 0
PO Box 6100
Hawthorn West
Victoria 3122
Country [1] 266329 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269270 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 269270 0
Ethics committee country [1] 269270 0
Australia
Date submitted for ethics approval [1] 269270 0
Approval date [1] 269270 0
26/09/2011
Ethics approval number [1] 269270 0
2011.140
Ethics committee name [2] 286685 0
Alfred Health Human Research Ethics Committee
Ethics committee address [2] 286685 0
Ethics committee country [2] 286685 0
Australia
Date submitted for ethics approval [2] 286685 0
Approval date [2] 286685 0
Ethics approval number [2] 286685 0
1/11/0304

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

Contacts
Principal investigator
Name 32760 0
Address 32760 0
Country 32760 0
Phone 32760 0
Fax 32760 0
Email 32760 0
Contact person for public queries
Name 16007 0
Colleen Doyle
Address 16007 0
National Ageing Research Institute
34-54 Poplar Rd
Parkville
Victoria 3052
Country 16007 0
Australia
Phone 16007 0
+61 3 8387 2169
Fax 16007 0
+61 3 9387 4030
Email 16007 0
[email protected]
Contact person for scientific queries
Name 6935 0
Colleen Doyle
Address 6935 0
National Ageing Research Institute
34-54 Poplar Rd
Parkville
Victoria 3052
Country 6935 0
Australia
Phone 6935 0
+61 3 8387 2169
Fax 6935 0
+61 3 9387 4030
Email 6935 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for a randomized controlled trial of telephone-delivered cognitive behavior therapy compared with befriending for treating depression and anxiety in older adults with COPD.2016https://dx.doi.org/10.2147/COPD.S100859
N.B. These documents automatically identified may not have been verified by the study sponsor.