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Trial registered on ANZCTR


Registration number
ACTRN12611000574943
Ethics application status
Approved
Date submitted
2/06/2011
Date registered
3/06/2011
Date last updated
3/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of Anxiety and Depression in Adult Brain Tumour Patients
Scientific title
Psychological Treatment of Anxiety and Depression in Adult Brain Tumour Patients
Secondary ID [1] 262299 0
Nil
Universal Trial Number (UTN)
U1111-1121-9222
Trial acronym
BABT Program for distressed brain tumour patients
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary brain tumours 268007 0
Depression 268005 0
Anxiety 268006 0
Condition category
Condition code
Cancer 268137 268137 0 0
Brain
Mental Health 268136 268136 0 0
Depression
Mental Health 268144 268144 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to investigate whether the psychological therapy program, titled the ‘Behavioural and Acceptance Based Therapy (BABT)’ program is useful in helping individuals reduce their distress (including anxiety and depressive symptoms) resulting from their brain tumour experience, as well as improve their overall quality of life.

The BABT intervention will be conducted in an individual face-to-face format and will consist of six consecutive
weekly meetings, 1.5 hours each, plus two follow-up/ booster sessions conducted at fortnightly intervals. The program will be administered by qualified psychologists.
Intervention code [1] 266699 0
Treatment: Other
Intervention code [2] 266690 0
Lifestyle
Intervention code [3] 266689 0
Behaviour
Comparator / control treatment
The BABT program will be compared to a Wait-List control (WLC).

Participants in the WLC condition will be offered treatment after 3 months (12 weeks) following their initial baseline assessment.
Control group
Active

Outcomes
Primary outcome [1] 266883 0
Depression: Beck Depression Inventory [BDI-II], reduction of sample mean scores to non-clinical levels (< 14 points)
Timepoint [1] 266883 0
Baseline, end of therapy (10 weeks after intervention commencement), 1-month and 3-months follow-up (i.e, 14 weeks and 26 weeks after intervention commencement).
Primary outcome [2] 266885 0
Acceptance: Acceptance and Action Questionnaire, reduction of mean scales scores in experiential avoidance symptoms and improvements in acceptance.
Timepoint [2] 266885 0
Baseline, end of therapy (10 weeks after intervention commencement), 1-month and 3-months follow-up (i.e, 14 weeks and 26 weeks after intervention commencement).
Primary outcome [3] 266884 0
Brain tumour related stress: Impact of Events Scaled- Revised [IES-R], reduction of sample mean scores to scores < 33.
Timepoint [3] 266884 0
Baseline, end of therapy (10 weeks after intervention commencement), 1-month and 3-months follow-up (i.e, 14 weeks and 26 weeks after intervention commencement).
Secondary outcome [1] 276563 0
Anxiety: State Trait Anxiety Scale (STAI), reduction of mean scales scores to non-clinical levels.
Timepoint [1] 276563 0
Baseline, end of therapy (10 weeks after intervention commencement), 1-month and 3-months follow-up (i.e, 14 weeks and 26 weeks after intervention commencement).
Secondary outcome [2] 276562 0
Quality of Life: FACIT - General and Brain tumour scales. Expected improvements of mean scores to non-clinical levels
Timepoint [2] 276562 0
Baseline, end of therapy (10 weeks after intervention commencement), 1-month and 3-months follow-up (i.e, 14 weeks and 26 weeks after intervention commencement).
Secondary outcome [3] 276564 0
Coping Strategies: BCOPE
Timepoint [3] 276564 0
Baseline, end of therapy (10 weeks after intervention commencement), 1-month and 3-months follow-up (i.e, 14 weeks and 26 weeks after intervention commencement).

Eligibility
Key inclusion criteria
1) diagnosed with a primary low - medium grade BT (i.e., at least 12 month prognosis);
2) completion of all acute medical treatments at time of referral;
3) reporting at least moderate (sub-clinical or clinical) levels of anxiety or depressive symptoms (which will be screened at initial assessment);
4) aged 18 to 80 years;
5) able to speak, read and write basic English; and
5) medically fit to respond to the assessment and intervention procedures (i.e., able to sit for 1 hour at a time).
6) In the event a participant has been prescribed and currently using medication for psychological problems (notably anti-depressants or anxiolytics), they will be required to be on a stable dosage for at least 4 weeks prior to the initial/baseline assessment. If they are deemed suitable for the therapy program after the screening assessment, patients taking antidepressants or anxiolytics will be required to remain on a stable dose throughout the course of the BABT program.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Presence of severe cognitive and language deficits (defined as score < 1.96 SD below mean) that will be assessed via a neuropsychological assessment battery;
2) current history of significant alcohol/ drug abuse or psychosis;
3) current suicidal ideation (will be referred to acute crisis team); and
4) currently undergoing psychiatric treatment for mental illness.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
In the first instance, medical staff at the treatment hospital will advise potentially eligible patients about the study. If patient provides verbal consent to be contacted by the research team, the research team will follow-up and provide patient with study details. Interested participants will be invited to attend an initial/screening assessment session. Following screening assessment, eligible participants will be randomly allocated to receive the BABT program immediately or placed on wait-list control via random number table. However allocation of participants to active vs WLC conditions will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4066 0
2109

Funding & Sponsors
Funding source category [1] 267177 0
University
Name [1] 267177 0
Macquarie University Safety Net Scheme
Country [1] 267177 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University
North Ryde
Sydney, NSW 2109
Country
Australia
Secondary sponsor category [1] 266251 0
Hospital
Name [1] 266251 0
Prince of Wales Hospital
Address [1] 266251 0
Prince of Wales Hospital
Department of Radiation Oncology
Avoca Street
Randwick, NSW 2031
Country [1] 266251 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269173 0
Macquarie University
Ethics committee address [1] 269173 0
Ethics committee country [1] 269173 0
Australia
Date submitted for ethics approval [1] 269173 0
Approval date [1] 269173 0
10/06/2010
Ethics approval number [1] 269173 0
5201000732
Ethics committee name [2] 269172 0
Macquarie University Human Ethics Committee
Ethics committee address [2] 269172 0
Ethics committee country [2] 269172 0
Australia
Date submitted for ethics approval [2] 269172 0
Approval date [2] 269172 0
22/11/2010
Ethics approval number [2] 269172 0
5201001305

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

Contacts
Principal investigator
Name 32691 0
Address 32691 0
Country 32691 0
Phone 32691 0
Fax 32691 0
Email 32691 0
Contact person for public queries
Name 15938 0
Dr Maria Kangas
Address 15938 0
Macquarie University
Centre for Emotional Health
Department of Psychology
C3A #717
Ryde, NSW 2109
Country 15938 0
Australia
Phone 15938 0
612 9850 8599
Fax 15938 0
Email 15938 0
maria.kangas@mq.edu.au
Contact person for scientific queries
Name 6866 0
Dr Maria Kangas
Address 6866 0
Macquarie University
Centre for Emotional Health
Department of Psychology
C3A #717
Ryde, NSW 2109
Country 6866 0
Australia
Phone 6866 0
612 9850 8599
Fax 6866 0
Email 6866 0
maria.kangas@mq.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.