Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001166763
Ethics application status
Approved
Date submitted
16/10/2013
Date registered
23/10/2013
Date last updated
3/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of psychological treatments for depression following traumatic brain injury
Scientific title
Evaluation of behavioural activation therapy for the treatment of depression following traumatic brain injury
Secondary ID [1] 283407 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 290316 0
Major Depressive Disorder 290317 0
Condition category
Condition code
Mental Health 290715 290715 0 0
Depression
Injuries and Accidents 290716 290716 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behavioural activation therapy. A behaviourally based intervention for depression which involves establishing new patterns of behaviour.

Therapy is administered in face-to-face sessions held in professional suites.

Participants attend a weekly session of one-hour duration and undertake activity assignments over a 12 week course.

Participants undertake activity assignments in three treatment phases. The phases related to goals in the areas of (1) physical fitness, (2) purposeful domestic activities and (3) vocational and/or social activities.

Treatment is based on "Lejuez, C.W., et al. (2010). Ten Year Revision of the Brief Behavioral Activation Treatment for Depression (BATD): Revised Treatment Manual (BATD-R)." The BATD-R includes a treatment adherence checklist. The treatment sessions will be videorecorded and a researcher will rate adherence to the treatment manual
Intervention code [1] 288131 0
Behaviour
Intervention code [2] 288144 0
Treatment: Other
Comparator / control treatment
Multiple baseline design. The commencement of treatment is randomised to occur within 1-2 weeks.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290717 0
Frequency of engagement in activities relevant to social/vocational, exercise and ADL goals. This is assessed by collecting logs of activities and behaviours performed by the participants. Logs are collected by the participants themselves, and by informants such as family members, carers and treatment team members.
Timepoint [1] 290717 0
Continuous measurement throughout baseline and treatment phases (expected to be 12 weeks)
Secondary outcome [1] 305091 0
Scores on the Satisfaction with Life Scale
Timepoint [1] 305091 0
Measurement at each phase of the study (i.e. at baseline and during each of three treatment phases, and at conclusion). This is measured at the beginning of the study and at the end of each phase (i.e. beginning and end of baseline phase, and at the end of each treatment phase)

Eligibility
Key inclusion criteria
Adults who have a history of Acquired Brain Injury and a current diagnosis of Major Depressive Disorder
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Undergoing analogous treatments concurrently. Undergoing pharmacological treatment which is not stabilised.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised order of commencement of study. Randomisation was by a computer generated sequence conducted by an author not involved in delivering treatment.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Structured Visual Analysis
Data analysis using Tau-U

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/10/2013
Actual
24/10/2013
Date of last participant enrolment
Anticipated
Actual
3/01/2014
Date of last data collection
Anticipated
Actual
30/06/2014
Sample size
Target
2
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7477 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 288131 0
Self funded/Unfunded
Name [1] 288131 0
Paul Gertler
PhD Candidate
Country [1] 288131 0
Australia
Primary sponsor type
University
Name
Moving Ahead: Centre of Research Excellence in Brain Recovery at the University of NSW
Address
School of Psychology
University of New South Wales,
High Street,
Kensington NSW, 2052
Country
Australia
Secondary sponsor category [1] 286850 0
None
Name [1] 286850 0
Address [1] 286850 0
Country [1] 286850 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290045 0
Human Research Ethics Committee
Ethics committee address [1] 290045 0
Margaret Telfer K07
University of Sydney NSW 2006
Ethics committee country [1] 290045 0
Australia
Date submitted for ethics approval [1] 290045 0
Approval date [1] 290045 0
17/07/2012
Ethics approval number [1] 290045 0
14939

Summary
Brief summary
This project is part of a larger body of work evaluating non-pharmacological interventions for depression following traumatic brain injury (TBI). In this project we intend to evaluate specific psychological strategies by applying a single-case experimental design (SCED), also referred to as an n-of-1 trial. The participants will be two people with a history of TBI who are referred to a clinical psychologist in private practice. These individuals will be subject to standardized forms of psychological assessment during a baseline phase. They will then undergo a comprehensive psychological intervention following treatment protocols developed with non-TBI patients. Following this time they will both be assessed during a follow up phase.
Trial website
Trial related presentations / publications
2015 NR-SIG conference at Daydream Island
Public notes

Contacts
Principal investigator
Name 43686 0
Prof Robyn L. Tate
Address 43686 0
Rehabilitation Studies Unit
Northern Clinical School
School of Medicine,
University of Sydney
Care of: - Royal Rehabilitation Centre Sydney
Morrison Road, Putney
PO Box 6, RYDE NSW 1680
Country 43686 0
Australia
Phone 43686 0
+61 2 98089236
Fax 43686 0
Email 43686 0
[email protected]
Contact person for public queries
Name 43687 0
Mr Paul Gertler
Address 43687 0
Rehabilitation Studies Unit
Northern Clinical School
School of Medicine
University of Sydney

Address for correspondence:
Suite 45, Level 9
193 Macquarie Street
Sydney NSW 2000
Country 43687 0
Australia
Phone 43687 0
+61 2 9221 2763
Fax 43687 0
Email 43687 0
[email protected]
Contact person for scientific queries
Name 43688 0
Mr Paul Gertler
Address 43688 0
Rehabilitation Studies Unit
Northern Clinical School
School of Medicine
University of Sydney

Address for correspondence:
Suite 45, Level 9
193 Macquarie Street
Sydney NSW 2000
Country 43688 0
Australia
Phone 43688 0
+61 2 9221 2763
Fax 43688 0
Email 43688 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
No additional documents have been identified.