Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000723684
Ethics application status
Approved
Date submitted
20/09/2005
Date registered
9/11/2005
Date last updated
15/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Psychotherapy for depression: a comparison of two cognitive treatments
Scientific title
A randomised trial of cognitive behaviour therapy and schema focused therapy in major depression to reduce depressive symptoms over six months.
Secondary ID [1] 290420 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 874 0
Condition category
Condition code
Mental Health 942 942 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behaviour Therapy (CBT) versus Schema Focused Therapy (SFT).
Duration: 12 months.
Intervention code [1] 657 0
Treatment: Other
Intervention code [2] 296254 0
Behaviour
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1238 0
To test the hypothesis that SFT is superior to CBT in achieving sustained change in depression as judged by independent clinician ratings (MADRS)
Timepoint [1] 1238 0
Over the last 6 months of treatment.
Secondary outcome [1] 2256 0
i) To compare SFT with CBT on i) Outcomes
Timepoint [1] 2256 0
At the end of the weekly sessions.
Secondary outcome [2] 2257 0
ii) Sustained change on a self-report measure (BDI-II) of depressive symptoms
Timepoint [2] 2257 0
Secondary outcome [3] 2258 0
iii) Remission (MADRS & BDI-II<10 for 2 weeks) and recovery (MADRS & BDI-II<10 for 8 weeks).
Timepoint [3] 2258 0
At the end of weekly sessions and during the following monthly sessions.

Eligibility
Key inclusion criteria
Individuals currently experiencing a major depressive episode (DSM-IV). All people accepted into the study need to be free of any centrally acting drugs (except an occasional hypnotic or the oral contraceptive) and who are able to be safely managed with outpatient psychotherapy.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permutated block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
20/10/2003
Actual
6/11/2003
Date of last participant enrolment
Anticipated
Actual
10/09/2008
Date of last data collection
Anticipated
Actual
4/11/2013
Sample size
Target
150
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 235 0
New Zealand
State/province [1] 235 0
Christchurch, Canterbury, New Zealand

Funding & Sponsors
Funding source category [1] 1040 0
Government body
Name [1] 1040 0
Lottery Grants Board
Country [1] 1040 0
New Zealand
Primary sponsor type
Government body
Name
Lottery Grants Board
Address
Lottery Health Research Committee
c/- Local Government and Community Branch
Department of Internal Affairs
PO Box 805
WELLINGTON 6140
Country
New Zealand
Secondary sponsor category [1] 902 0
None
Name [1] 902 0
Not applicable
Address [1] 902 0
Country [1] 902 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2340 0
Canterbury Ethics Committee
Ethics committee address [1] 2340 0
Ethics committee country [1] 2340 0
New Zealand
Date submitted for ethics approval [1] 2340 0
Approval date [1] 2340 0
19/06/2003
Ethics approval number [1] 2340 0

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

Contacts
Principal investigator
Name 36287 0
Prof Janet Carter
Address 36287 0
Psychology Department
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 36287 0
New Zealand
Phone 36287 0
+6433694210
Fax 36287 0
+64 3 3642181
Email 36287 0
janet.carter@canterbury.ac.nz
Contact person for public queries
Name 9846 0
Prof Janet Carter
Address 9846 0
Psychology Department
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 9846 0
New Zealand
Phone 9846 0
+6433694210
Fax 9846 0
+64 3 3642181
Email 9846 0
janet.carter@canterbury.ac.nz
Contact person for scientific queries
Name 774 0
Prof. Janet Carter
Address 774 0
Psychology Department
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 774 0
New Zealand
Phone 774 0
+6433694210
Fax 774 0
+64 3 3642181
Email 774 0
janet.carter@canterbury.ac.nz

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
Dimensions AIClinical factors and early life experiences associated with therapeutic alliance development in treatment for depression or binge eating2023https://doi.org/10.1080/10503307.2023.2191800
N.B. These documents automatically identified may not have been verified by the study sponsor.