Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000563965
Ethics application status
Approved
Date submitted
31/05/2011
Date registered
2/06/2011
Date last updated
14/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Online vs. Face-to-Face Cognitive-Behavioural Therapy for Depression -a Randomized Controlled Trial
Scientific title
In male and female adults suffering from depression, is online cognitive behavioural therapy more effective than face-to-face treatment in terms of clinical outcomes and working alliance?
Secondary ID [1] 262278 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 267980 0
Condition category
Condition code
Mental Health 268112 268112 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
cognitive behavioural therapy, duration 8 weeks, online setting vs. face-to-face, participants complete two modules per week for 8 weeks. Each module should take about 45 minutes to complete.
Intervention code [1] 266670 0
Behaviour
Intervention code [2] 266677 0
Treatment: Other
Comparator / control treatment
Standard treatment (treatment as usual – cognitive behavioural therapy, face-to-face), participants attend two 45 minute session per week for 8 weeks, the treatment is individual (therapists answer each patient individually)
Control group
Active

Outcomes
Primary outcome [1] 266861 0
mean Beck depression score
Timepoint [1] 266861 0
at baseline and at 3, 6, and 12 months after intervention commencement
Secondary outcome [1] 276514 0
mean of Working Alliance Inventory
Timepoint [1] 276514 0
at mid-treatment and post-treatment
Secondary outcome [2] 276515 0
mean of Trust in Physician Scale
Timepoint [2] 276515 0
at mid-treatment and post-treatment
Secondary outcome [3] 276516 0
mean of Social Presence Scale
Timepoint [3] 276516 0
at mid-treatment and post-treatment

Eligibility
Key inclusion criteria
Score greater than or equal to 12 on the Beck Depression Inventory (BDI)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
current substance abuse or dependence
psychotic symptoms
high risk of suicide
currently receiving treatment
illiterate in German

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)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomisation table created by computer software (computerised sequence generator)
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
Active, not recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3604 0
Switzerland
State/province [1] 3604 0
Zurich

Funding & Sponsors
Funding source category [1] 267162 0
Charities/Societies/Foundations
Name [1] 267162 0
Werner Selo Foundation
Country [1] 267162 0
Switzerland
Primary sponsor type
University
Name
University of Zurich
Address
Department of Psychology
Psychopathology
Binzmuehlestr. 14/17
8050 Zurich
Country
Switzerland
Secondary sponsor category [1] 266236 0
None
Name [1] 266236 0
Address [1] 266236 0
Country [1] 266236 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269152 0
Kantonale Ethikkommission des Kantons Zuerich
Ethics committee address [1] 269152 0
Ethics committee country [1] 269152 0
Switzerland
Date submitted for ethics approval [1] 269152 0
Approval date [1] 269152 0
21/07/2009
Ethics approval number [1] 269152 0
E-71/2008

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

Contacts
Principal investigator
Name 32675 0
Address 32675 0
Country 32675 0
Phone 32675 0
Fax 32675 0
Email 32675 0
Contact person for public queries
Name 15922 0
Dr. phil. Birgit Wagner
Address 15922 0
Universitaetsklinikum Leipzig
Department fuer Psychische Gesundheit
Klinik und Poliklinik fuer Psychosomatische Medizin und Psychotherapie
Semmelweisstr. 10
04103 Leipzig
Country 15922 0
Germany
Phone 15922 0
+49-341-9718861
Fax 15922 0
Email 15922 0
birgit.wagner@medizin.uni-leipzig.de
Contact person for scientific queries
Name 6850 0
Dr. phil. Birgit Wagner
Address 6850 0
Universitaetsklinikum Leipzig
Department fuer Psychische Gesundheit
Klinik und Poliklinik fuer Psychosomatische Medizin und Psychotherapie
Semmelweisstr. 10
04103 Leipzig
Country 6850 0
Germany
Phone 6850 0
+49-341-9718861
Fax 6850 0
Email 6850 0
birgit.wagner@medizin.uni-leipzig.de

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.