Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000257066
Ethics application status
Approved
Date submitted
12/03/2010
Date registered
26/03/2010
Date last updated
12/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet-based cognitive therapy in the treatment of patients with depression in general practice
Scientific title
Among adults with mild- to moderate depression, does a 6-weeks Internet-based cognitive behavioral therapy program with minimal therapist contact, compared with waiting list condition reduce symptoms of depression.
Secondary ID [1] 1516 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 256967 0
Condition category
Condition code
Mental Health 257110 257110 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Internet-based cognitive behavior therapy
Brief therapy, 20 minutes once a week for a total of 6 weeks. 5 modules with homework between sessions. Overview of modules: Module 1 - FEELINGS: Why do you feel the way you do; Module 2 - THOUGHTS: Changing the way we think to feel better including help with self-esteem; Module 3 - UNWARPING: Changing Warped Thoughts by Other Methods, Learning to Identify Personal Vulnerabilities, More Help with Self-Esteem; Module 4 - DE-STRESSING: Knowing What Makes You Upset, Learning to Relax; Module 5 - RELATIONSHIPS: investigate relationship problems and how to cope with them.
Intervention code [1] 256144 0
Treatment: Other
Intervention code [2] 256169 0
Behaviour
Comparator / control treatment
waiting list control group, Treatment as usual (TAU).
The wait list control commences the therapy immediately after the intervention group finishes, i.e after 6 weeks.
The treatment as usual means that participants are on a waiting list for treatment and could received usual care by their general practitioners.
Control group
Active

Outcomes
Primary outcome [1] 258005 0
mean Becks depression score
Timepoint [1] 258005 0
at baseline, at 6 weeks, and 6 months after intervention commencement
Secondary outcome [1] 263561 0
relapse rate. This will be assessed by using Beck Depression Inventory (BDI).
Timepoint [1] 263561 0
6 months after intervention commencemen

Eligibility
Key inclusion criteria
Age, mild to moderate symptoms of depression (BDI), access to Internet
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
suicidal ideation, alcoholism, drug abuse, psychosis, current Cognitive Behaviour Therapy (CBT) treatment, individuals who during the last month have begun using or changed dosage of antidepressants

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 randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
21/10/2010
Date of last participant enrolment
Anticipated
Actual
9/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 2539 0
Norway
State/province [1] 2539 0

Funding & Sponsors
Funding source category [1] 256647 0
Government body
Name [1] 256647 0
Norwegian Research Council
Country [1] 256647 0
Norway
Primary sponsor type
University
Name
University of Tromso
Address
Faculty of Health sciences, N-9037 Tromso, Norway
Country
Norway
Secondary sponsor category [1] 255934 0
None
Name [1] 255934 0
Address [1] 255934 0
Country [1] 255934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258671 0
Regional Committees for Medical and Health Research Ethics (REK)
Ethics committee address [1] 258671 0
University of Tromso, Faculty of Health Sciences, N-9037 TROMS0.
Ethics committee country [1] 258671 0
Norway
Date submitted for ethics approval [1] 258671 0
Approval date [1] 258671 0
Ethics approval number [1] 258671 0

Summary
Brief summary
This project is designed to determine if Internet-based cognitive therapy with minimal therapist contact can improve the efficiency of psychologists and general practitioners in the treatment of mild to moderate depression. In addition, the project will allow us to investigate the effect of an Internet-based cognitive behavior therapy intervention in a clinical sample. The primary hypothesis is that the Internet-based program will lead to a larger reduction in depressive symptoms than a wait list control condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30934 0
A/Prof Nils Kolstrup
Address 30934 0
Faculty of Health Sciences, University of Tromso, 9037 Tromso, Norway
Country 30934 0
Norway
Phone 30934 0
+47 776 44000
Fax 30934 0
Email 30934 0
nils.kolstrup@uit.no
Contact person for public queries
Name 14181 0
Nils Kolstrup
Address 14181 0
University of Tromso, Faculty of Health Sciences, N-9037 TROMSO.
Country 14181 0
Norway
Phone 14181 0
+47 77644000
Fax 14181 0
Email 14181 0
nils.kolstrup@uit.no
Contact person for scientific queries
Name 5109 0
Nils Kolstrup
Address 5109 0
University of Tromso, Faculty of Health Sciences, N-9037 TROMSO.
Country 5109 0
Norway
Phone 5109 0
+47 77644000
Fax 5109 0
Email 5109 0
nils.kolstrup@uit.no

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
EmbasePredictors of Response to Web-Based Cognitive Behavioral Therapy With High-Intensity Face-to-Face Therapist Guidance for Depression: A Bayesian Analysis.2015https://dx.doi.org/10.2196/jmir.4351
N.B. These documents automatically identified may not have been verified by the study sponsor.