Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001106820
Ethics application status
Approved
Date submitted
12/10/2012
Date registered
17/10/2012
Date last updated
17/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Utilizing the Internet to deliver mental health self-help interventions to senior high-school students.
Scientific title
The effect of Internet-based self-help interventions for depression in senior high-school students
Secondary ID [1] 281382 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 287611 0
Personality 287612 0
Self-esteem 287613 0
Self-efficacy 287614 0
Condition category
Condition code
Mental Health 287943 287943 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MoodGYM is a Internet-based self-help program aimed at preventing and treating depression. It is based on the principles of cognitive behavioural therapy. It is developed at the Centre for Mental Health Research at Australian National University.

Intervention arm 1: MoodGYM , 1x1 hour module per week for 5 weeks.

Intervention arm 2: MoodGYM with standard weekly e-mail reminders, 1x1 hour module per week for 5 weeks.

Intervention arm 3: MoodGYM with tailored weekly e-mail reminders, 1x1 hour module per week for 5 weeks.

Control group arm 4: No intervention.
Intervention code [1] 285855 0
Prevention
Intervention code [2] 285880 0
Treatment: Other
Comparator / control treatment
The control group will be offered the intervention after 6-7 weeks (after post-test).
Control group
Active

Outcomes
Primary outcome [1] 288151 0
Depression is measured using the Centre for Epidemiological Studies Depression Scale (CES-D).
Timepoint [1] 288151 0
Pre and post intervention at 6 weeks.
Primary outcome [2] 288152 0
Personality is measured using The Junior Temperament and Character Inventory (JTCI).
Timepoint [2] 288152 0
Pre intervention.
Secondary outcome [1] 299517 0
Self-efficacy is measured using General Self-Efficacy Scale
Timepoint [1] 299517 0
Pre and post intervention at 6 weeks.
Secondary outcome [2] 299518 0
Self-esteem is measured using Rosenberg Self-esteem scale.
Timepoint [2] 299518 0
Pre and post intervention at 6 weeks.

Eligibility
Key inclusion criteria
Senior high school students. No other criteria.
Minimum age
15 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment outside Australia
Country [1] 4596 0
Norway
State/province [1] 4596 0

Funding & Sponsors
Funding source category [1] 286134 0
Government body
Name [1] 286134 0
Norwegian Research Council
Country [1] 286134 0
Norway
Primary sponsor type
Individual
Name
Professor Martin Eisemann
Address
University of Tromsoe, Department of Psychology,
Huginbakken 32, 9034 Tromsoe.
Country
Norway
Secondary sponsor category [1] 284945 0
Individual
Name [1] 284945 0
Professor Knut Waterloo
Address [1] 284945 0
University of Tromsoe, Department of Psychology,
Huginbakken 32, 9034 Tromsoe.
Country [1] 284945 0
Norway
Other collaborator category [1] 277120 0
University
Name [1] 277120 0
Centre for mental health research, Australian National University
Address [1] 277120 0
Centre for Mental Health Research
Building 63
The Australian National University
Canberra ACT 0200
AUSTRALIA
Country [1] 277120 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288181 0
Reginal Ethics Committee, Northern Norway
Ethics committee address [1] 288181 0
Ethics committee country [1] 288181 0
Norway
Date submitted for ethics approval [1] 288181 0
01/10/2008
Approval date [1] 288181 0
09/10/2008
Ethics approval number [1] 288181 0
200605094-7/KST01/400

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

Contacts
Principal investigator
Name 34820 0
Address 34820 0
Country 34820 0
Phone 34820 0
Fax 34820 0
Email 34820 0
Contact person for public queries
Name 18067 0
Professor Martin Eisemann
Address 18067 0
University of Tromsoe
Department of Psychology
Huginbakken 32
9037 Tromsoe
Country 18067 0
Norway
Phone 18067 0
+47 77646279
Fax 18067 0
Email 18067 0
[email protected]
Contact person for scientific queries
Name 8995 0
Professor Martin Eisemann
Address 8995 0
University of Tromsoe
Department of Psychology
Huginbakken 32
9037 Tromsoe
Country 8995 0
Norway
Phone 8995 0
+47 77646279
Fax 8995 0
Email 8995 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.