Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000142538
Ethics application status
Approved
Date submitted
26/04/2006
Date registered
26/04/2006
Date last updated
26/04/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Helping teenagers deal with depression - Project Journey.
Scientific title
Computerised delivery of a Cognitive-Behavioural Therapy (CBT)-based guided self-help intervention for the treatment of depression in adolescents: development and pilot study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild-to-moderate depression 1111 0
Condition category
Condition code
Mental Health 1191 1191 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Half of the participants are completing a computer resource with a CBT-based guided self-help intervention (the study intervention). Programme consists of 7 modules requiring sequential completion within 4-8 weeks under minimal supervision from a school guidance counsellor/clinician.
Intervention code [1] 997 0
Treatment: Other
Comparator / control treatment
The second half are completing a matching computer resource with psychoeducation/self-care messages commonly used with depressed adolescents (used as a control intervention). Programme consists of 7 modules requiring sequential completion within 4-8 weeks under minimal supervision from a school guidance counsellor/clinician.
Control group
Active

Outcomes
Primary outcome [1] 1605 0
Reduction in depression. Two measures are used: Clinician-rated Child Depression Rating Scale-Revised and self-rated Reynold's Adolescent Depression Scale-2.
Timepoint [1] 1605 0
Assessment occurs prior to randomisation, within 7 days of completing the resource and at a 4-week follow-up.
Secondary outcome [1] 2905 0
Improved quality of life as assessed by Pediatric Quality of Life (PedsQL).
Timepoint [1] 2905 0
Assessment occurs prior to randomisation, within 7 days of completing the resource and at a 4-week follow-up.
Secondary outcome [2] 2906 0
Improved coping style as measured by Adolescent Coping Scale (ACS).
Timepoint [2] 2906 0
Assessment occurs prior to randomisation, within 7 days of completing the resource and at a 4-week follow-up.

Eligibility
Key inclusion criteria
Presentation to school guidance counsellor/clinician for low mood/depression. English language competency and computer literacy.
Minimum age
13 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
High risk of sucidal/self-harm behaviour; currently receiving psychological treatment/counselling; learning disability.

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)
Allocation schedule randomly generated and placed in sequentially numbered, sealed, opaque envelopes. At each site the counsellor/clinician allocated participants to a group by opening the next-numbered envelope. No block randomisation or stratification is being used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number function in excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a pilot/feasibility study that first involved development of the computerised resources based on a theoretical framework and consultation with young people and experts. In addition to the RCT, an exit survey of satisfaction with treatment and some in-depth interviews with participants and counsellors/clinicians will be conducted.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 304 0
New Zealand
State/province [1] 304 0

Funding & Sponsors
Funding source category [1] 1302 0
Charities/Societies/Foundations
Name [1] 1302 0
Oakley Mental Health Research Foundation
Country [1] 1302 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 1150 0
None
Name [1] 1150 0
Nil
Address [1] 1150 0
Country [1] 1150 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2630 0
Northern X Regional Ethics Committee-Selected secondary schools in Auckland
Ethics committee address [1] 2630 0
Ethics committee country [1] 2630 0
New Zealand
Date submitted for ethics approval [1] 2630 0
Approval date [1] 2630 0
Ethics approval number [1] 2630 0
NTX/04/12/001
Ethics committee name [2] 2631 0
Northern X Regional Ethics Committee-New Zealand and Child and Adolescent Mental Health agencies
Ethics committee address [2] 2631 0
Ethics committee country [2] 2631 0
New Zealand
Date submitted for ethics approval [2] 2631 0
Approval date [2] 2631 0
Ethics approval number [2] 2631 0
NTX/04/12/001

Summary
Brief summary
Depressive disorder in adolescents is common and largely untreated. Cognitive-behavioural therapy has been found to be effective in treating mild to moderate depression. Being a structured therapy it lends itself very well to a computer medium to be used as a self-help programme. As young people are frequent users of modern technologies, utilising computers in the design of health interventions seems a reasonable choice. However, to date no computerised CBT programmes have specifically targeted adolescents. Computerised intervention has the potential to be an inexpensive, low risk and widely available depression treatment. This study pilots two self-developed computer resources (comapring CBT-based programme with a control psychoeducation/self-care message) to treat mild-to-moderate depression in adolescents attending secondary schools. The aim of the study is to assess the resource's feasibility, acceptability and appeal with a view of refining it and carrying out a larger trial in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35535 0
Address 35535 0
Country 35535 0
Phone 35535 0
Fax 35535 0
Email 35535 0
Contact person for public queries
Name 10186 0
Karolina Stasiak (PhD candidate)
Address 10186 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Grafton Auckland 1
Country 10186 0
New Zealand
Phone 10186 0
+64 9 3737599 ext. 83890
Fax 10186 0
+64 9 3737493
Email 10186 0
k.stasiak@auckland.ac.nz
Contact person for scientific queries
Name 1114 0
Karolina Stasiak (PhD candidate)
Address 1114 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Grafton Auckland 1
Country 1114 0
New Zealand
Phone 1114 0
+64 9 3737599 ext. 83890
Fax 1114 0
Email 1114 0
k.stasiak@auckland.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
No additional documents have been identified.