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Trial registered on ANZCTR


Registration number
ACTRN12609000249257
Ethics application status
Approved
Date submitted
22/04/2009
Date registered
12/05/2009
Date last updated
6/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Youth e-therapy – Evaluation of a computerised cognitive behavioural therapy (CCBT) self-help programme for adolescents with mild to moderate depression
Scientific title
Youth e-therapy - Evaluation of a computerised cognitive behavioural therapy self-help programme for adolescents with mild to moderate depression
Secondary ID [1] 252834 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescents aged 12-19 with mild to moderate depressive symptoms 4324 0
Condition category
Condition code
Mental Health 4940 4940 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be invited to complete a computer-administered self-directed programme (CCBT) over 4-8 weeks under minimal supervision from a health professional in primary care setting/school guidance counselling/youth one stop shop.

The computer-administered self-directed programme is based on Cogntive Beahvioural Therapy (CBT) and consists of 7 modules each taking approximately 30 minutes to complete. The programme is steeped in a 3D fantasy game with challenges and puzzles, as well as information about ways of managing mood. Participants are encouraged to complete the 7 modules over a period of 4-8 weeks (in total about 4 hours). Content-specific challenges are set at the end of each module and reviewed at the beginnign of each new module. Participants can complete the programme at school/health clinic or take it home. The programme is accompanied by a printed Notebook where the participants can take notes and track their progress. The overall duration will be determined on a case by case basis.
Intervention code [1] 4399 0
Treatment: Other
Comparator / control treatment
Participants will receive treatment as usual (TAU) as provided by health professionals in a primary care setting/school guidance counselling/youth health clinic.

Treatement as usual will differ on a case-by-case. It is likely to include psychotherapy, group counselling, individual counselling and psychoeducation, etc and may include other support. The detailed descripton of treatment as usual will be collected from each clinician at the end of the treatment.
Control group
Active

Outcomes
Primary outcome [1] 5440 0
The primary outcome measure is the change in depressive symptoms after completion of 4-8 weeks treatment compared with baseline as measured by the Child Depression Rating Scale Revised( CDRS-R) (a clinician based assessment)
Timepoint [1] 5440 0
Baseline; Month 2 (post-intervention assessment); Month 5 (ie:3 month follow up) follow up assessment
Secondary outcome [1] 241931 0
Depressive symptoms as rated by the participant using the Reynolds Adolescent Rating Scale (RADS-2);
Timepoint [1] 241931 0
Baseline; Month 2 (post-intervention assessment); Month 5 (ie:3 month follow up) follow up assessment
Secondary outcome [2] 241932 0
Mood and Feelings Questionnaire (MFQ) long form;
Timepoint [2] 241932 0
Baseline; Month 2 (post-intervention assessment); Month 5 (ie:3 month follow up) follow up assessment
Secondary outcome [3] 241933 0
Quality of life as measured by the Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) self rating scale;
Timepoint [3] 241933 0
Baseline; Month 2 (post-intervention assessment); Month 5 (ie:3 month follow up) follow up assessment
Secondary outcome [4] 241934 0
Clinical Global Impression as rated by the clinician;
Timepoint [4] 241934 0
Month 2 (post-intervention assessment); Month 5 (ie:3 month follow up) follow up assessment
Secondary outcome [5] 241935 0
Anxiety symptoms as measured by the Spence Anxiety self rating scale;
Timepoint [5] 241935 0
Baseline; Month 2 (post-intervention assessment); Month 5 (ie:3 month follow up) follow up assessment
Secondary outcome [6] 241936 0
Hopelessness as measured by the Kazdin Hopelessness (HPLS) self rating scale;
Timepoint [6] 241936 0
Baseline; Month 2 (post-intervention assessment); Month 5 (ie:3 month follow up) follow up assessment
Secondary outcome [7] 241937 0
Satisfaction with the intervention as rated by the participant
Timepoint [7] 241937 0
Month 1 during the intervention; Month 2 (post-intervention assessment); Month 5 (ie:3 month follow up) follow up assessment

Eligibility
Key inclusion criteria
Adolescents will be eligible for inclusion in the trial if:
1. They are experiencing mild to moderate depressive symptoms (as determined by the provider and ideally backed by a standardised assessment tool e.g. depression screening questions or Patient Health Questionnarie ( PHQ-9) with scores of 10-19 inclusive and CDRS-R with t-score of 55-84)
2. They are 12 to 19 years of age on the day of consent
3. They are able to provide written consent. If under the age of 16 on the day of consent parental consent is to be obtained in addition
4. They attend a school/Primary Health Organisation (PHO)/Youth clinic which is a study site
5. They have a reasonable English language ability (minimum of 1 year of schooling in English)
6. They have access to a computer to use the CCBT
Minimum age
12 Years
Maximum age
19 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adolescents will be ineligible for inclusion in the trial if:
1.They score 7 on item 12 and 5 or higher on item 13 on CDRS-R ;
2. They score less than 54 (t-score) on CDRS-R (i.e. have no or minimal symptoms of depression);
3. They have severe depression (i.e: t-score of 85 or higher on CDRS-R or be judged by clinican that self-help computer programme alone is unlikey to be adequate) or high suicide/self-harm risk;
4.They have an intellectual disability or physical limitations that would result in them not being able to use the computer programme;
5. If they have any other major mental health disorder where the primary focus is not depression;
6. If they are have received within the last 3 months, or are already receiving CBT, interpersonal therapy (IPT) or antidepressant medication;

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)
1. Completion of baseline data with participants by research assistant
2. Local investigator / clinician open sealed randomisation envelopes and find out which group participants will be randomised to.
3.Participants are allocated to either Treatment as Usual (TAU) or CCBT.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sequence of numbers is generated by our biostatistician. The treatment allocation instructions are placed in opaque and sealed envelopes with the corresponding randomisation number on the envelope. The list of numbers is kept separate from the research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1571 0
New Zealand
State/province [1] 1571 0

Funding & Sponsors
Funding source category [1] 4669 0
Government body
Name [1] 4669 0
Ministry of Health
Address [1] 4669 0
PO Box 5013,
Wellington 6011
Country [1] 4669 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Department of Psychological Medicine,
Faculty of Medical and Health Science, the University of Auckland,
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 4215 0
None
Name [1] 4215 0
Address [1] 4215 0
Country [1] 4215 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6707 0
Multi-region Ethics committee
Ethics committee address [1] 6707 0
Ministry of Health Po Box 5013 Wellington 6011
Ethics committee country [1] 6707 0
New Zealand
Date submitted for ethics approval [1] 6707 0
Approval date [1] 6707 0
08/03/2009
Ethics approval number [1] 6707 0
MEC/08/12/159

Summary
Brief summary
Depression is a major health issue amongst adolescents in New Zealand with rates of 4-8% at the age of 15 rising rapidly to 17-18% by the age of 18. The effect of depressive disorder in young people is pervasive and affects not only function but overall development. Treatment options include cognitive behavioural therapy (CBT), interpersonal psychotherapy (IPT), and anti-depressants for serious depressive disorder. Workforce strategies mean that CBT and IPT are often unavailable. This study is to evaluate self-administered CBT that is computer-based. This self-help treatment is a form of therapy that has several advantages over traditional therapist-administered help in that patients can go through the programme at their own pace. It is less costly to administer, easily accessible, and may not carry the stigma often associated with seeking mental health treatment. This study will compare the efficacy of computerized CBT (CCBT) with the usual therapy in adolescents with mild to moderate depression. Study participants will be assessed after a 2 month treatment period and again 3 months after completion of therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29283 0
Address 29283 0
Country 29283 0
Phone 29283 0
Fax 29283 0
Email 29283 0
Contact person for public queries
Name 12530 0
Sally Merry
Address 12530 0
Department of Psychological Medicine
Faculty of Medical and Health Science University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 12530 0
New Zealand
Phone 12530 0
+64 9 3737599 ext 86981
Fax 12530 0
+64 9 3737013
Email 12530 0
s.merry@auckland.ac.nz
Contact person for scientific queries
Name 3458 0
Sally Merry
Address 3458 0
Department of Psychological Medicine
Faculty of Medical and Health Science University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 3458 0
New Zealand
Phone 3458 0
+64 9 3737599 ext 86981
Fax 3458 0
+64 9 3737013
Email 3458 0
s.merry@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary