Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000074099
Ethics application status
Approved
Date submitted
14/12/2009
Date registered
20/01/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of a computerised cognitive behavioural therapy programme for depression among young people who are outside of mainstream education.
Scientific title
The effect of a computerised Cognitive Behavioural Therapy programme on depressive symptoms in young people who have mild to moderate depression and are outside of mainstream education.
Secondary ID [1] 1295 0
nil
Universal Trial Number (UTN)
U1111-1112-8752
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 252386 0
Condition category
Condition code
Mental Health 256568 256568 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Computerised cognitive behavoural therapy (CBT) intervention. Participants are asked to complete 1 or 2 30 minute levels per week; there are 7 levels in total which should be completed within 5 weeks as suits the individual. The topics covered include psycho-education, relaxation techniques, social skills training, activity scheduling, problem solving, recognition and restructing of cognitive disortions, hopefulness and helpseeking.

A crossover study design is used: all participants are screened at baseline and then randomised to treatment now (to be completed over the following 4-5 weeks) or delayed start (start after 5 weeks). All participants are reassessed at 5 weeks (after those randomised to 'start now' have completed the intervention and before those randomised to 'delayed start' begin) and at 10 weeks (after all participants have completed the programme), 50% of participants randomised to 'delayed start' are reassessed at 15 weeks.
Intervention code [1] 255868 0
Treatment: Other
Comparator / control treatment
Delayed treatment.
1.All participants are assessed (assessment 1)
2. Then all participants are randomised to beginning the treatment straight away (group 1) or beginning the treatment after assessment two in 5 weeks time (group 2).
3. Over the following 4-5 weeks intervention takes place for group 1, no intervention for group 2.
4. At week 5 assessment 2 takes place for all participants (this is post intervention for group 1 but still pre intervention for group 2.
5. Then group 2 does the intervention, group 1 has no intervention.
6. At week 10 -11 all participants have a 3rd assessment (this is post intervention for group 2 and follow up for group 1.
7. At week 15-16 half of group 2 participants have a fourth (Follow up) assessment (not all are asked to do this due to timing of the school term and finishing dates for this involved sites)
Control group
Active

Outcomes
Primary outcome [1] 257458 0
At each assessment the primary measure is depressive symptoms as measured by the Childrens Depression Rating Scale, Revised (CDRS-R)
Timepoint [1] 257458 0
Pre treatment (for all participants)
At 5 weeks (post intervention for group 1 and pre intervention for group 2)
At 10 weeks (this is a follow up point for group 1 and post intervention for group 2).
At 15 weeks (follow up point for 50% of those in group 2 only).
Secondary outcome [1] 262629 0
Quality of life as measured by the Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q).
Timepoint [1] 262629 0
Pre treatment (for all participants)
At 5 weeks (post intervention for group 1 and pre intervention for group 2)
At 10 weeks (this is a follow up point for group 1 and post intervention for group 2).
At 15 weeks (follow up point for 50% of those in group 2 only).
Secondary outcome [2] 262917 0
Locus of control as measured by the Childrens Nowicki Strickland Internal External Locus of control scale.
Timepoint [2] 262917 0
Pre treatment (for all participants)
At 5 weeks (post intervention for group 1 and pre intervention for group 2)
At 10 weeks (this is a follow up point for group 1 and post intervention for group 2).
At 15 weeks (follow up point for 50% of those in group 2 only).
Secondary outcome [3] 262919 0
Self reported depressive symptoms as measured by the Reynolds Adolescent Depression Scale (RADS-2)
Timepoint [3] 262919 0
Pre treatment (for all participants)
At 5 weeks (post intervention for group 1 and pre intervention for group 2)
At 10 weeks (this is a follow up point for group 1 and post intervention for group 2).
At 15 weeks (follow up point for 50% of those in group 2 only).
Secondary outcome [4] 262920 0
Anxiety symptoms as measured by the Spence Anxiety Scale.
Timepoint [4] 262920 0
Pre treatment (for all participants)
At 5 weeks (post intervention for group 1 and pre intervention for group 2)
At 10 weeks (this is a follow up point for group 1 and post intervention for group 2).
At 15 weeks (follow up point for 50% of those in group 2 only).
Secondary outcome [5] 262921 0
Hopelessness as measured by the Kazdin Hopelessness Scale (HPLS).
Timepoint [5] 262921 0
Pre treatment (for all participants)
At 5 weeks (post intervention for group 1 and pre intervention for group 2)
At 10 weeks (this is a follow up point for group 1 and post intervention for group 2).
At 15 weeks (follow up point for 50% of those in group 2 only).
Secondary outcome [6] 262922 0
Satisfaction with treatment - short questionnaire and interview for young people who have completed the intervention.
Timepoint [6] 262922 0
At 5 weeks (for group 1 )
At 10 weeks (for group 1 and group 2).
At 15 weeks (follow up point for 50% of those in group 2 only).

Eligibility
Key inclusion criteria
young people aged 12-18 years who are in an Alternative Education, youth transition or intensive youth programmes for young people who are disengaged or at risk of being disengaged from mainstream education.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Young people who are already recieving CBT, Interpersonal Therapy or Selective Serotonin Reuptake Inhibitors (SSRI's) for depression.

Young people who have severe depression, current sucide risk or other severe mental health issue which may mean that they are unsafe on this programme.

Young people who have a disablity or insufficent english language that would result in them being unable to use the computer programme.

Young people who are not expected to be enrolled in the participating site for a 10 week period.

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)
students are invited to participate in the study by their tutor. Those who consent take part in a baseline interview. Once this is completed the participant opens a sealed envelope allocating them to treatment now or treatment delayed. Students who have symptoms of mild to moderate depression on the CDRS are the target participants. We aim to recurit 30 participants in this group. Interested students who have no or minimal depressive symptoms are able to participate if they wish. Outcome data for this group will be analysed separately from that of students with depressive symptoms. Students who have severe depression or safety issues are reffered for additonal assistance.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Assessments at week 5 and week 10 are recorded for 20% of participants and coded by a research assistant who is blind to their allocation. The outcome scores obtained by this research assistant are compared to those obtained by the main reseracher (who is not blinded). The checking of scores will be carried out an independent statistican and analysed for any systematic difference in results between the reseachers by participants treatment allocation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2156 0
New Zealand
State/province [1] 2156 0

Funding & Sponsors
Funding source category [1] 256173 0
Government body
Name [1] 256173 0
Ministry of Health
Country [1] 256173 0
New Zealand
Funding source category [2] 256174 0
Government body
Name [2] 256174 0
Tertiary Education Commission
Country [2] 256174 0
New Zealand
Primary sponsor type
Individual
Name
Theresa Fleming
Address
Dept of Psychological Medicine
University of Auckland
PO Box 92019
Auckland Mail Centre
Auckland 1142.
New Zealand
Country
New Zealand
Secondary sponsor category [1] 251513 0
University
Name [1] 251513 0
University of Auckland
Address [1] 251513 0
Ths is supervised PhD work from the
Dr Sally Merry
Dept of Psychological Medicine
University of Auckland
PO Box 92019
Auckland Mail Centre
Auckland 1142.
New Zealand
Country [1] 251513 0
New Zealand
Other collaborator category [1] 1043 0
Individual
Name [1] 1043 0
Dr Sally Merry
Address [1] 1043 0
Dept of Psychological Medicine
University of Auckland
PO Box 92019
Auckland Mail Centre
Auckland 1142.
New Zealand
Country [1] 1043 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243909 0
Northern Y Regional Ethics committee
Ethics committee address [1] 243909 0
PO Box 1031 Hamilton,
Hamilton 3204
Ethics committee country [1] 243909 0
New Zealand
Date submitted for ethics approval [1] 243909 0
30/03/2009
Approval date [1] 243909 0
22/07/2009
Ethics approval number [1] 243909 0

Summary
Brief summary
This is a trial of a computerised cognitive behavioural therapy (c-cbt) programme for young people who outside of, or poorly engaged with, mainstream education. The programme is designed to reduce depressive symptoms. Participants are randomised to the c-cbt programme now, or beginning in 5 weeks time. The programme has 7 levels which take 20-30 minutes each. Participants usually do 2 levels per week. Participants are re-assessed at 5 and at 10 weeks time. Fifty percent of students who are in the delayed start group are reassessed at 15 weeks time. Measures include depressive symptoms (CRDS and RADS) anxiety symptoms (Spence), Quality of Life (PQLS), Hopelessness (HPLS) and locus of control. Satisfaction with treatment and beliefs about treatment and the intervention are explored using semi structured interviews before, after the intervention and at 4 weeks follow up. Parents and tutors are invited to give feedback too, via semi structured interviews. The target number of participants is 30 young people who have symptoms of mild to moderate depression.
Trial website
www.sparx.org.nz
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30321 0
Address 30321 0
Country 30321 0
Phone 30321 0
Fax 30321 0
Email 30321 0
Contact person for public queries
Name 13568 0
Theresa Fleming
Address 13568 0
Dept of Psychological Medicine
University of Auckland
PO Box 92019
Auckland Mail Centre
Auckland 1142.
Country 13568 0
New Zealand
Phone 13568 0
64 9 3737599 extn 87891
Fax 13568 0
64 9 3737013
Email 13568 0
[email protected]
Contact person for scientific queries
Name 4496 0
Theresa Fleming
Address 4496 0
Dept of Psychological Medicine
University of Auckland
PO Box 92019
Auckland Mail Centre
Auckland 1142.
Country 4496 0
New Zealand
Phone 4496 0
64 9 3737599 extn 87891
Fax 4496 0
Email 4496 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
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4269Study results articleYes Publication of trial results: FLEMING T, DIXON R,... [More Details]

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