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Trial registered on ANZCTR


Registration number
ACTRN12613000811707
Ethics application status
Approved
Date submitted
18/07/2013
Date registered
24/07/2013
Date last updated
27/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Computerised cognitive behavioural therapy (cCBT) with e-monitoring (oversight from clinicians provided electronically) for help seeking adolescents with depressive symptoms: clinical implementation trial to determine feasibility and acceptability.
Scientific title
Is computerised cognitive behavioural therapy (cCBT) program (called SPARX) paired with e-monitoring (clinician oversight provided electronically) feasible and acceptable to adolescents with depressive symptoms and their clinicians in an open implementation trial?
Secondary ID [1] 282854 0
NIL
Universal Trial Number (UTN)
U1111-1143-9375
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression
 289659 0
Anxiety 289660 0
Condition category
Condition code
Mental Health 289979 289979 0 0
Depression
Mental Health 289980 289980 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SPARX is a self-help computerized cognitive behavioural therapy (cCBT) program. It consists of seven modules. It includes elements of fantasy gaming (learning by doing) and direct teaching and reflection on skills learnt in the game. Participants are encouraged to use SPARX weekly (1 to 2 modules a week). Each module takes approximately 30 minutes to complete. Participants will complete SPARX on a computer with an internet connection (at home if a participant has access to broadband connection or in a clinic on a computer designated for SPARX, as agreed by a participant with his/her clinician). SPARX will be provided with e-monitoring. E-monitoring allows clinicians to oversee the progress of patients who are completing SPARX (mood, risk and adherence) remotely (i.e. via an electronic dashboard and system of email alerts).
Intervention code [1] 287543 0
Treatment: Other
Comparator / control treatment
Nil. This is an open implementation trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290029 0
The feasibility of SPARX online paired with the e-monitoring tool measured by uptake and completion rates.

Timepoint [1] 290029 0
Post treatment (week 6-8)
Primary outcome [2] 290030 0
The acceptability and satisfaction of SPARX paired with e-monitoring among young people and clinicians measured through a custom-made self-rated questionnaire.
Timepoint [2] 290030 0
Post treatment (week 6-8)
Secondary outcome [1] 303802 0
The clinical utility of the e-monitoring measured by feedback from participating clinicians using questionnaires and interviews/focus groups.
Timepoint [1] 303802 0
Post treatment (week 6-8)
Secondary outcome [2] 303803 0
The effectiveness of SPARX online paired with the e-monitoring tool (we will measure the extent of change in depressive symptoms and compare it with the results of the original randomised controlled trial conducted by Merry et al., 2012). Depressive symptoms will be measured the Reynold’s Adolescent Depression Rating Scale-2nd (RADS-2) and Mood and Feelings Questionnaire (MFQ; long version) at post-intervention.
Timepoint [2] 303803 0
Post treatment (week 6-8) and 6-week follow up (week 12-14)
Secondary outcome [3] 303804 0
The effectiveness of SPARX online paired with the e-monitoring tool (we will measure the extent of change in anxiety symptoms and compare it with the results of the original randomised controlled trial conducted by Merry et al., 2012). Anxiety symptoms will be measured by Spence Child Anxiety Scale (SCAS).
Timepoint [3] 303804 0
Post treatment (week 6-8) and 6-week follow up (week 12-14)
Secondary outcome [4] 303805 0
The cost and service efficiency associated with delivering SPARX with e-monitoring (though full cost-benefit analysis is beyond the scope of this project). Cost and efficiency will be assessed by measuring the frequency and time clinician spend on e-monitoring each week vs. estimated (projected) face-to-face therapy time that would be spent with a given patient.
Timepoint [4] 303805 0
Post-treatment (week 6-8)

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if:
1. Present with low mood or depressive symptoms or if a clinician determines low mood/depressive symptoms to be the primary problem.
2. They are aged 12 to 19 years of age (on day of the consent);
3. Newly referred/presenting to the health clinic or existing clients interested in this additional intervention;
4. The consent process will follow usual practice at health clinic (and any other site that may be added to this study). Individual consent will be collected from all participants. Parental consent will be collected if a clinician deems it appropriate.
5. They have sufficient English language ability to understand the program;
6. Can access a computer and Internet to use SPARX paired with e-monitoring. This may be a home computer but if the staff at the health clinic choose to offer SPARX online at the clinic, this will be available too.
Minimum age
12 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be ineligible in the study if:
1. They have severe depression, high suicide risk or other severe mental health issue which may mean that they are not safe to receive SPARX;
2. They have an intellectual disability or physical limitations that would result in them not being able to use the computer program
3. Currently is or has been receiving (past 3 months) CBT, interpersonal therapy or antidepressant medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will seek participants/patients presenting with a primary problem of low mood and symptoms of depression, deemed to warrant treatment at a health clinic. Clinicians will recruit participants. Written consent will be collected from all participants. Parental consent will be collected if deemed appropriate by a clinician following usual clinical protocol. All consenting participants will be asked to use SPARX at time and location of their choosing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is an open (uncontrolled) study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a clinical implementation study that follows on from two successful randomised controlled trials of SPARX. Inclusion and exclusion criteria are kept to a minimum to increase the generalisability of findings and reflect the clinical reality.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is a clinical implementation study, thus the primary objective are to evaluate feasibility, acceptability and clinical utility. The power calculations relate to the measures of effectiveness only.
A sample size of n=40 will enable detection of changes within the study group with effect sizes of 0.40 or more as statistically significant (a=0.05) with 80% power. Additionally, n=40 will enable detection of differences in changes between the proposed study and the published RCT results with effect sizes of 0.55 or more as statistically significant (a=0.05) with 80% power. In terms of the primary outcome the change in RADS-2 scores an effect size of 0.40 equates to a change of approximately 4 units and 0.55 equates to a difference in the change of approximately 6 units.
Initial analyses will quantify the changes over time within the study group, using means and percentages with paired t-tests and McNemar’s chi-square tests used to assess the statistical significance of the changes. We will also directly compare the changes from baseline to post intervention in our key outcomes measures in this study between those results achieved in the previous RCT, using ANCOVA for continuous outcomes and logistic regressions and chi-square tests for diagnostic (presence/absence) outcomes. A p-value <0.05 will be taken to indicate statistical significance. The comparisons of the changes will be summarised with 95% confidence intervals to establish the extent and potential importance of any differences in effects of SPARX between the original RCT and this study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/08/2013
Date of last participant enrolment
Anticipated
20/12/2013
Actual
20/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 5225 0
New Zealand
State/province [1] 5225 0

Funding & Sponsors
Funding source category [1] 287628 0
Government body
Name [1] 287628 0
Health Research Council - Research Partnership for New Zealand Health Delivery
Country [1] 287628 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 286372 0
Other
Name [1] 286372 0
Kapiti Youth Support (Youth Health and Support Centre)
Address [1] 286372 0
KYS One Stop Shop Trust, PO Box 300, Paraparaumu 5254
Country [1] 286372 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289599 0
Health and Disability Ethics Committee (Northern A)
Ethics committee address [1] 289599 0
Ethics committee country [1] 289599 0
New Zealand
Date submitted for ethics approval [1] 289599 0
Approval date [1] 289599 0
16/07/2013
Ethics approval number [1] 289599 0
13/NTA/92

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

Contacts
Principal investigator
Name 41522 0
A/Prof Sally Merry
Address 41522 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
Country 41522 0
New Zealand
Phone 41522 0
+64 9 923 6981
Fax 41522 0
+64 9 3737013
Email 41522 0
s.merry@auckland.ac.nz
Contact person for public queries
Name 41523 0
Karolina Stasiak
Address 41523 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
Country 41523 0
New Zealand
Phone 41523 0
64 9 9233890
Fax 41523 0
+64 9 3737013
Email 41523 0
k.stasiak@auckland.ac.nz
Contact person for scientific queries
Name 41524 0
Sally Merry
Address 41524 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
Country 41524 0
New Zealand
Phone 41524 0
+64 9 923 6981
Fax 41524 0
+64 9 3737013
Email 41524 0
s.merry@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
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Documents added automatically
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