Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000814279
Ethics application status
Approved
Date submitted
17/09/2009
Date registered
18/09/2009
Date last updated
24/06/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Youth e-therapy - Evaluation of a computerised self-help programme for same/both-sex attracted adolescents and young people questioning their sexuality with mild to moderate depression
Scientific title
Youth e-therapy - The effect of a computerised cognitive behavioural therapy (CCBT) programme on depressive symptoms in same/both-sex attracted adolescents and young people questioning their sexuality with mild to moderate depression
Secondary ID [1] 282725 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Same/both-sex attracted adolescents and young people questioning their sexuality aged 16 to 19 years old with mild to moderate depressive symptoms 243863 0
Condition category
Condition code
Mental Health 240037 240037 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be invited to complete a seven level CCBT programme (SPARX: The Rainbow Version) over 4-8 weeks under minimal supervision.

Participants can complete the programme at selected sites (e.g. the University of Auckland or Rainbow Youth) or at home.

The overall duration will be determined by the participant and the rate at which they complete all seven levels (although they will be encouraged to complete one to two levels per week).

The CCBT programme is steeped in a 3D fantasy game. The seven levels consist of interactive exercises and mini-games and include topics such as problem-solving, recognising negative cognitions, cognitive reframing, relaxation, dealing with negative emotions and interpersonal communication. Participants are encouraged to complete homework tasks after each level (called challenges) and are given a notebook which summarises the content of each level. Minor adaptations to the main CCBT programme have been made to ensure acceptability to a same/both-sex attracted or questioning sexuality youth population.
Intervention code [1] 241301 0
Treatment: Other
Comparator / control treatment
Same/both-sex attracted youth and young people questioning their sexuality will be compared to the opposite-sex attracted young people from the main Randomised Control Trial (RCT) [ACTRN12609000249257] with Dr Sally Merry as the Principal Investigator (PI).
Control group
Active

Outcomes
Primary outcome [1] 240936 0
The primary outcome measure is the change in depressive symptoms after completion of 4-8 weeks of CCBT compared with baseline as measured by the Child Depression Rating Scale (CDRS-R, which is a clinician based assessment).
Timepoint [1] 240936 0
Baseline; Month Two (post intervention), Month Five (i.e. at follow up, three months post intervention).
Secondary outcome [1] 257656 0
Depressive symptoms as rated by the participant using the Reynolds Adolescent Rating Scale (RADS).
Timepoint [1] 257656 0
Baseline; Month Two (post intervention), Month Five (i.e. at follow up, three months post intervention).
Secondary outcome [2] 257665 0
Mood and Feelings Questionniare (MFG) long form.
Timepoint [2] 257665 0
Baseline; Month Two (post intervention), Month Five (i.e. at follow up, three months post intervention).
Secondary outcome [3] 257666 0
Quality of life as measured by the Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) self rating scale.
Timepoint [3] 257666 0
Baseline; Month Two (post intervention), Month Five (i.e. at follow up, three months post intervention).
Secondary outcome [4] 257667 0
Clinical Global Impression as rated by the clinician.
Timepoint [4] 257667 0
Month Two (post intervention), Month Five (i.e. at follow up, three months post intervention).
Secondary outcome [5] 257668 0
Anxiety symptoms as measured by the Spence Anxiety self-rating scale.
Timepoint [5] 257668 0
Baseline; Month Two (post intervention), Month Five (i.e. at follow up, three months post intervention).
Secondary outcome [6] 257669 0
Hopelessness as measured by the Kazdin Hopelessness (HPLS) self-rating scale.
Timepoint [6] 257669 0
Baseline; Month Two (post intervention), Month Five (i.e. at follow up, three months post intervention).
Secondary outcome [7] 257670 0
Satisfaction with the intervention as rated by the participant.
Timepoint [7] 257670 0
Month one during the intervention; Month Two (post intervention), Month Five (i.e. at follow up, three months post intervention).

Eligibility
Key inclusion criteria
A young person will be eligible for the study if: They are same/both-sex attracted or are questioning their sexuality, they reside in the Greater Auckland region, have reasonable English language ability and are aged 16 to 19 years old.
Minimum age
13 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Young people that meet the inclusion criteria with no symptoms of depression can still be included and young people that meet the inclusion criteria and are severly depressed/suicidal can be included, but only if they are already receiving additional assistance.

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)
The study is an open trial extension to a RCT. All participants will receive the CCBT intervention and will be recruited via various gay/lesbian/bisexual networks and services.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A - However participants from this study will be compared to opposite-sex attracted participants from the main RCT (match sampling).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
19/05/2009
Actual
21/07/2009
Date of last participant enrolment
Anticipated
Actual
24/06/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2143 0
New Zealand
State/province [1] 2143 0

Funding & Sponsors
Funding source category [1] 243756 0
University
Name [1] 243756 0
Ministry of Health and University of Auckland (PhD Scholarship)
Country [1] 243756 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Werry Centre, Department of Psychological Medicine, FMHS, University of Auckland, Private Bag 92019, Auckland 1142.
Country
New Zealand
Secondary sponsor category [1] 237112 0
None
Name [1] 237112 0
Address [1] 237112 0
Country [1] 237112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243885 0
Multi-region Ethics Commitee
Ethics committee address [1] 243885 0
C/- Ministry of Health, PO Box 5013, Wellington 6011
Ethics committee country [1] 243885 0
New Zealand
Date submitted for ethics approval [1] 243885 0
Approval date [1] 243885 0
20/04/2009
Ethics approval number [1] 243885 0
MEC/09/01/002

Summary
Brief summary
Despite increased rates of depression amongst same/both-sex-attracted youth few of these depressed young people receive the treatment that they require. The difficulties same/both-sex-attracted young people face accessing help may be compounded by characteristics of this population, namely their small numbers, isolation and the double stigma of having a mental health issue and being same/both-sex-attracted. The challenge then is finding ways of overcoming these barriers in order to deliver effective therapy to this vulnerable group of young people. Computerised Cognitive Behavioural Therapy (CCBT) offers one means of rising to this challenge.
Trial website
Trial related presentations / publications
A manuscript based on the results of this study has been submitted to a peer-reviewed journal.
Public notes

Contacts
Principal investigator
Name 30299 0
Dr Mathijs Lucassen
Address 30299 0
Department of Psychological Medicine, FMHS
University of Auckland, 92019
AMC, Auckland 1142, New Zealand
Country 30299 0
New Zealand
Phone 30299 0
+64 9 923 2015
Fax 30299 0
Email 30299 0
[email protected]
Contact person for public queries
Name 13546 0
Dr Mathijs Lucassen
Address 13546 0
Werry Centre, Department of Psychological Medicine, FMHS, University of Auckland, Private Bag 92019, Auckland 1142.
Country 13546 0
New Zealand
Phone 13546 0
+64 9 373 7599 ext. 84938
Fax 13546 0
+64 9 373 7013
Email 13546 0
[email protected]
Contact person for scientific queries
Name 4474 0
Dr Mathijs Lucassen
Address 4474 0
Werry Centre, Department of Psychological Medicine, FMHS, University of Auckland, Private Bag 92019, Auckland 1142.
Country 4474 0
New Zealand
Phone 4474 0
+64 9 373 7599 ext. 84938
Fax 4474 0
+64 9 373 7013
Email 4474 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

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