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Trial registered on ANZCTR


Registration number
ACTRN12611000700932
Ethics application status
Approved
Date submitted
6/07/2011
Date registered
7/07/2011
Date last updated
7/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a tailored online same-sex attracted youth focused transdiagnostic/multi-symptom mental health and wellbeing program
Scientific title
An online program for same sex attracted youth for the early intervention and prevention of multiple mental health symptoms
Secondary ID [1] 262554 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders 268217 0
Depression 268218 0
Condition category
Condition code
Mental Health 268345 268345 0 0
Anxiety
Mental Health 268346 268346 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An online mental health and wellbeing program for same-sex attracted youth aged between 18-25 years. The program includes 7 brief modules containing mental health and wellbeing information and exercises based on cognitive-behaviour therapy. The modules contain generic information and information and exercises specific for the symptoms participants endorse in an online assessment, which screens for generalised anxiety, obsessions and compulsions, posttraumatic stress, specific fear, social anxiety and depressive symptoms. It is recommended to participants that they spend an hour a week over 8 weeks reading through the online modules and practising offline exercises.
Intervention code [1] 266890 0
Early detection / Screening
Intervention code [2] 266901 0
Prevention
Comparator / control treatment
20-week delayed access control. Participants receive access to the intervention program after a 20-week delay. They are able to access any other mental health and wellbeing services in this time
Control group
Active

Outcomes
Primary outcome [1] 269122 0
Depressive symptoms, as measured by the Patient Health Questionnaire-9
Timepoint [1] 269122 0
For intervention group: pre-program (0 weeks), post-program (8 weeks), and 3 month follow-up (20 weeks)
For waitlist control group: pre-waitlist (0 weeks), 8 weeks post-waitlist (8 weeks), 20 weeks post-waitlist (20 weeks), and post-program (28 weeks)
Primary outcome [2] 269123 0
Symptoms of anxiety disorders:
- Generalised Anxiety Disorder (GAD-7)
- Panic Disorder (Panic Disorder Severity Scale)
- Obsessive Compulsive Disorder (Obsessive-Compulsive Inventory-Revised)
- Post-traumatic Stress Disorder (Posttraumatic Stress Disorder Checklist-Civilian Version)
- Specific Phobia (The Fear Questionnaire)
- Social Anxiety (Social Phobia Inventory)
Timepoint [2] 269123 0
For intervention group: pre-program (0 weeks), post-program (8 weeks), and 3 month follow-up (20 weeks)
For waitlist control group: pre-waitlist (0 weeks), 8 weeks post-waitlist (8 weeks), 20 weeks post-waitlist (20 weeks), and post-program (28 weeks)
Secondary outcome [1] 276974 0
Psychological distress, as measured by the Kessler-10
Timepoint [1] 276974 0
For intervention group: pre-program (0 weeks), on 3 occasions every two weeks during program access period, post-program (8 weeks), and 3 month follow-up (20 weeks)
For waitlist control group: pre-waitlist (0 weeks), 8 weeks post-waitlist (8 weeks), 20 weeks post-waitlist (20 weeks), on 3 occasions every two weeks during program access period, and post-program (28 weeks)
Secondary outcome [2] 276975 0
Satisfaction with life, as measured by Satisfaction with Life Scale
Timepoint [2] 276975 0
For intervention group: pre-program (0 weeks), post-program (8 weeks), and 3 month follow-up (20 weeks)
For waitlist control group: pre-waitlist (0 weeks), 8 weeks post-waitlist (8 weeks), 20 weeks post-waitlist (20 weeks), and post-program (28 weeks)
Secondary outcome [3] 276976 0
Emotional, psychological and social wellbeing, as measured by the Mental Health Continuum Short Form
Timepoint [3] 276976 0
For intervention group: pre-program (0 weeks), post-program (8 weeks), and 3 month follow-up (20 weeks)
For waitlist control group: pre-waitlist (0 weeks), 8 weeks post-waitlist (8 weeks), 20 weeks post-waitlist (20 weeks), and post-program (28 weeks)
Secondary outcome [4] 276977 0
Internalised homophobia (attitudes towards one's same-sex attraction), as measured by the Internalised Homophobia Scale-Revised
Timepoint [4] 276977 0
For intervention group: pre-program (0 weeks), post-program (8 weeks), and 3 month follow-up (20 weeks)
For waitlist control group: pre-waitlist (0 weeks), 8 weeks post-waitlist (8 weeks), 20 weeks post-waitlist (20 weeks), and post-program (28 weeks)
Secondary outcome [5] 276978 0
Help-seeking attitudes - as measured by the Attitudes Toward Seeking Professional Psychological Help scale
Timepoint [5] 276978 0
For intervention group: pre-program (0 weeks), post-program (8 weeks), and 3 month follow-up (20 weeks)
For waitlist control group: pre-waitlist (0 weeks), 8 weeks post-waitlist (8 weeks), 20 weeks post-waitlist (20 weeks), and post-program (28 weeks)
Secondary outcome [6] 276979 0
Locus of control - extent to which a person believes that their mental health status is under the control of themselves, chance or powerful others - as measured by the Multidimensional Health Locus of Control Scales - Form C
Timepoint [6] 276979 0
For intervention group: pre-program (0 weeks)
For waitlist control group: pre-waitlist (0 weeks)
Secondary outcome [7] 276980 0
Program satisfaction as measured by an online survey developed for this study, the Intervention Evaluation Questionnaire
Timepoint [7] 276980 0
For both intervention and waitlist control groups: post-program

Eligibility
Key inclusion criteria
1. Australian resident
2. Aged between 18 and 25 years
3. Same-sex attracted
4. Access to the internet
5. Symptoms of anxiety and/or depression
The program being tested in this study is designed for people who have some symptoms of mental health difficulties but not diagnosed mental health disorders. People whose symptoms suggest an extremely severe level of mental health disorder will be advised to see face-to-face treatment but not excluded from taking part.
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Not an Australian resident
2. Aged under 18 or over 25 years
3. Not same-sex attracted
4. No access to the internet
5. No symptoms of anxiety or depression
The program being tested in this study is designed for people who have some symptoms of mental health difficulties but not diagnosed mental health disorders. People whose symptoms suggest an extremely severe level of mental health disorder will be advised to see face-to-face treatment but not excluded from taking part.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will go to www.anxietyonline.org.au in response to advertising. They will first read an information statement and if they wish to take part they provide online consent. They will then be taken through a set of pre-program questionnaires. At this stage, participants who have reached the cut-off score of at least one symptom of anxiety or depression will move on to the random allocation stage. Randomisation will be computer generated and then allocation to one of the two groups occurs. Participants will be advised on their computer screen of which group they have been allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An automated computerised randomisation system will be built to generate the random sequences of group allocation. This will be based on a permuted blocked randomisation method to allow for stratification of gender, ensuring that equal gender numbers are allocated to each of the two conditions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants in the intervention group receive the intervention after completing the pre-program assessment, which they can do at any time while the trial is open for recruitment. Participants in the intervention group receive the intervention group 20-weeks after completing the pre-program assessment. Therefore, participants will complete the program at different times over the course of the study depending on when they register.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267367 0
Charities/Societies/Foundations
Name [1] 267367 0
beyondblue Victorian Centre of Excellence in Depression, Anxiety and Related Disorders
Country [1] 267367 0
Australia
Funding source category [2] 267368 0
University
Name [2] 267368 0
National eTherapy Centre, Swinburne University
Country [2] 267368 0
Australia
Primary sponsor type
University
Name
National eTherapy Centre and BPsyC eTherapy Unit
Address
Mail H29, PO Box 218, Hawthorn, VIC, 3122
Country
Australia
Secondary sponsor category [1] 266438 0
None
Name [1] 266438 0
Address [1] 266438 0
Country [1] 266438 0
Other collaborator category [1] 252088 0
University
Name [1] 252088 0
University of Ballarat
Address [1] 252088 0
School of Behavioural and Social Sciences and Humanities
PO Box 663
Ballarat VIC 3353
Country [1] 252088 0
Australia
Other collaborator category [2] 252089 0
Charities/Societies/Foundations
Name [2] 252089 0
ALSO Foundation
Address [2] 252089 0
City Village, Level 8
225 Bourke St
Melbourne VIC 3000
Country [2] 252089 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269352 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 269352 0
Swinburne Research
Swinburne University
Mail H68, PO Box 218
Hawthorn, VIC, 3122
Ethics committee country [1] 269352 0
Australia
Date submitted for ethics approval [1] 269352 0
Approval date [1] 269352 0
20/06/2011
Ethics approval number [1] 269352 0
2011/109

Summary
Brief summary
This study aims to develop and evaluate an online mental health and wellbeing program for same-sex attracted youth (SSAY) aged between 18-25 years. The program will deliver symptom-relevant material across multiple mental health symptom categories, where relevant, so as to present individual users with an integrated mental health and wellbeing program that respects their individuality, and acknowledges the reality and frequency of co-occurring mental health problems. The mental health symptoms covered will include depressive symptoms, generalised anxiety, panic, obsessions, compulsions, post traumatic stress, specific phobia and social anxiety. In addition, participants will receive access to a module that provides psycho-educational information about suicide. By using the results of an automated online screening questionnaire, the program will tailor content based on participants' current symptom presentation and their gender. We will evaluate the outcomes and user acceptability and satisfaction of the mental health and wellbeing program with approximately 76 SSAY (recruiting about 200 initially to allow for attrition). A randomised controlled trial will be conducted, with assessments at pre-program, post-program and 3 month follow-up. Participants will be randomly allocated to receive the mental health and wellbeing program with treatment as usual or a 20 week delayed access control with treatment as usual.
Trial website
www.anxietyonline.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32825 0
Address 32825 0
Country 32825 0
Phone 32825 0
Fax 32825 0
Email 32825 0
Contact person for public queries
Name 16072 0
A/Prof Britt Klein
Address 16072 0
BPsyC eTherapy Research Unit and National eTherapy Centre
Faculty of Life and Social Sciences
Swinburne University of Technology
Mail H29, PO Box 218
Hawthorn, VIC, 3122
Country 16072 0
Australia
Phone 16072 0
+61 3 9214 8851
Fax 16072 0
Email 16072 0
[email protected]
Contact person for scientific queries
Name 7000 0
A/Prof Britt Klein
Address 7000 0
BPsyC eTherapy Research Unit and National eTherapy Centre
Faculty of Life and Social Sciences
Swinburne University of Technology
Mail H29, PO Box 218
Hawthorn, VIC, 3122
Country 7000 0
Australia
Phone 7000 0
+61 3 9214 8851
Fax 7000 0
Email 7000 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOut & Online effectiveness of a tailored online multi-symptom mental health and wellbeing program for same-sex attracted young adults: Study protocol for a randomised controlled trial.2014https://dx.doi.org/10.1186/1745-6215-15-504
N.B. These documents automatically identified may not have been verified by the study sponsor.