Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000915358
Ethics application status
Approved
Date submitted
2/05/2017
Date registered
22/06/2017
Date last updated
5/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An online intervention to prevent and treat mental health problems in university students
Scientific title
Pilot trial of an online intervention to prevent and treat depression in young people at university
Secondary ID [1] 291835 0
None
Universal Trial Number (UTN)
U1111-1196-1991
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 303080 0
anxiety 303130 0
Condition category
Condition code
Mental Health 302538 302538 0 0
Depression
Mental Health 302580 302580 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People who are interested in participating in the trial will be directed to a website containing project information. Eligible participants will continue to complete the baseline questionnaire. Following completion of the baseline questionnaire, participants will be randomised to receive either the intervention or control condition.

The Uni Virtual Clinic (UVC) is a transdiagnostic online service that targets four major groups of mental disorders (mood, anxiety, eating, substance use) and related issues that commonly affect university students. It provides 1) information factsheets that describe a range of disorders, and problems that university students may face. These are accessible through the main webpage, and can also be provided in a tailored form for the individual when they use the "problem-solving" tool for particular disorders or problems, as well as the screening and feedback tools. The problem-solving tool guides users through a particular problem to find the most appropriate help available on the UVC. The identification and provision of treatment through the clinic is personalised to each user through the use of this tool. The website also contains quizzes that provide feedback for common mental health problems and issues affecting students (e.g., perfectionism, exam anxiety), and brief tools that may help with these problems (e.g., mindfulness videos, how to cope with exam anxiety audio files, pleasant events scheduling written tool for depression).

Participants in the intervention condition will be instructed to use the UVC online for a period of 6 week; however, they will be free to use the website as much or as little as they choose to during this period. Given the tailored and flexible nature of the intervention, participants will be encouraged to use at least weekly, particular intervention tools (e.g. the problem solver, ongoing symptom monitoring, treatment packages) to direct their use of the intervention. Participants will be asked questions in the post-intervention survey to assess their adherence to the program.
Intervention code [1] 297947 0
Early detection / Screening
Intervention code [2] 297948 0
Treatment: Other
Intervention code [3] 297949 0
Prevention
Comparator / control treatment
Participants in the control condition will complete pre and post intervention measures, and will be provided with access to the UVC intervention following completion of assessments at 3-month follow-up.
Control group
Active

Outcomes
Primary outcome [1] 301958 0
Depression symptoms on the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 301958 0
Preintervention, post-intervention (6 weeks), follow-up (3-months)
Secondary outcome [1] 334366 0
Generalised anxiety symptoms on the Generalised Anxiety Disorder-7 (GAD-7)
Timepoint [1] 334366 0
Pre-intervention, post-intervention (6 weeks), follow-up (3 months).
Secondary outcome [2] 334367 0
Panic symptoms on the Patient Health Questionnaire-Panic
Timepoint [2] 334367 0
Pre-intervention, post-intervention (6 weeks), follow-up (3 months).
Secondary outcome [3] 334368 0
Social anxiety symptoms on the Social Phobia Screener
Timepoint [3] 334368 0
Pre-intervention, post-intervention (6 weeks), follow-up (3 months).
Secondary outcome [4] 334369 0
Quality of life - EURO-HIS quality of life instrument
Timepoint [4] 334369 0
Pre-intervention, post-intervention (6 weeks), follow-up (3 months).
Secondary outcome [5] 334370 0
Help seeking intentions and behaviours on the General Help seeking Questionnaire
Timepoint [5] 334370 0
Pre-intervention, post-intervention (6 weeks), follow-up (3 months).
Secondary outcome [6] 334371 0
Alcohol use using the 5-item version of the Alcohol Use Disorders Identification Test
Timepoint [6] 334371 0
Pre-intervention, post-intervention (6 weeks), follow-up (3 months).
Secondary outcome [7] 334476 0
Disability/days out of role (2 questions - days out of role, days cut-back on role)
Timepoint [7] 334476 0
Pre-intervention, post-intervention (6 weeks), follow-up (3 months).
Secondary outcome [8] 334477 0
Adherence - researcher-developed questions (n = 6)
Timepoint [8] 334477 0
Post-intervention
Secondary outcome [9] 334478 0
Satisfaction - researcher-developer questions (n = 6)
Timepoint [9] 334478 0
Post-intervention

Eligibility
Key inclusion criteria
(a) elevated psychological distress (Kessler Psychological Distress Scale (K10) score > 15), (b) current ANU student, and (c) aged over 18 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Randomisation carried out by researcher independent from the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number sequence generated using random.org.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
It is not possible to fully blind participants to their condition.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 100 participants (50 per condition) is needed to detect an effect of 0.6 between conditions with 80% power and = .05 (assuming an attrition rate of 10%). Data analyses will utilise an intention-to-treat approach (mixed effects repeated measures models), to establish the effectiveness of the intervention in reducing depressive symptoms (the primary outcome) over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/07/2017
Actual
27/07/2017
Date of last participant enrolment
Anticipated
17/08/2017
Actual
28/09/2017
Date of last data collection
Anticipated
31/12/2017
Actual
10/03/2018
Sample size
Target
100
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 296332 0
Charities/Societies/Foundations
Name [1] 296332 0
Society for Mental Health Research
Country [1] 296332 0
Australia
Primary sponsor type
Individual
Name
Dr Louise Farrer
Address
63 Eggleston Rd
The Australian National University
Acton, 2601
ACT
Country
Australia
Secondary sponsor category [1] 295260 0
Individual
Name [1] 295260 0
Dr Amelia Gulliver
Address [1] 295260 0
63 Eggleston Rd
The Australian National University
Acton, 2601
ACT
Country [1] 295260 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297562 0
The Australian National University Human Research Ethics Committee (HREC)
Ethics committee address [1] 297562 0
Ethics committee country [1] 297562 0
Australia
Date submitted for ethics approval [1] 297562 0
18/04/2017
Approval date [1] 297562 0
30/06/2017
Ethics approval number [1] 297562 0
Protocol: 2017/217

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

Contacts
Principal investigator
Name 74450 0
Dr Lou Farrer
Address 74450 0
63 Eggleston Rd
The Australian National University
Acton,
ACT, 2601
Country 74450 0
Australia
Phone 74450 0
+61261258859
Fax 74450 0
Email 74450 0
[email protected]
Contact person for public queries
Name 74451 0
Lou Farrer
Address 74451 0
63 Eggleston Rd
The Australian National University
Acton,
ACT, 2601
Country 74451 0
Australia
Phone 74451 0
+61261258859
Fax 74451 0
Email 74451 0
[email protected]
Contact person for scientific queries
Name 74452 0
Lou Farrer
Address 74452 0
63 Eggleston Rd
The Australian National University
Acton,
ACT, 2601
Country 74452 0
Australia
Phone 74452 0
+61261258859
Fax 74452 0
Email 74452 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
No additional documents have been identified.