Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000375853
Ethics application status
Approved
Date submitted
7/07/2020
Date registered
1/04/2021
Date last updated
11/10/2022
Date data sharing statement initially provided
1/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of a brief e-mental health program with Australian university students
Scientific title
Randomised controlled trial of the effect of a brief e-mental health program on symptoms of mental health problems in Australian university students.
Secondary ID [1] 301716 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 318168 0
anxiety 318169 0
psychological distress 318170 0
Condition category
Condition code
Mental Health 316185 316185 0 0
Depression
Mental Health 316186 316186 0 0
Anxiety
Mental Health 316503 316503 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a brief video-based e-mental health intervention that consists of 12 modules targeting the common mechanisms that underlie mental health problems in university students (e.g. low mood and negative thinking styles, worry/anxiety, procrastination, sleep problems). Each module consists of a brief video (transcript will be available through a link) followed by an exercise to practice the therapeutic technique that is described. An example of an exercise is a thought diary or a guided relaxation exercise. Two modules of the program will be e-mailed to participants during each week of the intervention period (6 weeks). The e-mail will also contain a link to a self-monitoring quiz (e.g. brief anxiety screener or procrastination screener) for participants to track their symptoms (2-5 mins). Self-monitoring quizzes include the PHQ-9, GAD-7, Westside exam anxiety scale, The Sleep Condition Indicator, The Almost Perfect Scale – Revised, The Procrastination Scale. The duration of each module is approximately 5 minutes. The modules are self-administered one-on-one via an e-mailed video, and can be accessed at a participants' location of choice. The videos contained in each module were developed specifically for this study. Adherence to the intervention will be monitored via video analytics and self-report questionnaire.
Intervention code [1] 318016 0
Treatment: Other
Comparator / control treatment
Participants allocated to the attention control condition will receive a weekly e-mail containing information on health topics not related to mental health. Example topics include: effects of sun exposure, how to keep your bones healthy. The modules are self-administered one-on-one via an e-mailed PDF, and can be accessed at a participants' location of choice. 12 modules of approximately 5 minutes duration will be administered.
Control group
Placebo

Outcomes
Primary outcome [1] 324364 0
Depression symptoms - PHQ-9
Timepoint [1] 324364 0
Baseline (pre-intervention commencement), post-intervention (at 6 weeks - primary timepoint), 3 months post intervention, and 6 months post intervention
Primary outcome [2] 324365 0
Anxiety symptoms - GAD-7
Timepoint [2] 324365 0
Baseline (pre-intervention commencement), post-intervention (at 6 weeks - primary timepoint), 3 months post intervention, and 6 months post intervention
Secondary outcome [1] 384451 0
Help seeking - General Help-seeking Questionnaire
Timepoint [1] 384451 0
Baseline, 6 weeks post baseline, 3 months post intervention, 6 months post intervention
Secondary outcome [2] 384452 0
Quality of life - EURO-HIS
Timepoint [2] 384452 0
Baseline, 6 weeks post baseline, 3 months post intervention, 6 months post intervention
Secondary outcome [3] 384453 0
Self-efficacy - Academic Self-Efficacy Scale
Timepoint [3] 384453 0
Baseline, 6 weeks post baseline, 3 months post intervention, 6 months post intervention
Secondary outcome [4] 386451 0
Social Anxiety Disorder Screener
Timepoint [4] 386451 0
Baseline, 6 weeks post baseline, 3 months post intervention, 6 months post intervention
Secondary outcome [5] 386452 0
General Self-Efficacy Scale (GSE-10)
Timepoint [5] 386452 0
Baseline, 12 weeks post baseline, 3 months post intervention, 6 months post intervention
Secondary outcome [6] 386453 0
Satisfaction (designed specifically for study)
Timepoint [6] 386453 0
Baseline, 6 weeks post baseline, 3 months post intervention, 6 months post intervention
Secondary outcome [7] 393553 0
Functioning (Re-QOL)
Timepoint [7] 393553 0
Baseline, 6 weeks post baseline, 3 months post intervention, 6 months post intervention
Secondary outcome [8] 393554 0
Psychological distress (DQ-5)
Timepoint [8] 393554 0
Baseline, 6 weeks post baseline, 3 months post intervention, 6 months post intervention
Secondary outcome [9] 393555 0
Wellbeing (WHO-5)
Timepoint [9] 393555 0
Baseline, 6 weeks post baseline, 3 months post intervention, 6 months post intervention
Secondary outcome [10] 403232 0
Body appreciation (BAS-2)
Timepoint [10] 403232 0
Baseline, 6 weeks post baseline, 3 months post intervention, 6 months post intervention
Secondary outcome [11] 403233 0
ENACT (skill acquisition and use) (designed specifically for study)
Timepoint [11] 403233 0
Baseline, 6 weeks post baseline, 3 months post intervention, 6 months post intervention

Eligibility
Key inclusion criteria
Aged 18 years or older
Current student of an Australian university
Currently residing in Australia
Elevated psychological distress (score of 8-17 on DQ-5)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No/mild psychological distress (score of less than 8 on DQ-5)
High/severe psychological distress (score of greater than 17 on DQ-5)
Diagnosis of bipolar disorder, schizophrenia, PTSD or a personality disorder and not currently receiving professional support

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 will be conducted by a researcher not involved with the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher who is independent of the trial will generate a sequence of random integers between the values of 1 and 2 at https://www.random.org/, and manually allocate participants to the trial conditions according to this sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/08/2021
Actual
31/08/2021
Date of last participant enrolment
Anticipated
31/07/2022
Actual
23/05/2022
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
666
Accrual to date
Final
523
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306153 0
Charities/Societies/Foundations
Name [1] 306153 0
Australian Rotary Health
Country [1] 306153 0
Australia
Primary sponsor type
Individual
Name
Louise Farrer
Address
63 Eggleston Rd
The Australian National University
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 306622 0
Individual
Name [1] 306622 0
Philip Batterham
Address [1] 306622 0
63 Eggleston Rd The Australian National University Canberra ACT 2601
Country [1] 306622 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306370 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 306370 0
Ethics committee country [1] 306370 0
Australia
Date submitted for ethics approval [1] 306370 0
14/07/2020
Approval date [1] 306370 0
28/08/2020
Ethics approval number [1] 306370 0

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

Contacts
Principal investigator
Name 103642 0
Dr Louise Farrer
Address 103642 0
63 Eggleston Rd The Australian National University Canberra ACT 2601
Country 103642 0
Australia
Phone 103642 0
+61 2 6125 8859
Fax 103642 0
Email 103642 0
[email protected]
Contact person for public queries
Name 103643 0
Louise Farrer
Address 103643 0
63 Eggleston Rd The Australian National University Canberra ACT 2601
Country 103643 0
Australia
Phone 103643 0
+61 2 6125 8859
Fax 103643 0
Email 103643 0
[email protected]
Contact person for scientific queries
Name 103644 0
Louise Farrer
Address 103644 0
63 Eggleston Rd The Australian National University Canberra ACT 2601
Country 103644 0
Australia
Phone 103644 0
+61 2 6125 8859
Fax 103644 0
Email 103644 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case by case basis at the discretion of the primary sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual participant data underlying published results

What types of analyses could be done with individual participant data?
• IPD meta-analyses and other purposes at the discretion of the primary sponsor

When can requests for individual participant data be made (start and end dates)?
From:
For 5 years following publication of research outputs

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approval by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.