Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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 individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results
When will data be available (start and end dates)?
For 5 years following publication of research outputs
Available to whom?
Case by case basis at the discretion of the primary sponsor
Available for what types of analyses?
IPD meta-analyses and other purposes at the discretion of the primary sponsor
How or where can data be obtained?
Access subject to approval by Principal Investigator ([email protected])


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.