Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001604291
Ethics application status
Approved
Date submitted
20/09/2018
Date registered
27/09/2018
Date last updated
13/12/2019
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial of the Uprise online program for university students
Scientific title
A randomised control trial of the Uprise online program targeting anxiety, depression, and stress in university students
Secondary ID [1] 296136 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 309724 0
Condition category
Condition code
Mental Health 308527 308527 0 0
Anxiety
Mental Health 308528 308528 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an online program called Uprise, which will be made accessible to participants as both an app and a website. Participants will complete a minimum of 4 modules of Uprise across 4 weeks: Mindset, Personal values, Mindfulness, and Stress management. One module will be made available to participants per week. Each module consists of a short introductory video about the relevant skills and a series of 1-6 additional videos or exercises to practice the skills. Module length ranges from 6 to 28 minutes.

Participants will be given access to the Uprise program by the trial coordinator. Completion of the modules is self-directed, with participants completing all of the Uprise modules online at a time and location that is convenient for them. Uprise also provides participants with in-website links to telephone or chat with a trained psychologist or counsellor at any point during the 4-week program.

Adherence to the intervention will be measured using meta-data from the Uprise website including time and date of activities, program progress, use of telephone and chat functions. Participants will also receive a weekly phone call from one of the researchers during the treatment phase to encourage use of Uprise and to help trouble-shoot any technical difficulties.
Intervention code [1] 312465 0
Behaviour
Comparator / control treatment
The control group will be waitlisted for four weeks after the baseline assessment. After four weeks they will then complete an additional assessment prior to commencing the uprise program.
Control group
Active

Outcomes
Primary outcome [1] 307506 0
mean Depression Anxiety Stress Scale (DASS21) - Stress subscale score
Timepoint [1] 307506 0
Baseline, 4 week follow up at end of treatment/end of waitlist [primary timepoint], 3 month follow up
Primary outcome [2] 307507 0
mean Centre for Epidemiological Studies - Depression score
Timepoint [2] 307507 0
Baseline, 4 week follow up at end of treatment/end of waitlist [primary timepoint], 3 month follow up
Primary outcome [3] 307508 0
mean Social Interaction Anxiety Scale score
Timepoint [3] 307508 0
Baseline, 4 week follow up at end of treatment/end of waitlist [primary timepoint], 3 month follow up
Secondary outcome [1] 352091 0
mean Depression Anxiety Stress Scale 21 score
Timepoint [1] 352091 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [2] 352092 0
mean Positive and Negative Affect Schedule - Trait and state version score
Timepoint [2] 352092 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [3] 352093 0
mean Kessler Psychological Distress Scale score
Timepoint [3] 352093 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [4] 352094 0
mean Lubben Social Network Scale score
Timepoint [4] 352094 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [5] 352095 0
mean Emotion Regulation Questionnaire score
Timepoint [5] 352095 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [6] 352096 0
mean Five Facet Mindfulness Questionnaire score
Timepoint [6] 352096 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [7] 352097 0
mean Cognitive Behavioural Processes Questionnaire score
Timepoint [7] 352097 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [8] 352098 0
mean Beck Cognitive Insight Scale score
Timepoint [8] 352098 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [9] 352099 0
mean Psychological Well-Being Scale score
Timepoint [9] 352099 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [10] 352100 0
mean Assessment of Quality of Life - 8 Dimensions score
Timepoint [10] 352100 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [11] 352101 0
mean Physical Health Questionnaire score
Timepoint [11] 352101 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [12] 352102 0
Short Form Health Survey 12 - Question 1 score
Timepoint [12] 352102 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [13] 352103 0
Uprise in-program metadata for completion of activities
Timepoint [13] 352103 0
Weekly when the participant logs in to the program or upon completion of the module
Secondary outcome [14] 352104 0
World Health Organisation - Five Well-Being Index score
Timepoint [14] 352104 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [15] 352105 0
Perceived Stress Scale - 4 score
Timepoint [15] 352105 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [16] 352106 0
Modified Sheehan Disability Scale score
Timepoint [16] 352106 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up
Secondary outcome [17] 352107 0
Uprise Acceptability Measure score. An 8-item self-report scale created by Uprise to measure participant satisfaction with different components of the program.
Timepoint [17] 352107 0
Immediately post-program
Secondary outcome [18] 352273 0
Uprise in-program metadata for program progress
Timepoint [18] 352273 0
Weekly when the participant logs in to the program and at end of treatment
Secondary outcome [19] 352274 0
Uprise in-program metadata for use of telephone and chat functions
Timepoint [19] 352274 0
Weekly when the participant logs in to the program and at the end of treatment
Secondary outcome [20] 377246 0
mean UCLA Loneliness Scale - Version 3 score
Timepoint [20] 377246 0
Baseline, 4 week follow up at end of treatment/end of waitlist, 3 month follow up

Eligibility
Key inclusion criteria
1. 17-26 years old
2. Currently enrolled as a student at an Australian university
3. English is their primary language or competent in English (reading and comprehension)
4. Able to attend Swinburne University of Technology Hawthorn campus, receive a phone call or video conference call for assessments
Minimum age
17 Years
Maximum age
26 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Presence of acute clinical psychiatric symptoms in the past month (e.g., depression, anxiety, psychosis)
2. Psychiatric hospitalisation in the past month
3. Reports any level of suicidality risk (mild-severe)
4. Reports moderate or severe levels of distress (score equal to or more than 25 on the Kessler Psychological Distress Scale) during screening assessment
5. Reports any level of risk of harm to others
6. Reports any level of risk of damage to objects or property

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization using computerized sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Assignment is to either immediate intervention or waitlist control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analyses were conducted for the three primary outcome variables (i.e. loneliness, depression and social anxiety) based on published population means and standard deviations, and reported effects of similar interventions. Assuming the best possible scenario (i.e. best effect size, smallest standard deviation), the analyses revealed a minimum 35 participants would be required in each group to detect changes in all three target outcome variables. The worst-case scenario would require 85 students per group to detect effects in just one of the outcome variables. Given funding constraints, we are also only able to recruit 35 participants in each arm.

Data analysis will include correlation, regression, analysis of variance, multi-level modelling, and structural equation modelling of participants’ data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2018
Actual
27/11/2018
Date of last participant enrolment
Anticipated
1/07/2019
Actual
12/06/2019
Date of last data collection
Anticipated
6/12/2019
Actual
23/11/2019
Sample size
Target
70
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300723 0
Commercial sector/Industry
Name [1] 300723 0
Medibank Private Limited
Country [1] 300723 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Swinburne University of Technology,
P O Box 218,
HAWTHORN VIC 3122
Country
Australia
Secondary sponsor category [1] 300263 0
Commercial sector/Industry
Name [1] 300263 0
Uprise
Address [1] 300263 0
Michael Crouch Innovation Centre,
University of New South Wales,
Kensington, NSW, 2033
Country [1] 300263 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301505 0
Swinburne University Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 301505 0
Ethics committee country [1] 301505 0
Australia
Date submitted for ethics approval [1] 301505 0
Approval date [1] 301505 0
12/09/2018
Ethics approval number [1] 301505 0
SHR Project 2018/205

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

Contacts
Principal investigator
Name 87226 0
Dr Michelle Lim
Address 87226 0
Social Health and Wellbeing (SHAW) Laboratory
Iverson Health Innovation Research Institute
Swinburne University of Technology
P.O Box 218
Hawthorn, VIC, 3122
Country 87226 0
Australia
Phone 87226 0
+61 3 9214 4868
Fax 87226 0
Email 87226 0
[email protected]
Contact person for public queries
Name 87227 0
Karra Harrington
Address 87227 0
Social Health and Wellbeing (SHAW) Laboratory
Iverson Health Innovation Research Institute
Swinburne University of Technology
P.O Box 218
Hawthorn, VIC, 3122
Country 87227 0
Australia
Phone 87227 0
+61 3 9214 4868
Fax 87227 0
Email 87227 0
[email protected]
Contact person for scientific queries
Name 87228 0
Michelle Lim
Address 87228 0
Social Health and Wellbeing (SHAW) Laboratory
Iverson Health Innovation Research Institute
Swinburne University of Technology
P.O Box 218
Hawthorn, VIC, 3122
Country 87228 0
Australia
Phone 87228 0
+61 3 9214 4868
Fax 87228 0
Email 87228 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will not be shared due to confidentiality. We do not have ethics approval to share data from this trial.


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.