Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000473561
Ethics application status
Approved
Date submitted
30/04/2015
Date registered
14/05/2015
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating the effectiveness of a one module eHealth wellbeing program (THRIVE) on increasing wellbeing and decreasing stress.
Scientific title
A randomised controlled trial evaluating the effectiveness of a one module eHealth wellbeing program (THRIVE) on increasing mental wellbeing and optimism and decreasing depressive, anxiety and stress symptom levels in adults.
Secondary ID [1] 286612 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 294926 0
Anxiety 294927 0
Depression 294998 0
Condition category
Condition code
Mental Health 295178 295178 0 0
Anxiety
Mental Health 295263 295263 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A simple randomised controlled trial (RCT) design will be used to evaluate the effectiveness of a brief 3 week ehealth program designed to increase wellness and decrease stress (called THRIVE eHealth).

THRIVE eHealth is essentially a one module ‘tools’ based program, split into 6 key psychoeducational areas (i.e., relaxation, sleep, nutrition, exercise, goal setting and life balance) designed to help people enhance their mental and physical wellbeing. The entire module will take about 20 minutes to read, with an additional 60 minutes if all the wellbeing ‘tools’ are accessed (e.g., guided audio). Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked several questions during the study period to monitor their progress. The THRIVE module include text, graphics, audio, quizzes, and downloads. THRIVE can be accessible via web, mobile or tablet devices.

Participants randomised to the THRIVE eHealth (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Week 1-2) assessment, post-intervention assessment (Week 3) and a 1 month follow-up assessment (Week 7). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to THRIVE eHealth program following the 1 month follow-up assessment (Week 7). However the delayed access group will be asked to complete the post intervention assessment after they completed the THRIVE eHealth program (Week 9). Access to THRIVE will be provided for the entire trial period. Adherence will be measured by the overall percentage of the module completed by post assessments as well as questions regarding engagement levels.
Intervention code [1] 291743 0
Behaviour
Intervention code [2] 291813 0
Prevention
Comparator / control treatment
People allocated to the delayed access group will complete the same questionnaires as the immediate access condition, but will not have access to the THRIVE eHealth program for 7 weeks.
Control group
Active

Outcomes
Primary outcome [1] 294937 0
Mental health wellbeing will be measured using the MCH-SF
Timepoint [1] 294937 0
Pre intervention, post intervention and 1 month follow-up
Primary outcome [2] 294938 0
Negative affect (depression, anxiety and stress) will be measured using the DASS-21
Timepoint [2] 294938 0
Pre intervention, during intervention (Week 2), post intervention and 1 month follow-up
Primary outcome [3] 294939 0
Optimism will be measured using the LOT-R
Timepoint [3] 294939 0
Pre intervention, during intervention (Week 2), post intervention and 1 month follow-up
Secondary outcome [1] 314395 0
Personality traits will be measured using the TIPI
Timepoint [1] 314395 0
Pre-intervention
Secondary outcome [2] 314396 0
General psychological distress will be measured using the Kessler 6
Timepoint [2] 314396 0
Pre intervention, post intervention and 1 month follow-up
Secondary outcome [3] 314397 0
Affective styles will be measured using the ASQ
Timepoint [3] 314397 0
Pre intervention, post intervention and 1 month follow-up
Secondary outcome [4] 314398 0
Intervention satisfaction, including engagement, will be measured using the TSQ
Timepoint [4] 314398 0
Post intervention
Secondary outcome [5] 314399 0
Demographic and lifestyle/personal questions using a self developed measure (e.g., gender, age, sleep and exercise patterns)
Timepoint [5] 314399 0
Pre intervention, post intervention and at the 1 month follow-up

Eligibility
Key inclusion criteria
Participants must be 18 years or older, have access to the internet, provide consent and be able to register online using an email address.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be invited to register for the study on the THRIVE eHealth website where they will be taken to the Plain Language Information Statement and must provide informed consent to proceed. Following account creation, participants are asked to complete the pre-intervention online questionnaires. Once completed the participant is informed as to which condition they have been randomly allocated too (on screen and sent an automated email). The THRIVE eHealth program software randomly allocates (and informs) participants using a block design method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block design method.
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
1. Pre-, post- and follow-up variables will be subjected to repeated measures MANOVA and ANOVA to determine significant changes over time and between groups
2. Correlational and multiple regression analyses will be used to determine significant correlates of wellbeing and to determine any potential predictors and discriminators of attrition and adherence.
3. Open ended data obtained from intervention satisfaction may be analysed using protocols of content analysis to identify common themes.

Assuming a medium effect (i.e. GPower f test = 0.40), significance set at 5% (p = .05) and power at 80%, a total sample size of 107 (this figure also accounts for an expected attrition rate of 40%) will be required to demonstrate statistical significance on the primary outcome measure.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Release of a newer digital health platform.
Date of first participant enrolment
Anticipated
6/07/2015
Actual
4/09/2015
Date of last participant enrolment
Anticipated
13/03/2017
Actual
9/09/2016
Date of last data collection
Anticipated
Actual
31/10/2016
Sample size
Target
107
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291182 0
University
Name [1] 291182 0
Federation University
Country [1] 291182 0
Australia
Primary sponsor type
University
Name
Federation Unversity
Address
Centre for Biopsychosocial and eHealth Research & Innovation, University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 289862 0
None
Name [1] 289862 0
Address [1] 289862 0
Country [1] 289862 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292754 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 292754 0
Ethics committee country [1] 292754 0
Australia
Date submitted for ethics approval [1] 292754 0
Approval date [1] 292754 0
26/03/2015
Ethics approval number [1] 292754 0
A15-042

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

Contacts
Principal investigator
Name 56858 0
Prof Britt Klein
Address 56858 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 56858 0
Australia
Phone 56858 0
+61 3 53276717
Fax 56858 0
Email 56858 0
[email protected]
Contact person for public queries
Name 56859 0
Britt Klein
Address 56859 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 56859 0
Australia
Phone 56859 0
+61 3 53276717
Fax 56859 0
Email 56859 0
[email protected]
Contact person for scientific queries
Name 56860 0
Britt Klein
Address 56860 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 56860 0
Australia
Phone 56860 0
+61 3 53276717
Fax 56860 0
Email 56860 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.