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Trial registered on ANZCTR


Registration number
ACTRN12614001308684
Ethics application status
Approved
Date submitted
4/12/2014
Date registered
16/12/2014
Date last updated
9/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial and consumer characteristics of the Stress eHealth wellbeing program.
Scientific title
The evaluation of the Stress eHealth wellbeing program in decreasing anxiety, depressive and stress symptoms in adults: A randomised controlled trial.
Secondary ID [1] 285782 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 293728 0
Condition category
Condition code
Mental Health 293966 293966 0 0
Anxiety
Mental Health 293967 293967 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 multi-component online program for decreasing stress and improving mental and physical wellbeing (called Stress eHealth).

The Stress eHealth program is placed within the Federation University eHealth Platform, which is a platform. People who visit the website, either directly or through seeing the program advertised, will be invited to take part in the Stress eHealth evaluation study. Those that consent will be randomly allocated to the Stress eHealth program (immediate access group) or a wait control group (delayed access group). The delayed access group will receive the intervention following a 10-week waiting period.

Stress eHealth contains five modules, delivered weekly over the five weeks, and is designed to help people cope with challenging situations and enhance their mental and physical wellbeing.

Each module will take between 10-20 minutes to complete. 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 at the beginning of each week, to monitor their progress.

Stress eHealth has five modules:
1. Stress and Health
2. Your Thoughts
3. Relaxation and Physical Activity
4. Social Connectedness and Strengths
5. Mindfulness


Participants randomised to the Stress eHealth (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Week 1-5) assessment, post-intervention assessment (Week 6) and a 1 and 3 month follow-up assessment (Week 10 & Week 18). The will have access the Stress eHealth program for the entire duration of the study.

Those randomly allocated to the waitlist condition will be asked to complete the same assessment phases, except for the 3 month follow-up assessment, as they will be given access to Stress eHealth program following the 1 month follow-up assessment (Week 10). However the delayed access group will be asked to complete the post intervention assessment after they complete the Stress eHealth program (Week 16).
Intervention code [1] 290743 0
Treatment: Other
Intervention code [2] 290795 0
Behaviour
Comparator / control treatment
Delayed access participants are asked to wait (will not receive access to Stress eHealth) but will be asked to complete the same assessment questionnaires as the intervention condition up to the 1 month follow-up assessment time point. Following completion of the 1 month follow-up assessments they will be provided access to Stress eHealth and then as to complete post-program questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 293742 0
Anxiety symptoms as measured by the GAD-7
Timepoint [1] 293742 0
Pre-intervention, during intervention (Week 2 and Week 4), post intervention and 1 and 3 month follow-up
Secondary outcome [1] 311717 0
Depressive symptoms as measured by the PHQ-9
Timepoint [1] 311717 0
Pre-intervention, during intervention (Week 2 and Week 4), post intervention and 1 and 3 month follow-up
Secondary outcome [2] 311718 0
Psychological Distress as measured by the Kessler 6.
Timepoint [2] 311718 0
Pre-intervention, post intervention and 1 and 3 month follow-up
Secondary outcome [3] 311719 0
Wellbeing as measured by the Mental Health Continuum-Short Form; Revised Life Orientation Test; and the Mindfulness Attention Awareness Scale.
Timepoint [3] 311719 0
Pre-intervention, post intervention and 1 and 3 month follow-up
Secondary outcome [4] 311720 0
Emotional Regulation as measured by Difficulties in Emotional Regulation Scale; the Affective Style Questionnaire and the; Acceptance and Action Questionnaire-II.
Timepoint [4] 311720 0
Pre-intervention, post intervention and 1 and 3 month follow-up
Secondary outcome [5] 311721 0
Perceived Stress as measured by the Perceived Stress Scale.
Timepoint [5] 311721 0
Pre-intervention, post intervention and 1 and 3 month follow-up
Secondary outcome [6] 311722 0
Personality Traits as measured by the Ten Item Personality Index.
Timepoint [6] 311722 0
Pre-intervention
Secondary outcome [7] 311723 0
Treatment Credibility as measured by the Treatment Credibility Scale.
Timepoint [7] 311723 0
Pre-intervention
Secondary outcome [8] 311724 0
Intervention Satisfaction as measured by the Intervention Satisfaction Questionnaire
Timepoint [8] 311724 0
Post intervention

Eligibility
Key inclusion criteria
Participants must be 18 years or older, have access to the internet, be able to register online using an email address and consent to the the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no key 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)
Participants will be invited to register for the study on the Stress 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 to. The Stress eHealth program software randomly allocates 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
Repeated measures ANOVA/mixed modelling.

Previous research has reported medium effects can be expected. Therefore, assuming a small-medium effect (i.e. GPower f(v) test = 0.40), significance set at 5% (p = .05), power at 80%, a sample of 64 will be required to demonstrate statistical significance. However allowing for a 40% attrition rate, we will be required to recruit 107 participants.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Given delays with getting the first digital platform ready to go 'live', a new program was written and uploaded during this 'delay wait time' and so this particular program was replaced with the more recent version. Therefore, there was no longer a need to run a trial on this 'older' version and so the study never commenced.
Date of first participant enrolment
Anticipated
22/12/2014
Actual
Date of last participant enrolment
Anticipated
30/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
107
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290346 0
University
Name [1] 290346 0
Federation University
Country [1] 290346 0
Australia
Primary sponsor type
University
Name
Federation Unversity
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 289068 0
None
Name [1] 289068 0
Address [1] 289068 0
Country [1] 289068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292049 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 292049 0
Federation University Australia. Office 218, Building F, Mt Helen Campus. PO Box 663 Ballarat VIC 3353
Ethics committee country [1] 292049 0
Australia
Date submitted for ethics approval [1] 292049 0
Approval date [1] 292049 0
31/07/2014
Ethics approval number [1] 292049 0
A14-096

Summary
Brief summary
This project will involve trialling a multi-component online stress reduction program (Stress eHealth) designed to reduce stress and anxiety and improve mental and physical wellbeing.

Those that consent will be randomly allocated to the Stress eHealth program (immediate access group) or a wait control group (delayed access group). The delayed access group will receive the intervention following a 10-week waiting period.

Participants randomised to the Stress eHealth (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Weeks 1-5) assessment, post-intervention assessment (Week 6) and a 1 and 3 month follow-up assessment (Week 10 & Week 18). Participants randomised to the delayed access group will complete the same assessment phases, except for the 3 month follow-up assessment, as they will be given access to Stress eHealth program following the 1 month follow-up assessment (Week 10). However the delayed access group will be asked to complete the post intervention assessment after they complete the Stress eHealth program (Week 16).
Trial website
www.stress.fedehealth.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52542 0
Prof Britt Klein
Address 52542 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 52542 0
Australia
Phone 52542 0
+61 3 53276717
Fax 52542 0
Email 52542 0
[email protected]
Contact person for public queries
Name 52543 0
Sue Lauder
Address 52543 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 52543 0
Australia
Phone 52543 0
+61 3 53279845
Fax 52543 0
Email 52543 0
[email protected]
Contact person for scientific queries
Name 52544 0
Britt Klein
Address 52544 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 52544 0
Australia
Phone 52544 0
+61 3 53276717
Fax 52544 0
Email 52544 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

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