Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001320640
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
Identifying consumer characteristics, usage and the efficacy of Strengths eHealth wellbeing program.
Scientific title
Identifying consumer characteristics, usage and the efficacy of Strengths eHealth wellbeing program in adults from the general population.
Secondary ID [1] 285784 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Wellbeing 293671 0
Condition category
Condition code
Mental Health 293971 293971 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A simple baseline controlled open trial methodology will be used to investigate the efficacy of the Strengths eHealth program, as well as the characteristics of participants and their usage of the program. The Strengths eHealth program is housed within the Federation eHealth Platform. People visiting the website, in response to advertisements or through self interest, will be informed of the availability of the Strengths eHealth program and invited to participate in the study.

The Strengths eHealth program consists of three sessions designed to help a person identify, develop and maximize the use of their personal strengths to enhance their health and wellbeing. The program uses evidence based positive psychology principles and established face-to-face protocols that were operationalised and transformed for self-administration via a fully automated website with automated feedback (when online) and reminder mechanisms via automated email (e.g., when to complete certain questionnaires, when a new module becomes available, reminders to log on if they have not done so for several days while undertaking the program modules, reminders to complete the questionnaires if they have not been completed after several days of notification).

Participants will spend a week completing each session before moving onto the next session, so as to practise and to reinforce the session material learnt. Each session will last for approximately 15 minutes and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (approximately five minutes per day) to complete offline to practise the principles of identify and maximising strengths and asked to provide simple feedback on this practise at the next session.


Participants will be provided access to the Strengths eHealth program for the duration of the study (i.e., 15 weeks).
Intervention code [1] 290746 0
Behaviour
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293747 0
Mental Wellness using the Personal Wellbeing Index.
Timepoint [1] 293747 0
Pre-intervention, post intervention, 1 and 3 month follow-up.
Secondary outcome [1] 311733 0
Depression Anxiety and Stress symptoms using the DASS-21.
Timepoint [1] 311733 0
Pre-intervention, during intervention (Week 2, Week 3), post intervention and 1 and 3 month follow-up.
Secondary outcome [2] 311734 0
Perceived Stress using the Perceived Stress Scale.
Timepoint [2] 311734 0
Pre-intervention, post intervention and 1 and 3 month follow-up.
Secondary outcome [3] 311735 0
'Other' wellness measures using the Flourishing Scale and the Mental Health Continuum Short Form.
Timepoint [3] 311735 0
Pre-intervention, post intervention and 1 and 3 month follow-up.
Secondary outcome [4] 311736 0
Emotional Regulation using the Difficulties in Emotional Regulation Scale.
Timepoint [4] 311736 0
Pre-intervention, post intervention and 1 and 3 month follow-up.
Secondary outcome [5] 311737 0
Psychological Distress using the Kessler 6.
Timepoint [5] 311737 0
Pre-intervention, post intervention and 1 and 3 month follow-up.
Secondary outcome [6] 311738 0
Personality traits using the Ten Point Personality Inventory.
Timepoint [6] 311738 0
Pre-intervention.
Secondary outcome [7] 311739 0
Intervention Credibility using the Treatment Credibility Scale.
Timepoint [7] 311739 0
Pre-intervention.
Secondary outcome [8] 311740 0
Intervention Satisfaction using the Intervention Satisfaction Questionnaire.
Timepoint [8] 311740 0
Post Intervention.

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
No key exclusion criteria.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will enroll online and once pre-intervention assessments are completed, the Strengths eHealth program software will provide them with access to the Strengths eHealth program modules.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures ANOVA (within groups) to determine significant within groups changes over time.

Previous research has reported medium effects can be expected. Therefore, assuming a small to medium effect (i.e., f test = .35), significance set at 5% (p = .05), power at 80%, a sample of 27 will be required to demonstrate statistical significance. However allowing for a 30% attrition rate, we will be required to recruit a minimum of 39 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
39
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290348 0
University
Name [1] 290348 0
Federation University
Country [1] 290348 0
Australia
Primary sponsor type
University
Name
Federation Unversity
Address
University Drive, Mt Helen Campus, 3350, Victoria
Country
Australia
Secondary sponsor category [1] 289070 0
None
Name [1] 289070 0
Address [1] 289070 0
Country [1] 289070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292051 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 292051 0
Federation University Australia. Office 218, Building F, Mt Helen
Campus. PO Box 663 Ballarat VIC 3353
Ethics committee country [1] 292051 0
Australia
Date submitted for ethics approval [1] 292051 0
Approval date [1] 292051 0
25/06/2014
Ethics approval number [1] 292051 0
A14-084

Summary
Brief summary
A simple baseline controlled open trial methodology will be used to investigate the efficacy of the Strengths eHealth program, as well as the characteristics of participants and their usage of the program. The Strengths eHealth program is housed within the Federation eHealth Platform.

The Strengths eHealth program consists of three sessions designed to help a person identify, develop and maximize the use of their personal strengths to enhance their health and wellbeing. The program uses evidence based positive psychology principles and established face-to-face protocols that were operationalised and transformed for self-administration via a fully automated website with feedback and reminder mechanisms.

Participants will spend a week completing each session before moving onto the next session, so as to practise and to reinforce the session material learnt. Each session will last for approximately 15 minutes and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (approximately five minutes per day) to complete offline to practise the principles of identify and maximising strengths and asked to provide simple feedback on this practise at the next session.

Participants will complete online questionnaires at pre-program, during-program, post-program, and at a one and three month follow-up stage.
Trial website
www.personalstrengths.fedehealth.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53254 0
Prof Britt Klein
Address 53254 0
Federation University
University Drive, Mt Helen Campus, Victoria, 3350
Country 53254 0
Australia
Phone 53254 0
+61 3 53276717
Fax 53254 0
Email 53254 0
[email protected]
Contact person for public queries
Name 53255 0
Ms Sue Lauder
Address 53255 0
Federation University
University Drive, Mt Helen Campus, Victoria, 3350
Country 53255 0
Australia
Phone 53255 0
+61 3 53279845
Fax 53255 0
Email 53255 0
[email protected]
Contact person for scientific queries
Name 53256 0
Prof Britt Klein
Address 53256 0
Federation University
University Drive, Mt Helen Campus, Victoria, 3350
Country 53256 0
Australia
Phone 53256 0
+61 3 53276717
Fax 53256 0
Email 53256 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.