Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000820505
Ethics application status
Approved
Date submitted
22/07/2015
Date registered
10/08/2015
Date last updated
16/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial and consumer characteristics of iMindTime eHealth: A comprehensive mindfulness and loving kindness meditation wellbeing online program.
Scientific title
A randomised controlled trial and consumer characteristics of iMindTime eHealth: Evaluating the effectiveness of a comprehensive mindfulness and loving kindness meditation wellbeing online program to increase mental wellbeing and optimism and decrease depressive, anxiety and stress symptom levels in adults.
Secondary ID [1] 287113 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 295638 0
Anxiety 295639 0
Depression 295640 0
Condition category
Condition code
Mental Health 295920 295920 0 0
Anxiety
Mental Health 295921 295921 0 0
Depression
Mental Health 296118 296118 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial will be used to investigate the effectiveness of the iMindTime eHealth program. People taking part in the study will be randomly allocated to either an immediate access to the program, or delayed access (7 week delay).

The iMindTime eHealth program consists of six brief sessions, over 3 weeks, designed to make an individual more mindful or increase awareness of moment-to-moment experiences (e.g., thoughts, feelings, sensations) and simply accepting what is there without wanting it to change in any way. Participants will spend three days on each session before moving onto the next session. Each session will take 5-10 minutes to read and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10-20 minutes per day) to complete offline to practise the principles of specific mindfulness exercises (i.e., mindfulness of the breath, mindfulness of body sensations, mindfulness of emotions, mindfulness of sounds, mindfulness of thoughts and loving kindness meditation) and asked to provide simple feedback on this practise at the next session. 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 iMindTime sessions include text, graphics, audio, quizzes, and downloads. iMindTime can be accessible via web, mobile or tablet devices.

Participants randomised to the iMindTime eHealth (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Week 2) assessment, post-intervention assessment (Week 4) and a 1 month follow-up assessment (Week 8). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to iMindTime eHealth program following the 1 month follow-up assessment (Week 8). However the delayed access group will be asked to complete the post intervention assessment after they have completed the iMindTime eHealth program (Week 11). Access to iMindTime will be provided for the entire trial period. Adherence will be measured by the number of sessions completed by post assessment as well as questions regarding engagement levels.
Intervention code [1] 292358 0
Behaviour
Intervention code [2] 292359 0
Prevention
Intervention code [3] 292492 0
Lifestyle
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 iMindTime eHealth program for 7 weeks.
Control group
Active

Outcomes
Primary outcome [1] 295596 0
Mental health wellbeing will be measured using the MCH-SF
Timepoint [1] 295596 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Primary outcome [2] 295597 0
Negative affect (depression, anxiety and stress) will be measured using the DASS-21
Timepoint [2] 295597 0
Pre intervention (Week 0), during intervention (Week 2), post intervention (Week 4) and 1 month follow-up (Week 8)
Primary outcome [3] 295598 0
Optimism will be measured using the LOT-R
Timepoint [3] 295598 0
Pre intervention (Week 0), during intervention (Week 2), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [1] 315939 0
Personality traits will be measured using the TIPI
Timepoint [1] 315939 0
Pre-intervention (Week 0)
Secondary outcome [2] 315940 0
General psychological distress will be measured using the Kessler 6
Timepoint [2] 315940 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [3] 315941 0
Affective styles will be measured using the ASQ
Timepoint [3] 315941 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [4] 315942 0
Intervention satisfaction, including engagement, will be measured using the TSQ
Timepoint [4] 315942 0
Post intervention (week 8)
Secondary outcome [5] 315943 0
Demographic and lifestyle/personal questions using a self developed measure (e.g., sleep and exercise patterns).
Timepoint [5] 315943 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)

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
Under 18 years of age, non-English speaking, no internet access

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 iMindTime 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 (sent an automated email). The iMindTime 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 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 and exit questionnaires may be analysed using protocols of content analysis to identify common themes.

Assuming a small-medium effect (i.e., GPower f test = 0.40), significance set at 5% (p = .05), 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.

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 and iMindTime program.
Date of first participant enrolment
Anticipated
27/08/2015
Actual
4/09/2015
Date of last participant enrolment
Anticipated
13/03/2017
Actual
13/05/2017
Date of last data collection
Anticipated
Actual
4/06/2017
Sample size
Target
107
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291671 0
University
Name [1] 291671 0
Federation University
Country [1] 291671 0
Australia
Primary sponsor type
University
Name
Federation University
Address
Centre for Biopsychosocial and eHealth Research & Innovation, University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 290345 0
None
Name [1] 290345 0
Address [1] 290345 0
Country [1] 290345 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293201 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 293201 0
Federation University Australia. Office 218, Building F, Mt Helen Campus. PO Box 663 Ballarat VIC 3353
Ethics committee country [1] 293201 0
Australia
Date submitted for ethics approval [1] 293201 0
Approval date [1] 293201 0
03/08/2015
Ethics approval number [1] 293201 0
A15-115

Summary
Brief summary
A randomised controlled trial will be used to investigate the effectiveness of the iMindTime eHealth program. The iMindTime program will be placed 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 iMindTime program and invited to participate in the study. People who consent to take part in the study will be randomly allocated to either an immediate access to the program, or delayed access (7 week delay).

The iMindTime eHealth program consists of six brief sessions, over 3 weeks, designed to make an individual more mindful or increase awareness of moment-to-moment experiences (e.g., thoughts, feelings, sensations) and simply accepting what is there without wanting it to change in any way. Participants will spend three days on each session before moving onto the next session. Each session will require 5-10 minutes to read and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10-20 minutes per day) to complete offline to practise the principles of specific mindfulness exercises (i.e., mindfulness of the breath, mindfulness of body sensations, mindfulness of emotions, mindfulness of sounds, mindfulness of thoughts and loving kindness meditation) and asked to provide simple feedback on this practise at the next session. 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.

Participants randomised to the iMindTime eHealth (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Week 2) assessment, post-intervention assessment (Week 4) and a 1 month follow-up assessment (Week 8). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to iMindTime eHealth program following the 1 month follow-up assessment (Week 8). However the delayed access group will be asked to complete the post intervention assessment after they have completed the iMindeHealth program (Week 11).

It is expected that people who undertake iMindTime will show increases in mental wellbeing and optimism and reductions in negative affect at post and follow-up time points
Trial website
https://imindtime.fedehealth.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58878 0
Prof Britt Klein
Address 58878 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 58878 0
Australia
Phone 58878 0
+61 353276717
Fax 58878 0
Email 58878 0
[email protected]
Contact person for public queries
Name 58879 0
Prof Britt Klein
Address 58879 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 58879 0
Australia
Phone 58879 0
+61 353276717
Fax 58879 0
Email 58879 0
[email protected]
Contact person for scientific queries
Name 58880 0
Prof Britt Klein
Address 58880 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 58880 0
Australia
Phone 58880 0
+61 353276717
Fax 58880 0
Email 58880 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.