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Trial registered on ANZCTR


Registration number
ACTRN12611000752965
Ethics application status
Approved
Date submitted
18/07/2011
Date registered
18/07/2011
Date last updated
18/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an internet-based well-being program (Mindfulness Online) for couples and individuals undergoing IVF treatment.
Scientific title
Evaluation of well-being and stress levels before and after completion of an internet-based well-being program (Mindfulness Online) for couples and individuals undergoing IVF treatment.
Secondary ID [1] 262642 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertility 268357 0
stress 268358 0
Condition category
Condition code
Reproductive Health and Childbirth 268485 268485 0 0
Fertility including in vitro fertilisation
Mental Health 268487 268487 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study proposes to offer a short, online, automated well-being program, called Mindfulness Online, to assist in reducing psychological distress and improving overall mental well-being for couples or individuals undertaking IVF.

Participants are offered access to the program before they commence a new treatment cycle (e.g,. before they start taking injections/drug treatments for that cycle).

They are asked to log in once a week for a total of about 15 minutes each time to complete exercises on mindfulness techniques. They are also asked to include 5-minutes a day of offline practice for the 3-week duration of the program.
Intervention code [1] 266994 0
Treatment: Other
Intervention code [2] 266996 0
Behaviour
Comparator / control treatment
The control group is a waitlist control group who will be given access to the program following completion of their IVF treatment cycle.
Control group
Active

Outcomes
Primary outcome [1] 269229 0
change in Mindfulness scores as measured by the Five Facet Mindfulness Questionnaire (FFMQ)
Timepoint [1] 269229 0
For the treatment group this is measured before completing the program, at completion of the program and one month after completion of the program. The waitlist control group completes the surveys at the same timepoints but without completing the program until the final survey is completed.
Primary outcome [2] 269230 0
change in measure of psychological distress as measured by the Depression, Anxiety, Stress Scale (DASS)
Timepoint [2] 269230 0
For the treatment group this is measured before completing the program, at completion of the program and one month after completion of the program. The waitlist control group completes the surveys at the same timepoints but without completing the program until the final survey is completed.
Primary outcome [3] 269231 0
Change in anxiety levels as measured by the State-Trait Anxiety Inventory (STAI)
Timepoint [3] 269231 0
For the treatment group this is measured before completing the program, at completion of the program and one month after completion of the program. The waitlist control group completes the surveys at the same timepoints but without completing the program until the final survey is completed.
Secondary outcome [1] 279169 0
difference in pre and post scores between participants using antagonist treatment cycle versus agonist treatment cycle
Timepoint [1] 279169 0
comparison of scores between the two groups before starting mindfulness online.

Eligibility
Key inclusion criteria
1) Any couple or individual seeking treatment from Monash IVF who is:
- able to read and understand written English at an 8th grade level
- between 25 and 35 years old
- preparing for either down regulation IVF cycle (with GnRH agonist) IVF cycle OR an antagonist IVF treatment cycle
- otherwise eligible to proceed with IVF treatment
Minimum age
25 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
If they are not eligible for IVF treatment (e.g., due to criminal record check or deemed unsuitable for current treatment), they will not be asked to participate in the study.

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)
Couples attending Monash IVF will be introduced to the project during their mandatory pre-treatment counseling session and given the consent form to read over. If they are willing to participate they will be randomized by computer (central randomisation) to either continue treatment as usual (control group) or the 3-week online mindfulness course (treatment group).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participant's email addresses are entered into the registration screen and they are randomly assigned to treatment or control by a central registration system. Except for the antagonist group who are automatically assigned to control group.
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267468 0
University
Name [1] 267468 0
Swinburne University
Country [1] 267468 0
Australia
Primary sponsor type
Individual
Name
Danielle Graber
Address
National eTherapy Centre
Swinburne University
Mail H29, P.O. Box 218
Hawthorn VIC 3122
Australia
Country
Australia
Secondary sponsor category [1] 266513 0
Commercial sector/Industry
Name [1] 266513 0
Monash IVF
Address [1] 266513 0
Level 1 Monash Surgical Private Hospital
252 Clayton Rd,
Clayton, VIC, 3168
Country [1] 266513 0
Australia
Other collaborator category [1] 252109 0
Hospital
Name [1] 252109 0
Monash Surgical Private Hospital
Address [1] 252109 0
Level 1 Monash Surgical Private Hospital
252 Clayton Rd,
Clayton, VIC, 3168
Country [1] 252109 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269437 0
Monash Surgical Private Hospital HREC
Ethics committee address [1] 269437 0
252-526 Clayton Rd
Clayton, Victoria. 3168
Ethics committee country [1] 269437 0
Australia
Date submitted for ethics approval [1] 269437 0
Approval date [1] 269437 0
24/02/2011
Ethics approval number [1] 269437 0
MSPH HREC Project 11090

Summary
Brief summary
The current study proposes to offer a short, online, automated well-being program, called Mindfulness Online, to assist in reducing psychological distress and improving overall mental well-being for couples or individuals undertaking IVF.

The program is designed to be used during the lead up to an IVF cycle.

A total of 50 couples undergoing standard IVF treatment will be randomised to either receive treatment as usual (wait-list control group) or complete the 3-week mindfulness program (treatment group).

Couples (or individual women) will be offered the information form during consultation with their IVF specialist or after their mandatory pre-treatment counselling session. If they consent they will complete an online survey before and after the 3 week program containing demographic questionnaires plus measures of well-being, depression, anxiety, stress and mindfulness.

IVF treatment outcomes will be recorded (e.g., pregnancy test results) and those in the treatment group will complete a compliance measure at the end of the program.

The same surveys will also be administered to 25 couples undertaking the newer antagonist IVF cycle pre- and post-cycle to compare with the waitlist control group to see if there is any difference in stress/well-being measures between the two protocols.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32888 0
Address 32888 0
Country 32888 0
Phone 32888 0
Fax 32888 0
Email 32888 0
Contact person for public queries
Name 16135 0
Danielle Graber
Address 16135 0
National eTherapy Centre
Faculty of Life and Social Sciences
Swinburne University
Mail H29, P.O. Box 218
Hawthorn VIC 3122
Australia
Country 16135 0
Australia
Phone 16135 0
+61 0408 466 235
Fax 16135 0
+61 3 9214 5260
Email 16135 0
[email protected]
Contact person for scientific queries
Name 7063 0
Danielle Graber
Address 7063 0
National eTherapy Centre
Faculty of Life and Social Sciences
Swinburne University
Mail H29, P.O. Box 218
Hawthorn VIC 3122
Australia
Country 7063 0
Australia
Phone 7063 0
+61 0408 466 235
Fax 7063 0
+61 3 9214 5260
Email 7063 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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