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Trial registered on ANZCTR


Registration number
ACTRN12621000602820
Ethics application status
Approved
Date submitted
15/01/2021
Date registered
20/05/2021
Date last updated
20/05/2021
Date data sharing statement initially provided
20/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and Evaluation of A Digital Version of the REsilience Activities for every DaY (READY) Program for Adults with Multiple Sclerosis
Scientific title
Development and Evaluation of A Digital Version of the REsilience Activities for every DaY (READY) Program for Adults with Multiple Sclerosis
Secondary ID [1] 302916 0
Nil known
Universal Trial Number (UTN)
U1111-1262-1108
Trial acronym
READY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 319936 0
Condition category
Condition code
Neurological 317874 317874 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Digital READY for MS

This trial will involve an evaluation of the digital READY for MS program through a randomized controlled trial (RCT). Partizan will recruit people with MS from their client membership to participate in the study. Participants will be limited to MS patients enrolled in the MS Alliance and who take Biogen MS medications for patients with relapse-remitting MS. The reason for this is that they are being recruited through MS Alliance patient support program, which is part of the eligibility criteria of the program.

The study will have a digital READY for MS intervention condition and a waitlist control (WLC) group. Participants will be randomly assigned to one of the two conditions in the RCT such that all participants who seek to participate in the study will have the same chance of being allocated to the intervention condition. Those who are allocated to the wait list control condition will get access to the intervention after completing the post-intervention assessment.

Intervention

The digital READY for MS Program, which has been revised in accord with consumer feedback obtained in a prior phase of testing, will be hosted on Partizan’s MS Alliance online platform. The digital program will consist of 7 modules plus a booster session module. It is anticipated that each module will be of approximately 60 minutes duration. It will be recommended that modules be completed weekly, although weekly completion of modules will not be enforced. Modules will only be completed in sequential order. Previous module exercises will be able to be repeated, but participants will not progress forward until completing the previous module.

The digital READY for MS program will consist of the following 7 modules: Introduction to the READY Resilience Model, Mindfulness, Defusion, Self-as-context, Acceptance, Values and Meaningful Action, Review and Future Planning. The booster module will provide a review of program information. Each module will provide information, experiential exercises, instructions between module practice and reading material.

The hard copy READY Personal Plan will direct participants in home practice tasks which will be completed after each module. The completion of in-module exercises and between module home practice is essential as these provide the opportunities for participants to individually tailor program content to their personal needs and to develop resilience skills and attributes.

Five weeks after completing the seventh module participants will be invited to complete the booster module. During this 5-week period participants will be able to revisit prior modules. Completion of the booster module will denote completion of the program; however, participants will be provided ongoing access to the program for a further 6 months should they wish to revise material or repeat exercises.

There will be no face-to-face contact offered to participants during the study; however, automated reminder emails or SMS messages will be sent to prompt timely completion of modules. In addition, emails or SMS messages will be sent to participants reinforcing participant progress.

The digital intervention will provide information via text on the screen, audio recordings of orally delivered information, interactive exercises, instructed experiential exercises (e.g., mindfulness meditations), and short videos.

The READY Personal Plan will provide instructions for home tasks. Examples of home tasks include: mindfulness exercises, monitoring specified behaviours, recording practice of intervention techniques. It is estimated that the duration of home tasks per week will be approximately 70 minutes.

Reminder emails or SMS messages will be sent to participants weekly for the duration of the delivery of the 7 weekly modules and one following the booster module.

The commencement and completion date of modules will be tracked. Standard website navigation data in aggregate form would be obtained from Google Analytics.

The READY Personal Plan is identical to that used and described in other published evaluations of the READY program with some minor modifications for the digital version of READY. Its source name is READY Personal Plan.
Intervention code [1] 319199 0
Lifestyle
Intervention code [2] 319202 0
Behaviour
Comparator / control treatment
The control condition will be a wait list control (WLC). Those who are allocated to the WLC condition will get access to the intervention after completing the post-intervention assessment (7 weeks from the baseline assessment).
Control group
Active

Outcomes
Primary outcome [1] 325890 0
Change in resilience as measured by the 15-item Resilience Scale (RS-15; Neill & Dias, 2001).
Timepoint [1] 325890 0
The primary outcomes will be assessed at pre-intervention, post-intervention (7 weeks from pre-intervention, primary endpoint), and at 3-month follow-up (19 weeks from pre-intervention).
Secondary outcome [1] 389453 0
Psychological Flexibility. The 30-item psychological flexibility scale of the Multidimensional Psychological Flexibility Inventory will be used to assess psychological flexibility (Rolffs, Rogge, & Wilson, 2016). This scale assesses the six core ACT processes which are resilience protective factors.
Timepoint [1] 389453 0
The secondary outcome will be assessed at pre-intervention, post-intervention (7 weeks from pre-intervention), and at 3-month follow-up (19 weeks from pre-intervention).
Secondary outcome [2] 389480 0
Change in quality of life (QoL) as measured by the Multiple Sclerosis Quality of Life Instrument (Vickrey, Hays, Harooni, Myers, & Ellison, 1995).

QoL consists of 8 health QoL subscales (physical health, role limitations due to physical problems, pain, energy, health perceptions, social function, health distress, sexual function) and 4 mental health QoL subscales (emotional wellbeing, role limitations due to emotional problems, health distress, cognitive function).
Timepoint [2] 389480 0
The secondary outcome will be assessed at pre-intervention, post-intervention (7 weeks from pre-intervention), and at 3-month follow-up (19 weeks from pre-intervention).
Secondary outcome [3] 389481 0
Change in distress (depression, anxiety, and stress) as measured by the 21-item version of the Depression, Anxiety, and Stress Scales (Lovibond & Lovibond, 1995).
Timepoint [3] 389481 0
The secondary outcome will be assessed at pre-intervention, post-intervention (7 weeks from pre-intervention), and at 3-month follow-up (19 weeks from pre-intervention).
Secondary outcome [4] 392591 0
The 10-item System Usability Scale (Brooke, 1996) will be used to measure program usability at post-intervention (Bangor, Kortum, & Miller, 2008).
Timepoint [4] 392591 0
The secondary outcome will be assessed at post-intervention (7 weeks from pre-intervention).
Secondary outcome [5] 392592 0
Participant satisfaction: intervention participants will be asked open-ended questions to elicit feedback on program satisfaction and helpfulness, and suggested improvements to the program.
Timepoint [5] 392592 0
The secondary outcome will be assessed at post-intervention (7 weeks from pre-intervention) and at 3-month follow-up (19 weeks from pre-intervention).

Eligibility
Key inclusion criteria
Inclusion criteria for the RCT will be:
• 18 years and older
• fluent in English
• represent typical variations of MS severity and disability
• male or female
• receiving support via the Partizan Australia MS Alliance Program

Partizan will recruit participants from its estimated 2,000 MS clients for the project. Participants will be limited to MS patients enrolled in the MS Alliance and who take Biogen MS medications for relapse-remitting MS. If needed, Partizan Phone Consultants may invite MS patients to participate in the program during a scheduled phone support call. Participation is completely optional. Partizan will manage the recruitment process for the project. The inclusion criteria will be: 18 years and older, and fluent in English. A potential participant will have approximately 6 weeks to consider participation.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned using computer software to one of the two conditions until the target of 45 participants per condition is reached.
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
A power analysis was also conducted to ensure an adequate number of participants before the study commencement. Based on this analysis, we will be able to detect an effect size of 0.44 with 45 patients per group. This supports the project target to recruit 90 participants across both groups.

Standardised scales will be used to assess the primary outcome of resilience, the secondary outcomes of quality of life, distress, and psychological flexibility (which underpins the ACT framework), participant MS characteristics, and usability of the digital program. All of these scales, with the exception of the psychological flexibility and program usability measures, have been used in prior MS research.

The primary and secondary outcomes will be assessed at pre-intervention, post-intervention, and the 3-month follow-up for intervention participants and pre-intervention, post-wait, and post-intervention for the WLC.

Repeated measures ANOVAs will examine changes from pre- to post-intervention between groups on primary and secondary outcomes. Additional repeated measures ANOVAs will be conducted with the intervention group for the post- to follow-up and pre- to follow-up time points.

Concurrent mediation analyses will be conducted using SPSS bootstrapping macro PROCESS (Preacher & Hayes, 2004) for mediation analyses incorporating the study conditions (e.g., pre- to post-intervention for intervention vs WLC). Pre- to post-intervention scores for the psychological flexibility measure will be examined as a potential mediator of change on the primary and secondary pre- to post-intervention outcomes if significant. In addition, temporal mediation analyses may be undertaken using bootstrapping macro MEMORE (Montoya & Hayes, 2016) for mediation analyses of single group repeated measures designs (e.g., pre- to post-intervention scores for the psychological flexibility measure as mediator on significant post-intervention to follow-up primary and secondary outcomes).

Measures of participant MS and socio-demographic characteristics will be assessed at pre-intervention. Participant satisfaction with the digital READY for MS Program will be assessed at post-intervention and follow-up. Program usability will be assessed at post-intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307336 0
Commercial sector/Industry
Name [1] 307336 0
Biogen Australia & New Zealand
Address [1] 307336 0
Level 3, 123 Epping Rd. North Ryde NSW 2113
Country [1] 307336 0
Australia
Funding source category [2] 307343 0
Commercial sector/Industry
Name [2] 307343 0
Partizan Worldwide Pty Ltd
Address [2] 307343 0
54 Victoria Street, McMahons Point, NSW 2060
Country [2] 307343 0
Australia
Funding source category [3] 307344 0
University
Name [3] 307344 0
University of Queensland
Address [3] 307344 0
University of Queensland, St. Lucia Campus, Brisbane, QLD 4072
Country [3] 307344 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Psychology, The University of Queensland, St Lucia Campus, Brisbane, QLD 4072
Country
Australia
Secondary sponsor category [1] 307985 0
Commercial sector/Industry
Name [1] 307985 0
UniQuest
Address [1] 307985 0
Level 7, General Purpose South Building (Building #78)
Staff House Road, The University of Queensland, St Lucia Campus, Brisbane, QLD 4072
Country [1] 307985 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307425 0
University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 307425 0
Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072, Australia
Ethics committee country [1] 307425 0
Australia
Date submitted for ethics approval [1] 307425 0
23/01/2019
Approval date [1] 307425 0
21/03/2019
Ethics approval number [1] 307425 0
2018001953

Summary
Brief summary
The purpose of this project is to evaluate a digital version of an empirically supported group resilience-training program for adults living with multiple sclerosis (MS) called REsilience Activities every DaY (READY) for MS. The program was developed by researchers at University of Queensland (UQ) and is designed to teach resilience skills for managing life challenges. It is based on acceptance and commitment therapy (ACT), which is a recent variant of the well-established cognitive and behaviour therapy. The project involves a collaboration between UQ and two industry partners: a patient support organisation (Partizan Worldwide Pty Ltd) and a pharmaceutical company, Biogen Australia Pty Ltd. It is predicted that compared to people with MS on a waitlist, those who participate in the READY program will report significantly greater improvements in resilience, quality of life and distress.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107198 0
Prof Kenneth Pakenham
Address 107198 0
School of Psychology, The University of Queensland, St Lucia Campus, Brisbane, QLD 4072
Country 107198 0
Australia
Phone 107198 0
+61 7 3365 6677
Fax 107198 0
Email 107198 0
kenp@psy.uq.edu.au
Contact person for public queries
Name 107199 0
Prof Kenneth Pakenham
Address 107199 0
School of Psychology, The University of Queensland, St Lucia Campus, Brisbane, QLD 4072
Country 107199 0
Australia
Phone 107199 0
+61 7 3365 6677
Fax 107199 0
Email 107199 0
kenp@psy.uq.edu.au
Contact person for scientific queries
Name 107200 0
Prof Kenneth Pakenham
Address 107200 0
School of Psychology, The University of Queensland, St Lucia Campus, Brisbane, QLD 4072
Country 107200 0
Australia
Phone 107200 0
+61 7 3365 6677
Fax 107200 0
Email 107200 0
kenp@psy.uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Multiple industry parties with commercial interests
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 9942 0
Informed consent form
Citation [1] 9942 0
Link [1] 9942 0
Email [1] 9942 0
kenp@psy.uq.edu.au
Other [1] 9942 0
Attachment [1] 9942 0
Summary results
No Results