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Development and Evaluation of A Digital Version of the REsilience Activities for every DaY (READY) Program for Adults with Multiple Sclerosis

Development and Evaluation of A Digital Version of the REsilience Activities for every DaY (READY) Program for Adults with Multiple Sclerosis

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000602820
Acronym
READY
Enrollment
56
Registered
2021-05-20
Start date
2022-05-19
Completion date
2022-08-31
Last updated
2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 th

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.

Sponsors

University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026