Phase 3 Trial to Assess Benefits of Group Resilience Training Program
A Phase 3 trial will test the ability of a group resilience training program, called READY, to promote quality of life and better psychosocial outcomes in people with multiple sclerosis (MS).
Involving more than 200 MS patients, the trial will compare the benefits of READY training against those of a group relaxation program with regard to resilience and other parameters such as mood and quality of life.
Resilience — the capacity to recover or “bounce back” from challenges — plays an important role in lessening the adverse effects of psychological stress, according to researchers.
“It is expected that [this] study will contribute to the body of evidence on the efficacy and effectiveness of READY by comparing it with an active group intervention in frontline MS rehabilitation and clinical settings,” the team wrote.
The protocol for the trial was described in “A group resilience training program for people with multiple sclerosis: Study protocol of a multi-centre cluster-randomized controlled trial (multi-READY for MS),” published in the journal PLOS One.
In coping with disease symptoms and progression, changing daily life, and the uncertainty that comes with these changes, many MS patients experience anxiety, depression, and quality of life declines. Such psychological distress can, in turn, affect MS symptoms and disease relapses.
The READY program — REsilience and Activities for every DaY — was developed by an Australian team to promote resilience and restore more positive psychological outcomes.
It aims to enhance psychological flexibility based on the principles of acceptance and commitment (ACT) therapy. The program targets five established factors that help protect resilience: cognitive flexibility, acceptance, meaning, social connectedness, and values-based action.
Originally developed for the workplace, READY has since been adapted for multiple other uses, including as a resilience training program for people with medical conditions, including cancer, diabetes, and MS. A previous pilot evaluation — a case series study done in Australia — showed that the program led to beneficial outcomes on resilience, life quality, depression, and stress in people with MS.
Investigators in Italy then adapted READY to be used for MS patients in clinics in their country. A first Phase 2 pilot study (ISRCTN38971970) evaluated the program against a relaxation program in 37 people with MS.
While the program overall was well-accepted by MS patients, no significant differences in psychological outcomes were observed between individuals receiving READY training and those given relaxation therapy. But observed trends toward improved resilience, psychological flexibility, acceptance, and/or getting “distance” from one’s emotions supported further clinical testing.
Now, the randomized controlled trial (ISRCTN67194859) will evaluate READY among a much greater patient pool — 240 adults with MS from eight centers across Italy.
The participants will be randomly assigned to receive READY or the group relaxation program weekly for seven weeks, with a booster session five weeks later.
The study’s primary goal is to assess the change in resilience from the study’s start (baseline) to after the booster session, and at three- and six-month follow-ups. It will be measured with the Connor-Davidson Resilience Scale 25.
Secondary outcomes include any change in mood, health-related quality of life, well-being, and psychological flexibility.
The READY program will be administered among groups of 8–10 participants by psychologists who have undergone a training program. Sessions will consist of educational modules and exercises to put the program’s principles into practice. Patients also will receive a workbook and audio recordings of mindfulness exercises that will be used to help them practice at home.
Those in the control group will undergo a relaxation program under the supervision of a psychologist that also will include a workbook and audio recordings.
If face-to-face meetings are interrupted due to the COVID-19 pandemic, participants will still be able to complete the intervention through teleconferencing. It is thought that the principles which underlie READY may also mitigate the pandemic-associated mental health impact, according to researchers.
To evaluate this, information relating to each person’s experiences with COVID-19 and COVID-19-associated distress also will be collected at baseline and at a three-month follow-up.
“It is expected that READY will cultivate targeted resilience protective factors that will help [people with MS] effectively manage MS-related stressors,” the researchers wrote.
“Moreover, the READY program is relatively brief and highly structured, two characteristics that increase its affordability and ease of dissemination,” they added.