A resilience group training program for people with multiple sclerosis: multi-centre trial (Multi_READY for MS)
| ISRCTN | ISRCTN67194859 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67194859 |
- Submission date
- 08/05/2020
- Registration date
- 14/05/2020
- Last edited
- 03/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Multiple sclerosis (MS) is a condition that can affect the brain and spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance.
It's a lifelong condition that can sometimes cause serious disability, although it can occasionally be mild. In many cases, it's possible to treat symptoms. Average life expectancy is slightly reduced for people with MS. It's most commonly diagnosed in people in their 20s and 30s, although it can develop at any age. It's about 2 to 3 times more common in women than men. MS is one of the most common causes of disability in younger adults.
Adjusting to MS can be highly demanding, and the disease can be a consistent source of stress. Resilience is an internal resource for alleviating the adverse effects of stress and sustaining good mental health through adversity.
In recent years, an Australian team developed and tested an Acceptance and Commitment Therapy (ACT)-based group resilience-training program: the REsilience and Activities for every DaY (READY). In view of the promising preliminary data on the READY for MS resilience training intervention, we decided to apply the READY for MS in Italy and to evaluate the efficacy of the program by following the Medical Research Council (MRC) framework for developing and evaluating complex interventions.
Aim: This study aims to evaluate the efficacy of the Italian READY for MS program in a multi-center cluster randomized trial.
Who can participate?
Adults over 18 years, diagnosed with MS.
What does the study involve?
Participants will be randomly allocated to receive the READY intervention consisting of seven weekly 2.5 hour sessions plus a 2.5 hour ‘booster’ session approximately five weeks after the seventh session, or a control program with the same number of sessions and schedules (but with different content).
What are the possible benefits and risks of participating?
This study will produce evidence on the efficacy of a brief, structured group intervention to promote resilience in people with MS by comparing it with an active group intervention. It is expected that, by empowering participant inner resources, Italian READY for MS can promote a personal growth that may help participants to prevent or overcome difficulties in adjustment to MS, and to live a full and rich life. The Italian READY for MS program is brief and highly structured, which ease its affordability.
We do not expect any negative effects due to the participation in this study.
Where is the study run from?
Fondazione IRCCS Istituto Neurologico Carlo Besta (Italy)
When is the study starting and how long is it expected to run for?
January 2020 to December 2022 (updated 09/04/2021, previously: December 2021; updated 20/10/2020, previously: September 2021)
Who is funding the study?
Fondazione Italiana Sclerosi Multipla – FISM (Italy)
Who is the main contact?
Ambra Mara Giovannetti, ambra.giovannetti@istituto-besta.it
Contact information
Scientific
Fondazione IRCCS Istituto Neurologico Carlo Besta
Via Celoria 11
Milano
20133
Italy
 ORCID ID |
0000-0002-7496-6727 |
|---|---|
| Phone | +39 (0)223942488 |
| ambra.giovannetti@istituto-besta.it |
Study information
| Study design | Multi-centre cluster randomised trial with an active control |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A resilience group training program for people with multiple sclerosis: multi-centre randomized controlled trial |
| Study acronym | Multi_READY for MS |
| Study objectives | Participants in the Italian READY for MS would show higher improvements on the primary outcome of resilience (CD-RISC 25) and on the secondary outcomes of mood (The Hospital Anxiety and Depression Scale, HADS; The Positive and Negative Affect Schedule, PANAS), health related quality of life (54-items MS Quality of Life inventory, MSQOL-54; the European Quality of life Five Dimensions, EQ-5D-3L), well-being (The short form of the Mental Health Continuum, MHC-SF) and psychological flexibility (The Comprehensive assessment Acceptance and Commitment Therapy processes, CompACT), compared to the control group (relaxation). |
| Ethics approval(s) | Current ethics approval as of 09/04/2021: Approved 15/04/2020, amendment approved 18/11/2020, Ethics committees of the Fondazione IRCCS Istituto Neurologico Carlo Besta (Via Celoria 11, Milano, 20133, Italy; +39 (0)2 2394.2321; comitatoetico@istituto-besta.it), ref: 71, amendment ref: 78 Previous ethics approval: Approved 15/04/2020, Ethics committees of the Fondazione IRCCS Istituto Neurologico Carlo Besta (Via Celoria 11, Milano, 20133, Italy; +39 (0)2 2394.2321; comitatoetico@istituto-besta.it), ref: 71 |
| Health condition(s) or problem(s) studied | Multiple sclerosis |
| Intervention | READY for MS is an adult ACT (Acceptance and Commitment Therapy) informed group resilience training program which consists of seven weekly 2.5 hour sessions plus a 2.5 hour ‘booster’ session approximately five weeks after the seventh session. Content of the seven weekly sessions is as follows: an introductory module (Introduction to the READY Resilience Model), five modules focusing on each of the six ACT processes (Mindfulness, Acceptance, Cognitive Defusion, Self-as-Context, Values, Meaningful Action), and a review module (Review and Future Planning). The booster session provides a review of the program content. The control program will match the study intervention in the number of sessions and schedules (but not in session content and length). Patient-reported outcome measures (PROMs) will be assessed immediately before, after the booster session, at three and six-month follow-up. Additional process data will capture participants’ attendance, homework completion, and facilitator perspectives on a weekly basis. Each session will be audio-recorded and self-rated by the facilitators. Two sessions for each Italian READY for MS group will be randomly selected and independently rated by two ACT experts to assess intervention fidelity. The control group session fidelity will be assessed following the same procedures except for the use of ACT-FM and audio recording assessment that will be done by one rate. Randomization will be provided by an independent randomization unit, using computer-based cluster randomization with minimization (2 factors: Centre and CDRISC score < 50 and ≥ 50). Groups will be allocated to Italian READY for MS or control intervention in a 1:1 ratio. Confirmation e-mails will be sent to the study coordinator and centre PI. The interventions will start within two weeks of the baseline assessment. |
| Intervention type | Behavioural |
| Primary outcome measure | Psychological resilience measured using the Connor-Davidson Resilience Scale 25 (CD-RISC 25) assessed immediately before (baseline visit, T0), after the booster session (T1, 12 weeks after baseline visit), at three (T2, 24 weeks after baseline visit), and six month follow-up (T2, 36 weeks after baseline visit) |
| Secondary outcome measures | Current secondary outcome measures as of 09/04/2021: Assessed immediately before (baseline visit, T0), after the booster session (T1, 12 weeks after baseline visit), at three (T2, 24 weeks after baseline visit), and six month follow-up (T2, 36 weeks after baseline visit): 1. Mood (The Hospital Anxiety and Depression Scale, HADS; The Positive and Negative Affect Schedule, PANAS) 2. Health related quality of life (54-items MS Quality of Life inventory, MSQOL-54; the European Quality of life Five Dimensions, EQ-5D-3L) 3. Well-being (The short form of the Mental Health Continuum, MHC-SF) 4. Psychological flexibility (the psychological flexibility subscale of The Multidimensional Psychological Flexibility Inventory, MPFI) Previous secondary outcome measures: Assessed immediately before (baseline visit, T0), after the booster session (T1, 12 weeks after baseline visit), at three (T2, 24 weeks after baseline visit), and six month follow-up (T2, 36 weeks after baseline visit): 1. Mood (The Hospital Anxiety and Depression Scale, HADS; The Positive and Negative Affect Schedule, PANAS) 2. Health related quality of life (54-items MS Quality of Life inventory, MSQOL-54; the European Quality of life Five Dimensions, EQ-5D-3L) 3. Well-being (The short form of the Mental Health Continuum, MHC-SF) 4. Psychological flexibility (The Comprehensive assessment Acceptance and Commitment Therapy processes, CompACT) |
| Overall study start date | 01/01/2020 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | A sample size of 12 clusters per treatment arm (total number of clusters=24) with 10 individuals per cluster (total sample size 240) |
| Key inclusion criteria | 1. Diagnosis of MS 2. Age ≥ 18 years 3. Written informed consent 4. Resilience score < 83 5. Able to attend group sessions and fluent Italian speaker |
| Key exclusion criteria | 1. Severe cognitive compromise (Mini Mental State Examination <19) 2. Psychosis or other serious psychiatric conditions 3. Psychotherapy in the preceding six months 4. Prior formal training in mindfulness methods or current meditation practice 5. Severe suicidality, including ideation, plan and intent 6. One or more relapses in the previous month 7. Corticosteroid treatment during the previous month 8. Other serious medical disorders in addition to MS 9. Current pregnancy 10. MS diagnosis for less than three months |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 31/03/2022 |
Locations
Countries of recruitment
- Italy
Study participating centres
Centro Sclerosi Multipla
Via Celoria 11
Milan
20133
Italy
Circonvallazione Gianicolense, 87
Roma
00149
Italy
Genova
16149
Italy
Via S. Sofia, 78
Catania
95123
Italy
Via Napoleona 60
Como
22100
Italy
Divisione di Neurologia Generale
Via Mondino, 2
Pavia
27100
Italy
via Massimo Arcamone
Foligno
06034
Italy
Clinica Neurologica
Piazzale Giorgio Menghini, 1
Perugia
06129
Italy
Sponsor information
Research organisation
Department of Research and Clinical Development
Scientific Directorate
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milano
20133
Italy
| Phone | +39 (0)2 2394 3568 |
|---|---|
| crc@istituto-besta.it | |
| Website | http://www.istituto-besta.it |
"ROR" |
https://ror.org/05rbx8m02 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Italian Multiple Sclerosis Foundation, Italian MS Foundation, FISM
- Location
- Italy
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Ambra Mara Giovannetti (ambra.giovannetti@istituto-besta.it). Data will be available after publication once the research team will end the dissemination process. People interested in receiving the data will need to ask and present a specific project on data use and ask the study SC for the approval. The person interested in using data will be in charge for obtaining the consent from participants for that specific use of the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 02/05/2022 | 03/05/2022 | Yes | No |
Editorial Notes
03/05/2022: Publication reference added.
09/04/2021: The following changes have been made:
1. The recruitment start date has been changed from 12/10/2020 to 01/09/2021.
2. The recruitment end date has been changed from 31/03/2021 to 31/03/2022.
3. The overall trial end date has been changed from 31/12/2021 to 31/12/2022.
4. The intention to publish date has been changed from 31/03/2022 to 31/03/2023.
5. The ethics approval has been updated.
6. The secondary outcome measures have been updated.
7. The plain English summary has been updated to reflect the changes above.
20/10/2020: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/09/2020 to 12/10/2020.
2. The recruitment end date was changed from 31/01/2021 to 31/03/2021.
3. The overall end date was changed from 30/09/2021 to 31/12/2021.
4. The intention to publish date was changed from 31/12/2021 to 31/03/2022.
5. The plain English summary was updated to reflect these changes.
14/05/2020: Trial’s existence confirmed by Ethics committees of the Fondazione IRCCS Istituto Neurologico Carlo Besta.
