READY for MS, a group intervention to promote resilience in people with multiple sclerosis in Italy

Italian set up of the program “REsilience and Activity every DaY for MS”, of outcomes, and pilot assessment of efficacy using a mixed methodology.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38971970

Enrollment

Registered

2018-06-04

Start date

2017-03-16

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Resilience in people with multiple sclerosis Nervous System Diseases Multiple sclerosis

Interventions

Interventions Each group will be composed of 8-10 participants, a total of 4 groups will be performed (2 “READY for MS”, and 2 relaxation

within each arm, the two groups will be homogeneously assembled so that the participants will be as homogeneous as possible in terms of their EDSS score). 1. “READY for MS”: This is an adult resilien

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of MS 2. Aged >=18 years 3. Signed informed consent 4. The Connor-Davidson Resilience Scale (CDRISC-25) score <83, which indicates that the person could still improve his/her level of resilience) 5. Able to attend the program group sessions (8 sessions, each lasting 2.5 hours) 6. Fluent Italian speaker

Exclusion criteria

Exclusion criteria: 1. Severe cognitive compromise (MMSE <19) 2. Psychotherapy ongoing or in the preceding 6 months 3. Previous experience in meditation or other mind-body therapies 4. Major psychiatric disorders (including psychotic disorders or active substance abuse problems) 5. Pregnancy 6. MS diagnosis for less than 3 months 7. One or more relapses of MS in the last month.

Design outcomes

Primary

Measure	Time frame
The MSQOL-54 is a health-related quality of life (QoL) measure that comprises the generic Short-Form 36-item (SF-36), plus 18 MS-specific items. The 54 items are organized into 12 multi-item and two single item subscales. As for SF-36, two composite scores (Physical Health Composite [PHC] and Mental Health Composite [MHC]) are derived by combining scores of the relevant subscales. The MSQOL-54 has well documented validity in terms of content, constructs, reliability, discrimination, and responsiveness. To limit multiple comparisons, we will primarily assess changes in PHC and MHC.	—

Measure

Time frame

The MSQOL-54 is a health-related quality of life (QoL) measure that comprises the generic Short-Form 36-item (SF-36), plus 18 MS-specific items. The 54 items are organized into 12 multi-item and two single item subscales. As for SF-36, two composite scores (Physical Health Composite [PHC] and Mental Health Composite [MHC]) are derived by combining scores of the relevant subscales. The MSQOL-54 has well documented validity in terms of content, constructs, reliability, discrimination, and responsiveness. To limit multiple comparisons, we will primarily assess changes in PHC and MHC.

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Secondary

Measure	Time frame
1. Mood assessed using the Hospital Anxiety and Depression Scale (HADS), a well-validated measure that consists of two seven-item subscales to assess anxiety and depressive levels. Higher scores indicate higher level of depressive or anxiety symptoms. Unlike a number of other measures, the HADS excludes somatic symptoms of anxiety and depression, which may overlap with physical illness . 2. Stress assessed using the 10-item version of the Perceived Stress Scale (PSS) will be used to assess the extent to which life situations are appraised as stressful. Higher score indicates higher level of stress perceived. 3. Psychological resilience assessed using the Connor-Davidson Resilience Scale (CDRISC-25). It is composed of 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience. The scale demonstrated good psychometric properties. 4. Psychological flexibility assessed using the CompACT scale consisting of 23 items, each rated on a 0-6 Likert scale and grouped in three scales (openness to experience, behavioral awareness, and valued action). A total score is calculated as the sum of the three subscale scores (range 0-138, higher values indicating greater psychological flexibility). The CompACT demonstrated good internal consistency, and converged and diverged in theory-consistent ways with other measured variables: higher levels of psychological inflexibility were associated with higher levels of distress and lower levels of health and wellbeing. 5. Mindfulness assessed using the Mindful Attention Awareness Scale (MAAS), a 15-item scale aimed to assess a core characteristic of dispositional mindfulness across interpersonal cognitive, physical, emotional, and general domains. Items are rated on a 6-point Likert scale, and responses are then summed with higher scores indicating a greater presence of mindfulness. The MAAS has validity, internal reliability and sensitivity to change. 6. Values and meaningful action assessed using the 20-	—

Measure

Time frame

1. Mood assessed using the Hospital Anxiety and Depression Scale (HADS), a well-validated measure that consists of two seven-item subscales to assess anxiety and depressive levels. Higher scores indicate higher level of depressive or anxiety symptoms. Unlike a number of other measures, the HADS excludes somatic symptoms of anxiety and depression, which may overlap with physical illness . 2. Stress assessed using the 10-item version of the Perceived Stress Scale (PSS) will be used to assess the extent to which life situations are appraised as stressful. Higher score indicates higher level of stress perceived. 3. Psychological resilience assessed using the Connor-Davidson Resilience Scale (CDRISC-25). It is composed of 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience. The scale demonstrated good psychometric properties. 4. Psychological flexibility assessed using the CompACT scale consisting of 23 items, each rated on a 0-6 Likert scale and grouped in three scales (openness to experience, behavioral awareness, and valued action). A total score is calculated as the sum of the three subscale scores (range 0-138, higher values indicating greater psychological flexibility). The CompACT demonstrated good internal consistency, and converged and diverged in theory-consistent ways with other measured variables: higher levels of psychological inflexibility were associated with higher levels of distress and lower levels of health and wellbeing. 5. Mindfulness assessed using the Mindful Attention Awareness Scale (MAAS), a 15-item scale aimed to assess a core characteristic of dispositional mindfulness across interpersonal cognitive, physical, emotional, and general domains. Items are rated on a 6-point Likert scale, and responses are then summed with higher scores indicating a greater presence of mindfulness. The MAAS has validity, internal reliability and sensitivity to change. 6. Values and meaningful action assessed using the 20-

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026