READY for MS, a group intervention to promote resilience in people wit
Italian set up of the program “REsilience and Activity every DaY for MS”, of outcomes, and pilot assessment of efficacy using a mixed methodology.
What it found
A paper reports the results; we have not read it yet. See Papers below.
What it measured
Main measures
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
Quality of life (reported by participants)
Other measures (1)
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
Disability progressionRelapsesMRI lesionsThinking and memoryWalking and mobilityBladder, bowel and sexual functionMood and sleepQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
Inclusion: 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: 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.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims : Living with multiple sclerosis (MS) can be a consistent source of stress. Targeted intervention aimed at promoting personal resilience (an individual's ability to adapt in the face of adverse conditions) can alleviate the adverse effects of stress and sustain good quality of life (QoL). The Acceptance and Commitment Therapy (ACT) is a third wave cognitive behavioural therapy, specifically aimed at promoting psychological flexibility, the key ingredient of resilience. Pakenham et al. created a highly structured group intervention based on ACT and called “The READY (REsilience and Activity for every DaY) program”. It has also been specifically adapted for people with MS (READY for MS). The aim of this study is to evaluate how well READY for MS program works, if compared to a relaxation intervention. Who can participate? People with a diagnosis of MS for more than three months, aged 18 and over, with a level of resilience that could still improve, and able to attend the program group sessions, will be invited to participate in the study. What does the study involve? Participants have the same chance of being placed in either group: READY for MS or relaxation. Both the treatments consist of 8 group sessions with 7 weekly sessions plus a booster session 5 weeks later and will be conducted by the same psychologist. In the READY for MS each session will last 2.5 hours. All the sessions incorporates a blend of psychoeducation and experiential exercises, combined with readings and homework exercises that participants are encouraged to practice between sessions. In the relaxation program each session will last 1 hour. The facilitator will guide the group through a series of relaxation exercises. Each session will finish with a debriefing about the experience. Participants are encouraged to practice between sessions. At the end of follow-up, people that participate in the relaxation group will have the opportunity to participate in the READY for MS. What are the possible benefits and risks of participating? We do not expect any negative effects by participating in this study. In addition, we will carefully monitor participants’ psychological condition and if necessary advise the participant about possible treatment options. Moreover, Pakenham and colleagues found that “READY for MS” improves quality of life and resilience in people with multiple sclerosis. Those assigned to the relaxation group, will learn specific relaxation skills and techniques. Where is the study run from? Foundation IRCCS Neurological Institute C. Besta (Italy) When is study starting and how long is it expected to run for? February 2017 to July 2018 Who is the main contact? Ambra Mara Giovannetti ambra.giovannetti@istituto-besta.it
Papers
Results
results
Loading reviews and guidelines…
History
Started
Mar 2017
Finished
Jul 2018