Meditation for people with amyotrophic lateral sclerosis and their caregivers
| ISRCTN | ISRCTN88066803 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88066803 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/12/2015
- Registration date
- 11/12/2015
- Last edited
- 05/09/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease (after a famous baseball player who suffered from it), is a serious condition which affects the nervous system. When a person is suffering from ALS, the nerve cells in the brain and spinal cord which control the movement of muscles (motor neurons) are gradually lost (neurodegeneration). The disease often begins with muscle twitching and weakness in the arms or legs, leading to paralysis and death, when the main muscle involved in breathing (diaphragm) is also paralysed. A diagnosis of ALS can be extremely distressing for patients, and people who are diagnosed often experience worry about their future to such an extent that they experience mental health problems such as anxiety and depression. Mindfulness is a concept designed to help people to be more aware of their thoughts and feelings in order to become more self-aware and accepting of the current moment. Its use in the treatment of people suffering from mental health problems is steadily increasing, and new techniques are being developed to help people with different problems. Mindfulness-based stress reduction (MBSR) is a programme which has been developed using the concept of mindfulness in order to help people living with pain and long-term health conditions. The aim of this study is to find out whether a MBSR programme involving mediation exercises specifically designed for people with ALS can help to improve quality of life.
Who can participate?
Adults suffering from ALS who are able to speak and are in control of their mental faculties.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group being an 8-week course of Mindfulness-Based Stress Reduction. This involves weekly sessions run by two trained facilitators, teaching meditative exercises such as breathing and relaxation training, group discussions about how to accept emotions and increasing awareness of the body. Participants in the second group continue to receive standard care throughout the 8 weeks. These participants are also given the option of receiving counselling sessions for additional support. At the start of the study, and then again at 3, 6 and 12 months, participants in both groups complete a number of questionnaires in order to test their quality of life, any feelings of anxiety or depression and mindfulness.
What are the possible benefits and risks of participating?
Participants may benefit from feeling better emotionally thanks to the mindfulness training. There are no notable risks of taking part in this study.
Where is the study run from?
Niguarda Ca' Granda Hospital (Italy)
When is the study starting and how long is it expected to run for?
December 2011 to November 2015
Who is funding the study?
Ministry of Health (Italy)
Who is the main contact?
Dr Francesco Pagnini
Contact information
Scientific
Università Cattolica del Sacro Cuore
Via Nirone 15
Milan
20123
Italy
 ORCID ID |
0000-0003-1612-4211 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | The effect of a psychological intervention for people with amyotrophic lateral sclerosis and their caregivers on their quality of life: Mediation compared to usual care |
| Study objectives | Meditation training designed for people with ALS can improve their quality of life. |
| Ethics approval(s) | Niguarda Hospital Ethics Committee, 30/05/2012, ref: 190_05/2012 |
| Health condition(s) or problem(s) studied | Amyotrophic lateral sclerosis (ALS) |
| Intervention | Participants are randomly allocated to one of two groups. Intervention group: Participants take part in weekly sessions of Mindfulness-Based Stress Reduction adapted for people with ALS for 8 weeks. Each sessions lasts for 1.5-2 hours, and involves meditative exercises such as body scan, breathing and relaxation training, group discussions about emotions and how to accept them and other cognitive tasks that facilitated the awareness of being in the moment with no judgement. Control group: Participants receive standard care throughout the 8 week study period. Standard care referred to a multidisciplinary approach, which also included the chance of psychological support when needed. Depending on the patient’s needs, psychological support can include up to 8 counselling sessions. After the 8 week study period, all participants joined post-intervention assessments and follow-up, at 6 and 12 months from the recruitment. |
| Intervention type | Behavioural |
| Primary outcome measure | Quality of life is assessed using the ALS-Specific Quality of Life Revised (ALSSQoL-r) at baseline, 3, 6 and 12 months. |
| Secondary outcome measures | 1. Anxiety and Depression measured using the Hospital Anxiety and Depression Scale at baseline, 3, 6, and 12 months 2. Mindfulness is measured using the Five Facet Mindfulness Questionnaire at baseline, 3, 6, and 12 months |
| Overall study start date | 01/12/2011 |
| Completion date | 28/02/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Aged 18 years or over 2. Probable or definite ALS diagnosis within 6 months of recruitment 3. Ability to speak and comprehend 4. A caregiver identified as the person who provided the most of care and assistance (e.g. a close relative) |
| Key exclusion criteria | 1. Co-morbidity 2. History of psychiatric illness |
| Date of first enrolment | 30/05/2012 |
| Date of final enrolment | 30/11/2014 |
Locations
Countries of recruitment
- Italy
Study participating centre
Piazza dell'Ospedale Maggiore 3
Milan
20123
Italy
Sponsor information
Hospital/treatment centre
L.go Ca' Granda 3
Milan
20123
Italy
"ROR" |
https://ror.org/00htrxv69 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Italian Ministry of Health, Italy Ministry of Health, Ministry of Health of Italy, Ministry of Health - Italy, Ministry of Health, Italy
- Location
- Italy
Results and Publications
| Intention to publish date | 28/02/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned submission of results for publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2017 | Yes | No |
Editorial Notes
05/09/2018: Publication reference added.
04/11/2016: The overall trial end date has been updated from 30/11/2015 to 28/02/2017.
31/05/2016: The publication and dissemination plan has been updated.
