Condition category
Nervous System Diseases
Date applied
10/12/2015
Date assigned
11/12/2015
Last edited
08/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francesco Pagnini

ORCID ID

http://orcid.org/0000-0003-1612-4211

Contact details

Università Cattolica del Sacro Cuore
Via Nirone 15
Milan
20123
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

Meditation training designed for people with ALS can improve their quality of life.

Ethics approval

Niguarda Hospital Ethics Committee, 30/05/2012, ref: 190_05/2012

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/12/2011

Overall trial end date

28/02/2017

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Co-morbidity
2. History of psychiatric illness

Recruitment start date

30/05/2012

Recruitment end date

30/11/2014

Locations

Countries of recruitment

Italy

Trial participating centre

Niguarda Ca' Granda Hospital (Ospedale Niguarda Ca' Granda)
Centro Clinico NEMO Piazza dell'Ospedale Maggiore 3
Milan
20123
Italy

Sponsor information

Organisation

Niguarda Ca' Granda Hospital

Sponsor details

L.go Ca' Granda 3
Milan
20123
Italy

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Ministero della Salute

Alternative name(s)

Ministry of Health, Italy

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Italy

Results and Publications

Publication and dissemination plan

Planned submission of results for publication in a peer reviewed journal.

Intention to publish date

28/02/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.