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Psychological assessments in people with ALS and their caregivers' burden

Studies how people with ALS feel about being a burden to caregivers.

Key facts

Who runs it
Assistance Publique Hopitaux De Marseille
Where
Marseille, FranceSee the site
Trial code
Registry title
Anticipated Patient and Caregiver Burden
Status
Recruiting
People taking part
126 people, planned
Started
22 Jun 2023
Expected to end
22 Jun 2027
Type of study
Interventional
Treatments tested
  • Psychological assessments
Record updated
29 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with ALS who need help from others in daily life, together with their main family caregiver living at home.

Age
Patients and caregivers: at least 18 years old.
Sex
All sexes can join.
Disease stage
ALS with a motor handicap of grade 3 to 5 on the Rankin score; diagnosed at least 6 months ago; the patient must be aware of how serious the illness is.
Earlier treatment
The patient has already had at least two multidisciplinary assessments in the ALS center in Marseille, including an evaluation by the clinical psychologist.

Main reasons for not taking part

  • Patient with a serious and unstable heart, cancer, liver, kidney or psychiatric illness (schizophrenia, bipolar)
  • Patient who is independent (Rankin 0 to 2), or who lives alone or in an institution
  • Patient with cognitive impairment that interferes with daily life, or with marked emotional lability (spasmodic crying)
  • Patient diagnosed less than 6 months ago
  • Caregiver with a severe and unstable illness or a history of psychiatric illness

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Patient is at least 18 years of age
  • Patient having given informed consent
  • Patient with ALS who has already had at least two multidisciplinary assessments in the ALS center in Marseille with an evaluation by the clinical psychologist
  • Patient with a motor handicap of grade 3 to 5 on the Rankin score
  • Patient with a primary family caregiver at home (spouse, child) willing to participate in the study
  • Patient who is a beneficiary of or affiliated with a social security plan
  • Adult subject at least 18 years of age
  • Subject who has given informed consent
  • Primary family caregiver of a patient with ALS who agrees to participate in the study
  • Caregiver present during hospital visits

Who cannot take part

  • Patients with a serious and unstable associated disease, cardiac, oncological, hepatic or renal, psychiatric (schizophrenia, bipolar)
  • Patient with cognitive impairment that interferes with activities of daily living
  • Patients who have had a recent diagnosis of their disease (less than 6 months)
  • Patients who are unaware of the severity of their condition
  • Any condition that in the opinion of the investigator or psychologist would not be compatible with the study
  • Subjects with severe and unstable cardiac, oncological, hepatic, renal or other illnesses
  • Subject with a history of psychiatric illness
  • Autonomous patient, who does not need the help of a third party for the basic gestures of daily life (Rankin 0 to 2)
  • Patient living in an institution or alone at home
  • Patients with marked emotional lability (spasmodic crying) due to ALS

Where in France

  • Service Maladies neuromusculaires et SLAMarseille, FranceContact: Annie VerschuerenTaking people

About the trial

What the trial wants to find out

Amyotrophic lateral sclerosis (ALS) is a degenerative neurological disease that causes progressive motor disability and is life threatening within a few years. The severity of the disease, the progressive loss of autonomy that leads to dependence on family and caregivers, and the lack of effective treatment sometimes leads patients to a loss of hope and to dark thoughts. The prevalence of suicidal ideation is high, with more than one third of people with ALS experiencing it. The psychological suffering of patients is often associated with that of their caregivers. The evaluation of the patients' feeling of being a burden has rarely been addressed in previous studies in ALS on the notion of burden. In this work, the investigators wish to evaluate the patient's ideas of death by also taking into account the caregiver's burden and the patient's feeling of being a burden. They wish to better understand this difficult experience by refocusing the study on the patient himself, which has rarely been addressed in studies on ALS and the notion of burden. By working on the caregiver's burden, both from the caregiver's point of view and as perceived by the patient, the investigators hope to find avenues of intervention and define actions that could help patients and their families and improve the quality of life of the patient-caregiver couple.

The group in the trial

  • Psychological assessmentsTreatment being tested

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Anticipated Patient and Caregiver Burden: Impact in People With Amyotrophic Lateral Sclerosis
Plain-language title
Psychological assessments in people with ALS and their caregivers' burdenGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
29 October 2026