Amyotrophic Lateral SclerosisFARPNCT05632757
Anticipated Patient and Caregiver Burden
A study testing Psychological assessments in people with Amyotrophic Lateral Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Psychological assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2023to 22 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 join
- Patients with a serious and unstable associated disease, cardiac, oncological, hepatic or renal, psychiatric (schizophrenia, bipolar)
- 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
- Patient with cognitive impairment that interferes with activities of daily living
- Patients with marked emotional lability (spasmodic crying) due to ALS
- Patients who have had a recent diagnosis of their disease (less than 6 months)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Annie Verschueren contact
France1 site, 1 recruiting
- Recruiting
Service Maladies neuromusculaires et SLA
Marseille, 13005
Annie Verschueren, annie.verschueren@ap-hm.fr
About this study
Official title: Anticipated Patient and Caregiver Burden: Impact in People With Amyotrophic Lateral Sclerosis
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Psychological assessments
- Keywords
- amyotrophic lateral sclerosis, caregiver, burden, depression
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological assessmentsBehavioural
The visit will take place during a multidisciplinary assessment in the ALS Center at the Timone Hospital, Neuromuscular Disease and ALS Department. The patient will be accompanied by his/her caregiver. During this multidisciplinary assessment, the patient is present at the hospital between 8am and 4pm. The various scales and self-questionnaires can be completed during this time. The time required to complete these scales and self-questionnaires is estimated to be about 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Psychological assessments | Experimental | Not described Receives: Behavioral: Psychological assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the patient's sense of being a burden on the patient's suicidal ideation
Columbia scale (highest score meaning better outcome)
Measured: Inclusion visit (month 0)
Secondary outcomes (17)
Relationship between the patient's feeling of being a burden living
Patient's Feelings of Burden Scale (highest score meaning worst outcome)
Measured: Inclusion visit (month 0)
Relationship between the patient's reasons for living
Patient Reasons for Living Scale (highest score meaning worst outcome)
Measured: Inclusion visit (month 0)
Relationship between the patient's feeling of being a burden and the caregiver's feeling of hardship
Patient's sense of burden scale and Zarit Caregiver Exertion Scale
Measured: Inclusion visit (month 0)
Impact of the patient's sense of burden and the caregiver's sense of hardship on the quality of life of the patient and the caregiver
WHOQOL-Bref (World Health Organization Quality of Life, highest score meaning better outcome)
Measured: Inclusion visit (month 0)
Relationship between the patient's feeling of being a burden and the motor disability
Beck scale (highest score meaning worse outcome)
Measured: Inclusion visit (month 0)
Relationship between the patient's feeling of being a burden and the motor disability
Rankin scale (highest score meaning worse outcome)
Measured: Inclusion visit (month 0)
Relationship between the patient's feeling of being a burden and the motor disability
ALSFRS score (highest score meaning better outcome)
Measured: Inclusion visit (month 0)
Relationship between the depression of patient and the caregiver
Beck scale (highest score meaning worse outcome)
Measured: Inclusion visit (month 0)
Relationship between the depression of patient and the caregiver
Rankin scale (highest score meaning worse outcome)
Measured: Inclusion visit (month 0)
Relationship between the depression of patient and the caregiver
ALSFRS score (highest score meaning better outcome)
Measured: Inclusion visit (month 0)
Impact of the caregiver's feeling of hardship on the patient's reasons for living
Patient Reasons for Living Scale (highest score meaning worst outcome)
Measured: Inclusion visit (month 0)
Impact of the caregiver's feeling of hardship on the patient's reasons for living
Columbia Scale (highest score meaning better outcome)
Measured: Inclusion visit (month 0)
Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation
Patient Reasons for Living Scale (highest score meaning worst outcome)
Measured: Inclusion visit (month 0)
Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation
Columbia Scale (highest score meaning better outcome)
Measured: Inclusion visit (month 0)
Relationship between the caregiver's perceived distress and the patient's suicidal ideation
Zarit scale (highest score meaning worse outcome)
Measured: Inclusion visit (month 0)
Relationship between the caregiver's perceived distress and the patient's suicidal ideation
Columbia Scale (highest score meaning better outcome)
Measured: Inclusion visit (month 0)
Relationship between caregiver's perceived distress and the patient's cognitive assessment
ECAS score (Cognitif Edinburgh Cognitive and Behavioural ALS Screen) (highest score meaning better outcome)
Measured: Inclusion visit (month 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start22 Jun 2023
- Primary completion22 Dec 2026 (estimated)
- Study completion22 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annie Verschueren, Principal investigator, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632757
- Sponsor's protocol ID
- RCAPHM22_0204
- Other IDs
- ID-RCB
- Acronym
- FARP
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticipated Patient and Caregiver Burden: Impact in People With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT05632757
- Acronym / sponsor ID
- FARP / RCAPHM22_0204
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- amyotrophic lateral sclerosis, caregiver, burden, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 22 Jun 2027 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychological assessments | Experimental | Behavioral: Psychological assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- Patients with a serious and unstable associated disease, cardiac, oncological, hepatic or renal, psychiatric (schizophrenia, bipolar)
- 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
- Patient with cognitive impairment that interferes with activities of daily living
- Patients with marked emotional lability (spasmodic crying) due to ALS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological assessmentsThe visit will take place during a multidisciplinary assessment in the ALS Center at the Timone Hospital, Neuromuscular Disease and ALS Department. The patient will be accompanied by his/her caregiver. During this multidisciplinary assessment, the patient is present at the hospital between 8am and 4pm. The various scales and self-questionnaires can be completed during this time. The time required to complete these scales and self-questionnaires is estimated to be about 90 minutes. | Behavioural | Psychological assessments |
Primary outcome
Impact of the patient's sense of being a burden on the patient's suicidal ideation
Time frame: Inclusion visit (month 0)
Columbia scale (highest score meaning better outcome)
17 secondary outcomes
Relationship between the patient's feeling of being a burden living
Time frame: Inclusion visit (month 0)
Relationship between the patient's reasons for living
Time frame: Inclusion visit (month 0)
Relationship between the patient's feeling of being a burden and the caregiver's feeling of hardship
Time frame: Inclusion visit (month 0)
Impact of the patient's sense of burden and the caregiver's sense of hardship on the quality of life of the patient and the caregiver
Time frame: Inclusion visit (month 0)
Relationship between the patient's feeling of being a burden and the motor disability
Time frame: Inclusion visit (month 0)
Relationship between the patient's feeling of being a burden and the motor disability
Time frame: Inclusion visit (month 0)
Relationship between the patient's feeling of being a burden and the motor disability
Time frame: Inclusion visit (month 0)
Relationship between the depression of patient and the caregiver
Time frame: Inclusion visit (month 0)
Relationship between the depression of patient and the caregiver
Time frame: Inclusion visit (month 0)
Relationship between the depression of patient and the caregiver
Time frame: Inclusion visit (month 0)
Impact of the caregiver's feeling of hardship on the patient's reasons for living
Time frame: Inclusion visit (month 0)
Impact of the caregiver's feeling of hardship on the patient's reasons for living
Time frame: Inclusion visit (month 0)
Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation
Time frame: Inclusion visit (month 0)
Impact of the caregiver's feeling of hardship on the patient's and suicidal ideation
Time frame: Inclusion visit (month 0)
Relationship between the caregiver's perceived distress and the patient's suicidal ideation
Time frame: Inclusion visit (month 0)
Relationship between the caregiver's perceived distress and the patient's suicidal ideation
Time frame: Inclusion visit (month 0)
Relationship between caregiver's perceived distress and the patient's cognitive assessment
Time frame: Inclusion visit (month 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annie Verschueren contact
Annie Verschueren principal investigator
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological assessments in people with Amyotrophic Lateral Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annie Verschueren (0491386578 ext. 33, annie.verschueren@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of the patient's sense of being a burden on the patient's suicidal ideation (time frame: Inclusion visit (month 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.