potentiALS - Quality of Life Among Patients With Amyotrophic Lateral Sclerosis

NCT ID: NCT06441448

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-31

Brief Summary

Amyotrophic lateral sclerosis (ALS) is a rapidly progressing and disabling disease with the majority of patients dying 3-5 years after symptom onset. Given the high symptom burden, many patients and its caregivers are highly distressed. However, few programs to improve mental health for this patient group exist, and the sparse research implies that programs effective in other medical conditions may not be feasible in ALS patients. Therefore, it is highly needed to involve ALS patients, caregivers and medical staff as contributors into the development of such programs to meet the needs they really have.

The envisaged project has two aims: First, the investigators want to examine whether and how it is possible to involve ALS patients in the whole research process despite rapid disease progress and severe functional impairments. Second, the investigators are interested in how contributors (i.e., patients, caregivers and medical staff) would compile a concrete psychotherapeutic program, i.e., how they set priorities in terms of format, content and treatment techniques of such a program.

The investigators will closely collaborate with contributors across the whole project in designing the research process, planning assessment as well as interpreting and disseminating the findings. At the end of the study, the investigators will gather contributor feedback on their experience with the participatory approach.

Results will provide important information on how ALS patients can be effectively involved in psychosocial intervention research. Identified priorites regarding psychotherapeutic programs will serve as concrete starting points to develop and test a disease-specific program within a subsequent study.

Detailed Description

Amyotrophic lateral sclerosis (ALS) is a neurogenerative multi-systemic disease with various symptoms including weakness, cramps, pain, inappropriate affect or speech problems. ALS is inevitably fatal, with the majority of patients dying within 3-5 years after symptom onset as a result of ventilatory failure.

Given the symptom burden and the fatal nature of the disease, many patients are highly distressed. ALS patients show elevated rates of depressive symptoms and impaired quality of life, and levels of anxiety increase with progressing disease. About one third of patients suffer from moderate or severe hopelessness which in turn is associated with desire for hastened death.

The mental burden warrants effective psychological treatments to improve quality of life (QoL) among this patient group. However, few psychosocial interventions studies exist whose results do not allow for strong recommendations due to issues regarding methodology and acceptability. Recently, our own working group failed to apply a psychotherapy effective in palliative cancer patients to ALS patients (publication in preparation, see https://clinicaltrials.gov/ct2/show/NCT03975608).

Therefore, concepts feasible in other populations may not meet the specific needs of ALS patients. Indeed, various disease-specific facilitators have been identified such as flexible format, diseasespecific content tailoring, fostering of patient autonomy, but also barriers such as high effort in reaching and undergoing the intervention and functional decline. Based on such findings, psychotherapeutic programs for ALS patients should be co-designed within a participatory approach to overcome problems with feasibility and acceptability. However, the investigators identified only one study applying a similar approach; however, it was placed in a complete different health care context.

The investigators herein envisage a conceptual phase closely collaborating with various contributors, i.e., patients, caregivers and medical staff. The first objective is to assess the ability and benefit in collaborating with ALS patients in psychosocial intervention research. As second objective, contributors will prioritize their needs in psychological interventions regarding format, content and techniques. Results will be used in an exploratory trial to co-design a psychotherapeutic program ensuring good feasibility and acceptability.

The research questions of the first objective are the following:

1. How high is the response rate of contributors to be involved in this participatory project?

2. Which participative methods are applicable among ALS patients or need to be adapted?

3. How do contributors evaluate the possbility to collaborate in psychosocial intervention research?

4. What are the lessons learned and how can they be transferred to participatory psychosocial intervention research among severe (neurodegenerative) diseases?

The main research questions related to the second objective are the following:

5. How do contributors prioritize treatment-related factors in format, content and techniques?

6. Which factor-specific barriers for feasibility and acceptability are anticipated by contributors?

7. What are the main findings to serve as starting point for co-designing a disease-specific treatment program within an exploratory future trial?

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

case focus groups

The study is in a monocentric, exploratory, participatory study conceptualization phase. Within the study, a mixed-methods assessment involves various interview and group exercise formats among scientists, medical personnel, affected individuals, and their caregivers to develop components for a future psychotherapeutic program for ALS patients and their caregivers. Therapists provide an overview of therapy forms by presenting components based on format, content, and applied techniques. Case studies and focus groups are used for practical experience for the participants. Participants qualitatively assess the significance of therapeutic approaches and make a quantitative prioritization to establish a ranking of therapy components.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• patients met criteria for definite/laboratory-supported probable/clinically probable/possible familial or sporadic ALS (diagnostically synonymous with MND) or MND variants (progressive muscular atrophy or primary lateral sclerosis according to the revised El Escorial criteria
• ≥ 18 years old
• fluent in German
• ability to communicate thoughts and feelings
• ability to provide written consent
• anticipated remaining lifespan of ≥ 9 months.

Exclusion Criteria

• under 18 years old
• had a clinical need for gastrostomy feeding or non-invasive ventilation
• had a diagnosis of dementia
• inability to consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leipzig University Medical Center

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Anja Mehnert

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moritz Metelmann, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Leipzig

Locations

University Medical Center Leipzig

Leipzig, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Moritz Metelmann, PhD

Role: CONTACT

moritz.metelmann@medizin.uni-leipzig.de

+49 341 97 24209

Svenja Heyne, MSc. Psych

Role: CONTACT

svenja.heyne@medizin.uni-leipzig.de

+49 341 97 15438

Facility Contacts

Moritz Metelmann, PhD

Role: primary

moritz.metelmann@medizin.uni-leipzig.de

+49 341 - 97 24209

References

Heyne S, Kuzmanova A, Esser P, Linse K, Gunther R, Mehnert-Theuerkauf A, Metelmann M. How can we reduce psychological burden for patients of amyotrophic lateral sclerosis and their family caregivers? - Insights from the participatory multi-method study "potentiALS". BMC Neurol. 2025 Oct 7;25(1):414. doi: 10.1186/s12883-025-04440-w.

Reference Type: DERIVED

PMID: 41057832 (View on PubMed)

Other Identifiers

01KG2321

Identifier Type: -

Identifier Source: org_study_id