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potentiALS - Quality of Life Among Patients With Amyotrophic Lateral Sclerosis

NCT06441448 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2024-06-04

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Leipzig University Medical Center

    collaborator OTHER

  • University of Leipzig

    lead OTHER

Principal Investigators

  • Moritz Metelmann, PhD · Universitätsklinikum Leipzig

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-08-31
Completion
2024-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06441448 on ClinicalTrials.gov