Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06441448 |
| Other study ID # |
01KG2321 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University of Leipzig |
| Contact |
Moritz Metelmann, PhD |
| Phone |
+49 341 97 24209 |
| Email |
moritz.metelmann[@]medizin.uni-leipzig.de |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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?
