Amyotrophic Lateral SclerosisNCT03975608
Psychological Therapy for Patients With ALS
A study testing Adaptation of "CALM" in people with Amyotrophic Lateral Sclerosis and Psychological Stress, run by University of Leipzig at 1 site in Germany.
Trial summary
Amyotrophic lateral sclerosis (ALS) is a disease that is inevitably fatal. To be diagnosed with a terminal illness such as ALS deeply affects one's personal existence and goes along with significant changes regarding the physical, emotional, and social domains of the patients' life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Psychological Stress
- What is being tested?
- Adaptation of "CALM"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 11 Feb 2019to 15 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- confirmed diagnosis of Amyotrophic Lateral Sclerosis
- minimum age of 18 years
- fluent in German language
- ability to visit the institution providing the intervention at the start of therapy (in the course of treatment, telephone-sessions may be offered)
- ability to report on thoughts and feelings (by speaking, writing or via communication devices)
- cognitive ability to give written informed consent
- expected remaining lifetime of at least 9 months
Who cannot join
- inability for communicate (neither via speaking, writing or communication devices)
- currently in psychotherapeutic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation of a Psychological Therapy for Patients With ALS - a Pilot Study
Amyotrophic lateral sclerosis (ALS) is a disease that is inevitably fatal. To be diagnosed with a terminal illness such as ALS deeply affects one's personal existence and goes along with significant changes regarding the physical, emotional, and social domains of the patients' life. This pilot study will test a manualized, individual psychotherapeutic intervention to relieve distress and promote psychological well-being in ALS patients. A total of 5 patients will receive the intervention. The investigators will gather important information regarding the feasibility of the intervention (i.e., response rate, patient and therapist adherence, and patient satisfaction), which may be used for conducting a future randomized controlled trial. Various domains of quality of life will be assessed before the intervention (T0), after the intervention (T1) and at 3-months-follow-up (T2) in order to test for preliminary efficacy of the intervention.
Read the detailed description
Background: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that is inevitably fatal. To be diagnosed with a terminal illness such as ALS deeply affects one's personal existence and goes along with significant changes regarding the physical, emotional, and social domains of the patients' life. ALS patients have to face a rapidly debilitating physical decline which restrains mobility and impairs all activities of daily living. In addition, they are confronted with their own mortality. This progressive loss of autonomy and fears about the future may lead to a sense of hopelessness and loss of quality of life, which in turn may even result in thoughts about physician-assisted suicide.
Concrete aims: Given the high emotional strain in this patient group, this study aims to apply a manualized psychotherapeutic intervention to relieve distress and promote psychological well-being on ALS patients. This short-term intervention (up to six sessions) was originally developed for advanced cancer patients. "Managing Cancer and Living Meaningfully (CALM)" focuses on the four dimensions: (i) symptom management and communication with healthcare providers, (ii) changes in self and relations with close others, (iii) spirituality, sense of meaning and purpose and (iv) thinking of the future, hope, and mortality.
Methodology: For these aims mentioned above, the investigators will conduct a feasibility study, i.e., a pilot study before a future randomized controlled trial can be planned in detail. The design of this pilot intervention will be a non-randomised prospective non-controlled before-and-after study, in which observations will be made only in a patient group (n = 5) that receives the intervention (IG). No control group will be recruited. Assessments will be conducted on the three measurement points: before the therapy (T0), after the intervention (T1) and 3 months after the intervention (T2).This study is intended to test out the standard operating procedures, evaluate the feasibility, acceptance and adherence to the study protocol as well as preliminary efficacy of the intervention.
Recruitment: Patients will be consecutively recruited in the Clinic of Neurology at the University Medical Center of Leipzig.
Duration: The duration for patients will be about 9 months (6 months intervention, 3 month-follow-up assessment). The duration of the whole study will be 12 months.
- Being tested
- Adaptation of "CALM"
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptation of "CALM"Behavioural
The therapy is built up by 3-8 sessions (duration about 45-60 min) over a period of 6 months. All dimensions are explored with every patient, but the order and extent of each dimension are adapted to the individual needs of the patient.
The sessions address the 4 dimensions of the original program designed for palliative cancer patients:
- Symptom management and communication with healthcare providers
- Changes in self and relations with each others
- Spirituality, sense of meaning, and purpose
- Thinking of the future, hope, and mortality
As an adaptation, the investigators will especially focus on two other aspects which take into account the specific symptoms and challenges in patients with ALS: (i) communication skills and (ii) emotional expression and control.
| Study group | Role | What they receive |
|---|---|---|
| Adaptation of "CALM" | Experimental | This is the patient group that receives the intervention (IG), i.e., the psychotherapeutic treatment, i.e., the adapted version of the psychotherapeutic program "Managing Cancer and Living Meaningfully (CALM)" which was originally designed for patients with cancer. Receives: Behavioral: Adaptation of "CALM" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
The investigators will assess the amount of eligible patients which are willing to participate in the study relative to the amount of patients who were invited to participate.
Measured: The assessment period for this outcome will be from the start of recruitment until the inclusion of the last patient, which will be about 1 year.
Patient adherence
Patient adherence will be assessed via documentation of patient drop-outs. In detail, we will document whether patients leave the study during the treatment (and if yes, at what stage).
Measured: During the intervention phase for each patient, which will be about sixth months.
Patient satisfaction
Assessed by a questionnaire (Working Alliance Inventory - short form revised). The total sum score across the 12 items, rated on a five-point Likert scale, will be presented (ranging from 12 to 60). Higher values present higher satisfaction.
Measured: Assessed only once for each patient, immediately after the patient has completed the intervention.
Secondary outcomes (3)
Level of quality of life
Assessed by a questionnaire, the Amyotrophic Lateral Sclerosis Assessment Questionnaires - short form (ALSAQ-5). The total score across the 5 items, rated on a 4-point Likert scale, will be presented (range: 0 - 20). Higher values indicate higher quality of life.
Measured: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
Level of depressive symptomatology
Assessed by a questionnaire, the ALS-Depression-Inventory (ADI-12). The sum score across all 12 items, each rated on a 4-point Likert-scale, will be reported (range: 12-48). Higher values indicate higher levels of depression.
Measured: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
Level of functioning
Assessed by a questionnaire, the revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R). The total sum score across the 15 items, each rated on a 5-point LIkert scale, will be reported (range: 0-60). Higher values indicate a higher level of functioning.
Measured: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start11 Feb 2019
- Primary completion31 Oct 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- 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
- Model description
- The design of this project will be a non-randomised and non-controlled before-and-after study in which observations will be made only in a patient group that receives the intervention. No control group will be recruited. Assessments will be conducted at three measurement points: T0 (before the intervention), T1 (at the end of the intervention), T2 (3 months after T1).
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Mehnert, University of Leipzig
- Investigators
- Anja Mehnert-Theuerkauf, Prof. Dr., Principal investigator, University of LeipzigJoseph Claßen, Prof. Dr., Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975608
- Sponsor's protocol ID
- ALS_Pilot
- Status last verified
- Apr 2021
- First submitted
- 23 May 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Metelmann M, Heyne S, Peuker M, Classen J, Mehnert-Theuerkauf A, Esser P. [Experiences with the Application of Short-Term Psychotherapy in Patients with Amyotrophic Lateral Sclerosis: What Can We Learn from It?]. Psychother Psychosom Med Psychol. 2026 Feb;76(2):86-94. doi: 10.1055/a-2711-2085. Epub 2025 Nov 12. German.
PubMed 41224202
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of a Psychological Therapy for Patients With ALS - a Pilot Study
- ClinicalTrials.gov ID
- NCT03975608
- Acronym / sponsor ID
- ALS_Pilot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 5 Jun 2019 (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 disease that is inevitably fatal. To be diagnosed with a terminal illness such as ALS deeply affects one's personal existence and goes along with significant changes regarding the physical, emotional, and social domains of the patients' life. This pilot study will test a manualized, individual psychotherapeutic intervention to relieve distress and promote psychological well-being in ALS patients. A total of 5 patients will receive the intervention. The investigators will gather important information regarding the feasibility of the intervention (i.e., response rate, patient and therapist adherence, and patient satisfaction), which may be used for conducting a future randomized controlled trial. Various domains of quality of life will be assessed before the intervention (T0), after the intervention (T1) and at 3-months-follow-up (T2) in order to test for preliminary efficacy of the intervention.
Detailed description
Background: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that is inevitably fatal. To be diagnosed with a terminal illness such as ALS deeply affects one's personal existence and goes along with significant changes regarding the physical, emotional, and social domains of the patients' life. ALS patients have to face a rapidly debilitating physical decline which restrains mobility and impairs all activities of daily living. In addition, they are confronted with their own mortality. This progressive loss of autonomy and fears about the future may lead to a sense of hopelessness and loss of quality of life, which in turn may even result in thoughts about physician-assisted suicide.
Concrete aims: Given the high emotional strain in this patient group, this study aims to apply a manualized psychotherapeutic intervention to relieve distress and promote psychological well-being on ALS patients. This short-term intervention (up to six sessions) was originally developed for advanced cancer patients. "Managing Cancer and Living Meaningfully (CALM)" focuses on the four dimensions: (i) symptom management and communication with healthcare providers, (ii) changes in self and relations with close others, (iii) spirituality, sense of meaning and purpose and (iv) thinking of the future, hope, and mortality.
Methodology: For these aims mentioned above, the investigators will conduct a feasibility study, i.e., a pilot study before a future randomized controlled trial can be planned in detail. The design of this pilot intervention will be a non-randomised prospective non-controlled before-and-after study, in which observations will be made only in a patient group (n = 5) that receives the intervention (IG). No control group will be recruited. Assessments will be conducted on the three measurement points: before the therapy (T0), after the intervention (T1) and 3 months after the intervention (T2).This study is intended to test out the standard operating procedures, evaluate the feasibility, acceptance and adherence to the study protocol as well as preliminary efficacy of the intervention.
Recruitment: Patients will be consecutively recruited in the Clinic of Neurology at the University Medical Center of Leipzig.
Duration: The duration for patients will be about 9 months (6 months intervention, 3 month-follow-up assessment). The duration of the whole study will be 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The design of this project will be a non-randomised and non-controlled before-and-after study in which observations will be made only in a patient group that receives the intervention. No control group will be recruited. Assessments will be conducted at three measurement points: T0 (before the intervention), T1 (at the end of the intervention), T2 (3 months after T1).
| Arm | Type | Receives |
|---|---|---|
| Adaptation of "CALM" | Experimental | Behavioral: Adaptation of "CALM"This is the patient group that receives the intervention (IG), i.e., the psychotherapeutic treatment, i.e., the adapted version of the psychotherapeutic program "Managing Cancer and Living Meaningfully (CALM)" which was originally designed for patients with cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- confirmed diagnosis of Amyotrophic Lateral Sclerosis
- minimum age of 18 years
- fluent in German language
- ability to visit the institution providing the intervention at the start of therapy (in the course of treatment, telephone-sessions may be offered)
- ability to report on thoughts and feelings (by speaking, writing or via communication devices)
Key exclusion criteria (2 listed)
- inability for communicate (neither via speaking, writing or communication devices)
- currently in psychotherapeutic treatment
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 |
|---|---|---|
| Adaptation of "CALM"The therapy is built up by 3-8 sessions (duration about 45-60 min) over a period of 6 months. All dimensions are explored with every patient, but the order and extent of each dimension are adapted to the individual needs of the patient. The sessions address the 4 dimensions of the original program designed for palliative cancer patients: 1. Symptom management and communication with healthcare providers 2. Changes in self and relations with each others 3. Spirituality, sense of meaning, and purpose 4. Thinking of the future, hope, and mortality As an adaptation, the investigators will especially focus on two other aspects which take into account the specific symptoms and challenges in patients with ALS: (i) communication skills and (ii) emotional expression and control. | Behavioural | Adaptation of "CALM" |
Primary outcome
Response rate
Time frame: The assessment period for this outcome will be from the start of recruitment until the inclusion of the last patient, which will be about 1 year.
The investigators will assess the amount of eligible patients which are willing to participate in the study relative to the amount of patients who were invited to participate.
Patient adherence
Time frame: During the intervention phase for each patient, which will be about sixth months.
Patient adherence will be assessed via documentation of patient drop-outs. In detail, we will document whether patients leave the study during the treatment (and if yes, at what stage).
Patient satisfaction
Time frame: Assessed only once for each patient, immediately after the patient has completed the intervention.
Assessed by a questionnaire (Working Alliance Inventory - short form revised). The total sum score across the 12 items, rated on a five-point Likert scale, will be presented (ranging from 12 to 60). Higher values present higher satisfaction.
3 secondary outcomes
Level of quality of life
Time frame: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
Level of depressive symptomatology
Time frame: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
Level of functioning
Time frame: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 41224202Metelmann M, Heyne S, Peuker M, Classen J, Mehnert-Theuerkauf A, Esser P. [Experiences with the Application of Short-Term Psychotherapy in Patients with Amyotrophic Lateral Sclerosis: What Can We Learn from It?]. Psychother Psychosom Med Psychol. 2026 Feb;76(2):86-94. doi: 10.1055/a-2711-2085. Epub 2025 Nov 12. German.
- 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. This study is not recruiting at the moment.
Anja Mehnert-Theuerkauf, Prof. Dr. principal investigator
University of Leipzig
Joseph Claßen, Prof. Dr. principal investigator
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptation of "CALM" in people with Amyotrophic Lateral Sclerosis and Psychological Stress, run by University of Leipzig at 1 site in Germany.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 28 Apr 2021. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: The assessment period for this outcome will be from the start of recruitment until the inclusion of the last patient, which will be about 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03975608, which also lists 1 linked publication.
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 28 Apr 2021.