Clinical trial NCT03975608: Psychological Therapy for Patients With ALS
Official title: Adaptation of a Psychological Therapy for Patients With ALS - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Psychological Stress
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* inability for communicate (neither via speaking, writing or communication devices)
* currently in psychotherapeutic treatment

Primary outcomes:
measure: Response rate
timeFrame: 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.
measure: Patient adherence
timeFrame: During the intervention phase for each patient, which will be about sixth months.
measure: Patient satisfaction
timeFrame: Assessed only once for each patient, immediately after the patient has completed the intervention.
Secondary outcomes:
measure: Level of quality of life
timeFrame: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
measure: Level of depressive symptomatology
timeFrame: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
measure: Level of functioning
timeFrame: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Medical Center Leipzig
state: Saxony
Study officials:
affiliation: University of Leipzig
name: Anja Mehnert-Theuerkauf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leipzig
name: Joseph Claßen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: