Psychological Therapy for Patients With ALS

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis; Psychological Stress
• Intervention / Treatment: Behavioral: Adaptation of "CALM"

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • University Medical Center Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	Assessed only once for each patient, immediately after the patient has completed the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention

Collaborators and Investigators

• Sponsor: University of Leipzig
• Investigators: Principal Investigator: Anja Mehnert-Theuerkauf, Prof. Dr., University of Leipzig; Principal Investigator: Joseph Claßen, Prof. Dr., University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): November 15, 2020

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Stress, Psychological
• Other Study ID Numbers: ALS_Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No