Psychological Therapy for Patients With ALS

NCT03975608 | Completed

• 1 other identifier: ALS_Pilot
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis; Psychological Stress

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Level of 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 at three time points: before the intervention, immediately after the intervention and 3 months after the intervention

• Level of functioning

  Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention

Study Arms (1)

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.

Behavioral: Adaptation of "CALM"

Interventions

Adaptation of "CALM" BEHAVIORAL

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.

Adaptation of "CALM"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University Medical Center Leipzig

Leipzig, Saxony, 04103, Germany

Location

Related Publications (1)

• 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. 2025 Nov 12. doi: 10.1055/a-2711-2085. Online ahead of print. German.

  PMID: 41224202 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Stress, Psychological

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Study Officials

• Anja Mehnert-Theuerkauf, Prof. Dr.

  University of Leipzig

  PRINCIPAL INVESTIGATOR

• Joseph Claßen, Prof. Dr.

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Medical Psychology and Medical Sociology

Model Details: 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).

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 5, 2019
• Study Start: February 11, 2019
• Primary Completion: October 31, 2020
• Study Completion: November 15, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)