Psychological Therapy for Patients With ALS

NCT ID: NCT03975608

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-11
• Study Completion Date: 2020-11-15

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.

Conditions

Amyotrophic Lateral Sclerosis; Psychological Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Adaptation of "CALM"

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Anja Mehnert

Head of the Department of Medical Psychology and Medical Sociology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anja Mehnert-Theuerkauf, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Joseph Claßen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Locations

University Medical Center Leipzig

Leipzig, Saxony, Germany

Countries

Germany

Other Identifiers

ALS_Pilot

Identifier Type: -

Identifier Source: org_study_id