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Psychological Therapy for Patients With ALS

NCT03975608 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-04-28

No results posted yet for this study

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

Interventions

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: 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.

Sponsors & Collaborators

  • University of Leipzig

    lead OTHER

Principal Investigators

  • Anja Mehnert-Theuerkauf, Prof. Dr. · University of Leipzig

  • Joseph Claßen, Prof. Dr. · University of Leipzig

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2020-10-31
Completion
2020-11-15

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03975608 on ClinicalTrials.gov