Micro-choice-based Intervention for Multicausal Fatigue
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Hospital, Basel, Switzerland
About this trial
This proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Have insufficient proficiency in German to complete study-related questionnaires
Lack the cognitive capacity to understand study procedures (e.g. due to dementia)
Present with severe medical conditions that may interfere with participation (e.g., advanced organ failure, uncontrolled inflammatory or autoimmune diseases, or severe psychiatric disorders)
Have active cancer or are currently undergoing cancer treatment
Trial design
Design model
Single group
Treatments tested in this trial
Micro-choice-based intervention
BehavioralThe intervention consists of three phases: (1) a preparation phase including a preparatory webinar about the concept of micro-choices; active decision to participate; (2) a concentrated four-day group intervention based on the micro-choice model, delivered by an interdisciplinary team (psychosomatics, internal medicine, physiotherapy, occupational therapy); and (3) a follow-up phase over three weeks, during which participants are supported in integrating behavioral changes into everyday life through digital self-monitoring and an individual follow-up consultation
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Retention rate
defined as the percentage of participants who complete all phases of the study. To assess this, the investigators will evaluate: * Dropout rates at different phases of the study: preparation, concentrated intervention and follow up * Completion rates within each phase to identify potential barriers to adherence and engagement
Time frame
up to 6 monthSecondary outcomes
1
Patient satisfaction
Patient satisfaction will be assessed using the ZUF-8 (Fragebogen zur Messung der Patientenzufriedenheit), the validated German version of the Client Satisfaction Questionnaire (CSQ-8). Items are answered on a 4-point scale. Scores are summed across items once. Some items are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Time frame
up to 6 month2
Fatigue
Fatigue is assessed by the 11-item Chalder Fatigue Scale (46), e.g. by asking "Do you have difficulty concentrating?". Items are answered on a 4-point scale ranging from 0 = "Better than usual" to 3 = "much worse than usual".
Time frame
up to 6 month3
Somatic Symptom Severity
The Patient Health Questionnaire (PHQ-15; 34) assesses somatic symptom severity during the past 4 weeks. Patients are asked how impaired they felt by their symptoms, e.g. back pain. Items are answered on a 3-point scale ranging from 0 = "not bothered at all" to 2 = "bothered a lot".
Time frame
up to 6 month4
Somatic Distress
The Somatic Symptom Disorder Questionnaire (SSD-12; 35) assesses psychological features of somatic disorders, e.g. catastrophizing thoughts and health anxiety, e.g. with the statement "I think that my physical symptoms are signs of a serious illness". Items are answered on a 5-point scale ranging from 0 = "never" to 4 = "very often".
Time frame
up to 6 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Basel, Switzerland
Lead sponsor
Kämpf- Bötschi Stiftung
Collaborator
propatient Forschungsstiftung
Collaborator
Source ClinicalTrials.gov