University Hospital Basel
Basel, 4031, Switzerland
Location status: Recruiting
NCT Number: NCT07726082
This proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Basel, 4031, Switzerland
Location status: Recruiting
The intervention of this study includes a preparation phase, a four-day intensive group treatment, and a follow-up phase to support the integration of new behaviors into daily life. As no comparable program currently exists in Switzerland, this project addresses a significant gap in care. If found to be feasible, the intervention has the potential to improve quality of life, support reintegration into daily and professional activities, and reduce the risk of disability and long-term work incapacity, thereby also contributing to lower healthcare costs.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(-Need for a level of individual therapeutic support that exceeds what can be provided in a group setting; -Refusal to engage in group-based therapy; -Personality traits that are considered incompatible with group dynamics; -Failure to attend the mandatory preparatory webinar (no-show is considered a no-go); -Other significant reasons as determined by the therapeutic team)
The 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
Time frame: up to 6 month
defined as the percentage of participants who complete all phases of the study. To assess this, the investigators will evaluate:
Time frame: up to 6 month
Patient satisfaction will be assessed using the ZUF-8 ("Fragebogen zur Messung der Patientenzufriedenheit": the validated German version of Client Satisfaction Questionnaire). Satisfaction will be defined as a mean total score of ≥20, with no individual item scoring ≤2. This cut-off was selected based on prior research, in which scores ≥20 were interpreted as indicating "good" satisfaction.
Time frame: up to 6 month
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 month
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 month
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 month
The 8-item Patient Health Questionnaire Depression Scale (PHQ-8; 36) assesses the severity of depressive disorders. Patients are asked if in the past weeks, they were bothered by a problem, e.g. by having little interest or pleasure in doing things. Items are answered on a 4-point scale ranging from 0 = "not at all" to 3 = "nearly every day".
Time frame: up to 6 month
Anxiety is assessed with the Generalized Anxiety Disorder Questionnaire (GAD-7; 44). It assesses if the patient was bothered by complaints related to anxiety during the past 2 weeks, e.g. by asking about having trouble to relax. Items are answered on a 4-point Likert scale ranging from 0 = "not at all" to 3 = "nearly every day".
Time frame: up to 6 month
The World Health Organization Disability Assessment Schedule (WHODAS 2.0) assesses and classifies disability due to health problems during the past 4 weeks. This study will utilize the 12-item version. An example item would be "In the past 4 weeks, how much difficulty did you have in walking a long distance such as a kilometer (or equivalent)?". Items are answered on a 5-point scale ranging from 0 = "none" to 4 = "extreme or cannot do".
Time frame: up to 6 month
As a measure of life quality, the EuroHIS Quality-of-Life-8 (QOL-8; 42) will be used. This 8-item instrument assesses quality of life and perceived health during the past 4 weeks, e.g. by asking "Do you have enough energy for everyday life?". Items are answered on a 5-point scale, with wording differing between questions (e.g., from "very dissatisfied" to "very satisfied").
Time frame: up to 6 month
assessed via questionnaires: at full work, at partial work, not at work.
Time frame: up to 6 months
Work and Social Adjustment Scale (WSAS;(38) ) assesses functional impairment attributable to a health condition in key areas of daily life, including work, home management, social and private leisure activities, and close relationships. An example item is "Because of my illness, my ability to work is impaired." Items are rated on a 9-point scale ranging from 0 = "not at all impaired" to 8 = "very severely impaired". Higher total scores indicate greater functional impairment.
Contact information is provided by the study sponsor or research team.
University Hospital, Basel, Switzerland
Other
Micro-choice-based Intervention for Multicausal Fatigue: Proof of Concept Study
Acronym: CHOOSE-POC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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