Multicausal FatigueCHOOSE-POCNCT07726082
Micro-choice-based Intervention for Multicausal Fatigue
A study testing Micro-choice-based intervention in people with Multicausal Fatigue and Fatigue, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multicausal Fatigue, Fatigue, Post COVID Condition
- What is being tested?
- Micro-choice-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Aug 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experiencing persistent fatigue with a significant impact on daily functioning (Chalder Fatigue- Scale bimodal ≥ 4)
Who cannot join
- 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
- Are deemed incompatible with group participation during the preparation phase, based on a team assessment. Reasons for exclusion based on group incompatibility include:
- Need for a level of individual therapeutic support that exceeds what can be provided in a group setting; b) Refusal to engage in group-based therapy; c) Personality traits that are considered incompatible with group dynamics; d) Failure to attend the mandatory preparatory webinar (no-show is considered a no-go); e) Other significant reasons as determined by the therapeutic team)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Katrin Bopp, Dr., +41 61 265 50 05, katrin.bopp@usb.ch
Katrin Bopp, Dr.
About this study
Official title: Micro-choice-based Intervention for Multicausal Fatigue: Proof of Concept Study
This proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.
Read the detailed description
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.
- Conditions
- Multicausal Fatigue, Fatigue, Post COVID Condition, Long COVID Syndrome, Postviral Fatigue
- Being tested
- Micro-choice-based intervention
- Keywords
- neuroplastic therapy, group intervention
- Medical subject headings
- Fatigue, Post-Acute COVID-19 Syndrome, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-choice-based interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Not described Receives: Behavioral: Micro-choice-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 month
Secondary outcomes (10)
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.
Measured: up to 6 month
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".
Measured: up to 6 month
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".
Measured: up to 6 month
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".
Measured: up to 6 month
Depressive Symptoms
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".
Measured: up to 6 month
Anxiety Symptoms
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".
Measured: up to 6 month
Functional capacity
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".
Measured: up to 6 month
Change in Quality of life
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").
Measured: up to 6 month
Work ability
assessed via questionnaires: at full work, at partial work, not at work.
Measured: up to 6 month
Work and Social Adjustment
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start13 Aug 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multicausal FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, open label, non-controlled proof-of-concept study
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Kämpf- Bötschi Stiftung, propatient Forschungsstiftung
- Responsible party
- Sponsor
- Investigators
- Katrin Bopp, Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726082
- Sponsor's protocol ID
- 2025-01861; th25meinlschmidt2
- Other IDs
- 2025
- Acronym
- CHOOSE-POC
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-choice-based Intervention for Multicausal Fatigue: Proof of Concept Study
- ClinicalTrials.gov ID
- NCT07726082
- Acronym / sponsor ID
- CHOOSE-POC / 2025-01861; th25meinlschmidt2
- Conditions
- Multicausal Fatigue, Fatigue, Post COVID Condition, Long COVID Syndrome, Postviral Fatigue
- Keywords
- neuroplastic therapy, group intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Kämpf- Bötschi Stiftung, propatient Forschungsstiftung
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, open label, non-controlled proof-of-concept study
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Micro-choice-based intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Experiencing persistent fatigue with a significant impact on daily functioning (Chalder Fatigue- Scale bimodal ≥ 4)
Key exclusion criteria (6 listed)
- 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
- Are deemed incompatible with group participation during the preparation phase, based on a team assessment. Reasons for exclusion based on group incompatibility include:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-choice-based interventionThe 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 | Behavioural | Intervention Arm |
Primary outcome
Retention rate
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: * 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
10 secondary outcomes
Patient satisfaction
Time frame: up to 6 month
Fatigue
Time frame: up to 6 month
Somatic Symptom Severity
Time frame: up to 6 month
Somatic Distress
Time frame: up to 6 month
Depressive Symptoms
Time frame: up to 6 month
Anxiety Symptoms
Time frame: up to 6 month
Functional capacity
Time frame: up to 6 month
Change in Quality of life
Time frame: up to 6 month
Work ability
Time frame: up to 6 month
Work and Social Adjustment
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katrin Bopp, Dr. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-choice-based intervention in people with Multicausal Fatigue and Fatigue, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katrin Bopp, Dr. (+41 61 265 50 05, katrin.bopp@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate (time frame: up to 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.