Fatigue, Long COVID Syndrome, Multicausal Fatigue, Post COVID Condition, Postviral Fatigue
Conditions
Keywords
neuroplastic therapy, group intervention
Brief 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.
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.
Interventions
BEHAVIORALMicro-choice-based intervention
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
Sponsors
University Hospital, Basel, Switzerland
Kämpf- Bötschi Stiftung
propatient Forschungsstiftung
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-center, open label, non-controlled proof-of-concept study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- Experiencing persistent fatigue with a significant impact on daily functioning (Chalder Fatigue- Scale bimodal ≥ 4)
Exclusion criteria
* 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: 1. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | up to 6 month | 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. |
| Fatigue | 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". |
| Somatic Symptom Severity | 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". |
| Somatic Distress | 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". |
| Depressive Symptoms | 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". |
| Anxiety Symptoms | 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". |
| Functional capacity | 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". |
| Change in Quality of life | 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"). |
| Work ability | up to 6 month | assessed via questionnaires: at full work, at partial work, not at work. |
| Work and Social Adjustment | 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. |
Countries
Switzerland
Contacts
CONTACTKatrin Bopp, Dr.
PRINCIPAL_INVESTIGATORKatrin Bopp, Dr.
University Hospital, Basel, Switzerland
Outcome results
None listed