Fatigue Syndrome, ChronicNCT05168124
Effectiveness of Acceptance Commitment Therapy or Micro Breaks in Patients with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis
A study testing Acceptance Commitment Therapy for chronic fatigue and Micro breaks in everyday life for chronic fatigue in people with Fatigue Syndrome, Chronic, run by Sarah Schiebler at 1 site in Switzerland.
Trial summary
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a distinct disease entity with an estimated prevalence of 0.3-0.7% and more common in women (3:1 ratio). It can be diagnosed according to the Institute of Medicine (IOM) 2015 consensus definition using 3 major criteria and one of 2 minor criteria. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Fatigue Syndrome, Chronic
- What is being tested?
- Acceptance Commitment Therapy for chronic fatigue and Micro breaks in everyday life for chronic fatigue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Aug 2023to Jul 2026
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis for CFS/ME
- Psychiatric clinical stability in the past 3 months:
- No diagnostic change to other categories of the International Classification of Diseases (ICD-10)
- No psychiatric inpatient treatments
- No psychiatric emergency treatments
- No suicide attempts
Show all 9Show fewer
- Possession of internet access
- Sufficient skills to use electronic devices
- The willingness to engage in the described therapeutic procedures or interventions (ACT, MBEL)
Who cannot join
- Insufficient knowledge of German
- Severe psychiatric disorders (e.g. personality and posttraumatic stress disorders, dissociative and psychotic disorders, intelligence reduction, untreated attention deficit hyperactivity disorder) and acute suicidal tendencies
- Untreated or severe internal medicine disorders e.g., thyroid dysfunction, central and obstructive sleep apnea syndrome (i.e., apnea-hypopnea index >15 and/or "high-risk group for obstructive sleep apnea" according to the Berlin Questionnaire)
- Cardiovascular disease such as chronic heart failure
- Severe or untreated neurological diseases (e.g. Parkinson's disease, dementia, restless legs syndrome, narcolepsy)
- Alcohol and drug dependence
Show all 10Show fewer
- Initiation of psychopharmacotherapy at a dosage provided for guideline-appropriate treatment of a mental disorder according to the Drug Compendium in the past 3 months
- Start of other psychotherapy procedures in the last 3 months
- Other parallel therapy methods (e.g. acupuncture, qigong, osteopathy)
- Somatic (sleep-disrupting) treatments, cortisone treatment, or radio-/chemotherapy in the last 6 months
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 of Zurich
Zurich, 8091
Sarah Schiebler, 0442555280, sarah.schiebler@usz.ch
About this study
Official title: Study to Determine the Effectiveness of Therapy Methods (acceptance Commitment Therapy, Micro Breaks) in Patients with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a distinct disease entity with an estimated prevalence of 0.3-0.7% and more common in women (3:1 ratio). It can be diagnosed according to the Institute of Medicine (IOM) 2015 consensus definition using 3 major criteria and one of 2 minor criteria.
Diagnosis requires that the patient have the following three symptoms:
Read more
- A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest,
- Post-exertional malaise,* and
- Unrefreshing sleep*
At least one of the two following manifestations is also required:
- Cognitive impairment* or
- Orthostatic intolerance
Note* Frequency and severity of symptoms should be assessed. The diagnosis of ME/CFS should be questioned if patients do not have these symptoms at least half of the time with moderate, substantial, or severe intensity.
Currently, individually tailored therapy with emphasis on cognitive behavioral therapy and graduated activity therapy is considered the therapy of first choice, although their effectiveness has been critically questioned in recent years. There are often frustrating treatment courses, a larger proportion of partial remissions, a significantly smaller proportion of full remissions and return to work.
The study aims to evaluate patients of the outpatient service for chronic fatigue at the Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, Switzerland, in the context of a group therapy for the treatment of CFS/ME in respect to the response to different, non-drug based therapeutic procedures and to gain knowledge about the effects of the therapy.
The study is a clinical comparative study of therapeutic procedures/interventions without the use of drugs or a medical product. The interventions are Acceptance Commitment Therapy (ACT) and Micro Breaks in Everyday Life (MBEL) adapted to CFS/ME. The collection of biological samples (saliva, blood) and health-related personal data (actigraphy, psychometric data from questionnaires) is associated with minimal risks and burdens.
- Conditions
- Fatigue Syndrome, Chronic
- Being tested
- Acceptance Commitment Therapy for chronic fatigue, Micro breaks in everyday life for chronic fatigue
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance Commitment Therapy for chronic fatigueBehavioural
ACT was originally developed for the treatment of depression and anxiety. Recently, a single study investigated ACT as a therapeutic approach in CFS/ME and showed no negative effects on disease progression. ACT is characterized by acceptance- and mindfulness-based techniques, serves to promote acceptance and the development of new value goals, and can thereby open up new perspectives on life, which would be promising in terms of a reduction of symptom focus that seems to be a crucial effective factor for an improvement in exhaustion states. The intervention involves psychoeducation and teaching coping strategies for dealing with symptoms, most notably fatigue, postexertional malaise, unrestful sleep, cognitive decline, and orthostatic dysregulation. For this purpose, the therapy manual designed for anxiety disorders is adapted to the needs of patients with CFS, the exercises and worksheets that teach the acceptance- and mindfulness-based techniques are adapted to the symptoms.
Micro breaks in everyday life for chronic fatigueBehavioural
In terms of break design in the work context, research in recent years has increasingly focused on so-called "micro breaks" (MB) - mini breaks of one to five minutes in length. Transferred to mini breaks in everyday life (MBEL), there have been found fundamentally positive effects in terms of performance, vitality and well-being, which could also have a positive impact on the clinical picture of CFS/ME. However, practically no research results are yet available with regard to the implementation of MB in everyday life of patients with CFS/ME. The effects of MB, on the other hand, have been tested several times in everyday work settings and showed desirable effects on mood, attention, fatigue, vitality, performance, and well-being.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance Commitment Therapy for chronic fatigue | Active comparator | ACT for chronic fatigue involves psychoeducation on the clinical picture of CFS/ME and teaching coping strategies for dealing with symptoms, most notably fatigue, postexertional malaise, unrestful sleep, cognitive decline, and orthostatic dysregulation. For this purpose, the therapy manual designed for generalized anxiety disorders is adapted to the needs of patients with CFS, i.e., the exercises and worksheets that teach the acceptance- and mindfulness-based techniques are adapted to the symptoms (fatigue, powerlessness, unrestful sleep, among others). In addition, value goals and scopes of action are defined, in which the individual stress limits of each participant are identified and taken into account. In addition, it is recommended that the participants move within their respective energy limits under the regular evaluation of activity and rest phases using a diary, as well as regularly apply study-specific interventions between the appointments of group therapy. Receives: Behavioral: Acceptance Commitment Therapy for chronic fatigue |
| Micro breaks in everyday life for chronic fatigue | Active comparator | Micro breaks in everyday life (MBEL) includes restructuring the patients' daily routine in terms of how they organize their breaks. A therapy manual is developed for this purpose, which is divided into three phases. In the first phase, patients learn to allow or integrate regular MB of one to five minutes in their daily routine. Appropriate examples are used to show when and where MB can be incorporated and this is practiced at home over the first few weeks until a routine has been established. Patients are encouraged to keep a break diary. In the second phase, the MBs are filled in with content. MB can be designed differently, e.g., with physical activity of moderate or high intensity, with short breathing or relaxation exercises, with nutrition or even with doing nothing. In the third phase, an individual optimization of the design of breaks in everyday life follows and an expansion towards meaningful mental time-out, a combination of relaxation break and mental activation. Receives: Behavioral: Micro breaks in everyday life for chronic fatigue |
| Waiting Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale (FSS)
The FSS comprises 9 questions, by answering which the patient can assess his limitations due to fatigue of the past week on a 7-point scale. The FSS is considered a well-established assessment tool for surveying subjective fatigue, the resulting limitations in daily, social, as well as occupational life and physical activities. Total score 36-52 is indicative of moderate fatigue ("mild/ no fatigue" at FSS total ≤ 35, "moderate fatigue" at 36 ≤ FSS total ≤ 52), score greater than or equal to 53 is indicative of severe fatigue ("severe fatigue" at FSS total ≥ 53).
Measured: The entire duration of the study is 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start8 Aug 2023
- Primary completionDec 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue Syndrome, ChronicStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah Schiebler
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Sarah Schiebler, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168124
- Sponsor's protocol ID
- 2021-00671
- Status last verified
- Dec 2024
- First submitted
- 20 Nov 2021
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine the Effectiveness of Therapy Methods (acceptance Commitment Therapy, Micro Breaks) in Patients with Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis
- ClinicalTrials.gov ID
- NCT05168124
- Acronym / sponsor ID
- 2021-00671
- Conditions
- Fatigue Syndrome, Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sarah SchieblerUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 23 Dec 2021 (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.
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a distinct disease entity with an estimated prevalence of 0.3-0.7% and more common in women (3:1 ratio). It can be diagnosed according to the Institute of Medicine (IOM) 2015 consensus definition using 3 major criteria and one of 2 minor criteria.
Diagnosis requires that the patient have the following three symptoms:
- A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest,
- Post-exertional malaise,* and
- Unrefreshing sleep*
At least one of the two following manifestations is also required:
- Cognitive impairment* or
- Orthostatic intolerance
Note* Frequency and severity of symptoms should be assessed. The diagnosis of ME/CFS should be questioned if patients do not have these symptoms at least half of the time with moderate, substantial, or severe intensity.
Currently, individually tailored therapy with emphasis on cognitive behavioral therapy and graduated activity therapy is considered the therapy of first choice, although their effectiveness has been critically questioned in recent years. There are often frustrating treatment courses, a larger proportion of partial remissions, a significantly smaller proportion of full remissions and return to work.
The study aims to evaluate patients of the outpatient service for chronic fatigue at the Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, Switzerland, in the context of a group therapy for the treatment of CFS/ME in respect to the response to different, non-drug based therapeutic procedures and to gain knowledge about the effects of the therapy.
The study is a clinical comparative study of therapeutic procedures/interventions without the use of drugs or a medical product. The interventions are Acceptance Commitment Therapy (ACT) and Micro Breaks in Everyday Life (MBEL) adapted to CFS/ME. The collection of biological samples (saliva, blood) and health-related personal data (actigraphy, psychometric data from questionnaires) is associated with minimal risks and burdens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acceptance Commitment Therapy for chronic fatigue | Active comparator | Behavioral: Acceptance Commitment Therapy for chronic fatigueACT for chronic fatigue involves psychoeducation on the clinical picture of CFS/ME and teaching coping strategies for dealing with symptoms, most notably fatigue, postexertional malaise, unrestful sleep, cognitive decline, and orthostatic dysregulation. For this purpose, the therapy manual designed for generalized anxiety disorders is adapted to the needs of patients with CFS, i.e., the exercises and worksheets that teach the acceptance- and mindfulness-based techniques are adapted to the symptoms (fatigue, powerlessness, unrestful sleep, among others). In addition, value goals and scopes of action are defined, in which the individual stress limits of each participant are identified and taken into account. In addition, it is recommended that the participants move within their respective energy limits under the regular evaluation of activity and rest phases using a diary, as well as regularly apply study-specific interventions between the appointments of group therapy. |
| Micro breaks in everyday life for chronic fatigue | Active comparator | Behavioral: Micro breaks in everyday life for chronic fatigueMicro breaks in everyday life (MBEL) includes restructuring the patients' daily routine in terms of how they organize their breaks. A therapy manual is developed for this purpose, which is divided into three phases. In the first phase, patients learn to allow or integrate regular MB of one to five minutes in their daily routine. Appropriate examples are used to show when and where MB can be incorporated and this is practiced at home over the first few weeks until a routine has been established. Patients are encouraged to keep a break diary. In the second phase, the MBs are filled in with content. MB can be designed differently, e.g., with physical activity of moderate or high intensity, with short breathing or relaxation exercises, with nutrition or even with doing nothing. In the third phase, an individual optimization of the design of breaks in everyday life follows and an expansion towards meaningful mental time-out, a combination of relaxation break and mental activation. |
| Waiting Group | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Diagnosis for CFS/ME
- Psychiatric clinical stability in the past 3 months:
- No diagnostic change to other categories of the International Classification of Diseases (ICD-10)
- No psychiatric inpatient treatments
- No psychiatric emergency treatments
Key exclusion criteria (10 listed)
- Insufficient knowledge of German
- Severe psychiatric disorders (e.g. personality and posttraumatic stress disorders, dissociative and psychotic disorders, intelligence reduction, untreated attention deficit hyperactivity disorder) and acute suicidal tendencies
- Untreated or severe internal medicine disorders e.g., thyroid dysfunction, central and obstructive sleep apnea syndrome (i.e., apnea-hypopnea index >15 and/or "high-risk group for obstructive sleep apnea" according to the Berlin Questionnaire)
- Cardiovascular disease such as chronic heart failure
- Severe or untreated neurological diseases (e.g. Parkinson's disease, dementia, restless legs syndrome, narcolepsy)
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 |
|---|---|---|
| Acceptance Commitment Therapy for chronic fatigueACT was originally developed for the treatment of depression and anxiety. Recently, a single study investigated ACT as a therapeutic approach in CFS/ME and showed no negative effects on disease progression. ACT is characterized by acceptance- and mindfulness-based techniques, serves to promote acceptance and the development of new value goals, and can thereby open up new perspectives on life, which would be promising in terms of a reduction of symptom focus that seems to be a crucial effective factor for an improvement in exhaustion states. The intervention involves psychoeducation and teaching coping strategies for dealing with symptoms, most notably fatigue, postexertional malaise, unrestful sleep, cognitive decline, and orthostatic dysregulation. For this purpose, the therapy manual designed for anxiety disorders is adapted to the needs of patients with CFS, the exercises and worksheets that teach the acceptance- and mindfulness-based techniques are adapted to the symptoms. | Behavioural | Acceptance Commitment Therapy for chronic fatigue |
| Micro breaks in everyday life for chronic fatigueIn terms of break design in the work context, research in recent years has increasingly focused on so-called "micro breaks" (MB) - mini breaks of one to five minutes in length. Transferred to mini breaks in everyday life (MBEL), there have been found fundamentally positive effects in terms of performance, vitality and well-being, which could also have a positive impact on the clinical picture of CFS/ME. However, practically no research results are yet available with regard to the implementation of MB in everyday life of patients with CFS/ME. The effects of MB, on the other hand, have been tested several times in everyday work settings and showed desirable effects on mood, attention, fatigue, vitality, performance, and well-being. | Behavioural | Micro breaks in everyday life for chronic fatigue |
Primary outcome
Fatigue Severity Scale (FSS)
Time frame: The entire duration of the study is 3 years.
The FSS comprises 9 questions, by answering which the patient can assess his limitations due to fatigue of the past week on a 7-point scale. The FSS is considered a well-established assessment tool for surveying subjective fatigue, the resulting limitations in daily, social, as well as occupational life and physical activities. Total score 36-52 is indicative of moderate fatigue ("mild/ no fatigue" at FSS total ≤ 35, "moderate fatigue" at 36 ≤ FSS total ≤ 52), score greater than or equal to 53 is indicative of severe fatigue ("severe fatigue" at FSS total ≥ 53).
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 16 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance Commitment Therapy for chronic fatigue and Micro breaks in everyday life for chronic fatigue in people with Fatigue Syndrome, Chronic, run by Sarah Schiebler 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 9 inclusion and 10 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 16 Dec 2024. 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 Sarah Schiebler, MBA, MD (0041 44 255 52 80, sarah.schiebler@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (FSS) (time frame: The entire duration of the study is 3 years.). 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 16 Dec 2024.