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Effectiveness of Acceptance Commitment Therapy or Micro Breaks in Patients With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis

Primary Purpose

Fatigue Syndrome, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Acceptance Commitment Therapy for chronic fatigue
Micro breaks in everyday life for chronic fatigue
Sponsored by
Sarah Schiebler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue Syndrome, Chronic

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • Possession of internet access
  • Sufficient skills to use electronic devices
  • The willingness to engage in the described therapeutic procedures or interventions (ACT, MBEL)

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University Hospital of ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Acceptance Commitment Therapy for chronic fatigue

Micro breaks in everyday life for chronic fatigue

Waiting Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 20, 2021
Last Updated
August 8, 2023
Sponsor
Sarah Schiebler
Collaborators
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05168124
Brief Title
Effectiveness of Acceptance Commitment Therapy or Micro Breaks in Patients With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis
Official Title
Study to Determine the Effectiveness of Therapy Methods (Acceptance Commitment Therapy, Micro Breaks) in Patients With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah Schiebler
Collaborators
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue Syndrome, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acceptance Commitment Therapy for chronic fatigue
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Micro breaks in everyday life for chronic fatigue
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Waiting Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Acceptance Commitment Therapy for chronic fatigue
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Micro breaks in everyday life for chronic fatigue
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue Severity Scale (FSS)
Description
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).
Time Frame
The entire duration of the study is 3 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Possession of internet access Sufficient skills to use electronic devices The willingness to engage in the described therapeutic procedures or interventions (ACT, MBEL) Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Schiebler, MD
Phone
0041 255 52 80
Email
sarah.schiebler@usz.ch
Facility Information:
Facility Name
University Hospital of Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Schiebler
Phone
0442555280
Email
sarah.schiebler@usz.ch

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Acceptance Commitment Therapy or Micro Breaks in Patients With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis

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