Study on the assessment of the effectiveness of therapeutic procedures (Acceptance and Commitment Therapy (ACT), Mini-breaks in daily life (MIA)) in patients with chronic fatigue syndrome

Summary description of the study

This study will examine the response to two non-pharmacological therapeutic procedures in chronic fatigue syndrome (CFS) over an observation period of 9 months, i.e., 13-14 weeks within the framework of group therapy and 2 follow-up appointments after 3 and 6 months post-therapy. For this purpose, patients who were diagnosed with CFS during the assessment in the chronic fatigue consultation at the Consultative Psychiatry and Psychosomatics Clinic, University Hospital Zurich, will be informed about the study. With the consent of the patient to participate in the study, participants will be randomly assigned to one of the groups, i.e., to one of the two therapy groups or to a waiting group. In group therapy, a psychotherapist will either teach the exercises from Acceptance and Commitment Therapy (ACT) or the concept of Mini-breaks in daily life (MIA). The group therapy consists of 8 sessions, each lasting 90 minutes. In the first session, the possible causes and the onset of chronic fatigue syndrome will be discussed, and in the following sessions, the exercises of one of the two therapeutic procedures will be taught. Participants in group therapy will be asked to continue the applications or techniques between sessions and to fill out certain questionnaires during the sessions. Additionally, before and after therapy, blood and saliva samples will be taken to determine inflammatory values and stress hormones, as well as to analyze genetic components. A measurement of activity and rest phases will be conducted before and after therapy by wearing a wristwatch for 7 days. Waiting participants will also be included in one of the next therapy groups after a waiting period of at least three months. For good significance, a total of 90 participating individuals will be included in the study over three years.

(BASEC)

Intervention under investigation

Acceptance and Commitment Therapy is a well-established therapeutic procedure and effective in treating anxiety and obsessive disorders as well as depressive disorders. ACT includes education about the clinical picture of CFS/ME and the transmission of coping strategies for dealing with symptoms, primarily fatigue, the regular occurrence of malaise after physical and mental exertion, unrefreshing sleep, cognitive deficits, and/or dizziness. Within the framework of group therapy, mindfulness-based exercises are conducted according to a therapeutic manual tailored to the needs of patients with CFS/ME, and worksheets are used to promote acceptance of symptoms and the development of life and value goals. Additionally, areas of action are defined in which the participant establishes their individual load limits and considers them in planning their daily life. Mini-breaks in daily life MIA include, in addition to education about the clinical picture of CFS/ME, a restructuring in the daily life of patients regarding their break management. For this purpose, a therapeutic manual is developed, which is divided into three phases. In the first phase, patients learn to allow or integrate regular mini-breaks of one to five minutes into their daily routine. With appropriate examples, it will be shown when and where a mini-break can be incorporated, and this will be practiced at home over the first weeks until a routine is established. Patients are encouraged to keep a break diary. In the second phase, the mini-breaks are filled with content. Using examples, it is shown that mini-breaks can be structured 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 break management in daily life follows, and an extension towards a meaningful mental break, a combination of relaxation break and mental activation. There are currently no studies on the implementation of mini-breaks in daily life. However, the effects of mini-breaks or mindfulness-based breaks have been repeatedly examined in the professional context and have shown desired effects, including on mood, attention, fatigue, vitality, performance, and well-being.

(BASEC)

Disease under investigation

Chronic fatigue syndrome / myalgic encephalomyelitis is a relatively common condition characterized by a substantial impairment in the ability to perform daily, social, occupational, and private activities under a newly arisen, severe fatigue that lasts at least 6 months and is not alleviated by rest or is not the result of excessive exertion. Additionally, regular malaise after physical and mental exertion and unrefreshing sleep occur on most days of the week. Among the symptoms, one of the following may occur, such as recurrent dizziness upon position changes as an indication of orthostatic intolerance or concentration and memory disturbances.

(BASEC)

Sponsor

Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital of Zurich, Switzerland

(BASEC)

Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee Zurich

(BASEC)

Date of authorisation

09.11.2021

(BASEC)

Results of the trial