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Evaluation of the effectiveness of psychological interventions in chronic fatigue syndrome

Research into sleep disorders and chronic fatigue focuses on studies of insomnia, sleep-wake rhythm disorders in physical illnesses and chronic fatigue syndromes and the influence of various psychological therapy methods on the symptoms and quality of life of patients.

Target group

Women and men between the ages of 18 and 55 with chronic fatigue syndrome. No psychiatric inpatient treatment, psychiatric emergency treatment or suicide attempts in the last 3 months. Internet access and sufficient skills to use electronic devices. Have the willingness to engage in the applications of Acceptance Commitment Therapy (ACT) and the concept of mini-breaks in everyday life (MIA) or be able to wait for at least 3 months without therapy interventions.

Goal

This study will investigate the response to two non-drug therapies for chronic fatigue syndrome (CFS) in an observation period of 9 months, i.e. 13-14 weeks of group therapy and 2 follow-up appointments at 3 and 6 months after therapy. To this end, patients who have been diagnosed with CFS as part of an assessment by the Chronic Fatigue Consultation at the Clinic for Consultative Psychiatry and Psychosomatics, University Hospital Zurich, will be informed about the study. If the patient agrees to participate in the study, the participants are 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 teaches either the exercises from ACT or the MIA concept. The group therapy consists of 8 sessions, each lasting 90 minutes. At the first appointment, the possible causes and the pathogenesis of chronic fatigue syndrome are discussed, and in the subsequent sessions the exercises of one of the two therapy methods are taught. Participants in the group therapy are asked to continue the applications or techniques between sessions and to complete certain questionnaires during the sessions. In addition, blood and saliva samples are taken before and after therapy to determine inflammation levels and stress hormones and to analyze genetic components. Before and after the therapy, the activity and rest phases are measured by wearing a wristwatch for 7 days. After a waiting period of at least three months, the waiting participants are also admitted to one of the next therapy groups. A total of 76 participants will be included in the study over a period of three years to ensure that the results are meaningful.

Procedure: What can you expect as a participant?

If you decide to take part in the study, various data will be collected using questionnaires. After final assessment of your suitability for participation in the study, you will be randomly assigned to one of the three groups (two therapy groups and the waiting group) before the planned start of therapy. After detailed information about the clinical picture of chronic fatigue syndrome, you will be invited to group therapy at the Clinic for Consultative Psychiatry and Psychosomatics, USZ. On two or three dates (depending on group membership), a blood sample (quantity: 1 x 9 ml and 1x 2.5 ml, comparable to a ristretto) is taken by medically trained staff at the Clinic for Consultative Psychiatry and Psychosomatics, USZ. If you have been assigned directly to group therapy, these two appointments correspond to the appointment before the start of group therapy and the last group therapy appointment, if you have been assigned to the waiting group, an appointment before and after the waiting period of at least 3 months and after the group therapy has been completed. In addition, before each of these appointments you will be given or sent a wristband (similar to a wristwatch, waterproof and barely noticeable) with an integrated recording device that is worn on the wrist for 7 days and records arm movements. You will be asked to return the bracelet to the Clinic for Consultative Psychiatry and Psychosomatics, USZ after the recording. You will receive the tubes for collecting saliva from your mouth at the same time as the bracelet. The total amount of saliva to be removed is less than two teaspoons. The removal is effortless and painless and should be carried out on a working day without any unusual physical exertion on the same day. The saliva sample should be taken six times in one day and stored directly in the refrigerator (at 4° to 8°). All participants receive ACT or MIA interventions from an experienced doctor or psychotherapist after being assigned to a group therapy. You will be asked to complete various questionnaires at each appointment (i.e. six questionnaires at the first appointment, two at the second to sixth appointments and six at the last appointment). You will be asked to do the exercises (ACT or MIA) regularly at home between appointments. Three and six months after the last therapy session, you will also be asked to complete a questionnaire online, which will be sent to you by e-mail. If you have been allocated to the waiting group, you will be asked to complete six questionnaires at the appointment before and after the waiting period. In the intervening period, a questionnaire will be sent to you by e-mail at regular intervals (6 times in total) for you to complete. After waiting at least 3 months, you will also receive group therapy (ACT or MIA). The procedure after allocation to group therapy corresponds to that for direct allocation to group therapy. Assignment to ACT or MIA is random. Please note that your data will be registered if you contact the study management or study staff by telephone. If you are not interested in participating in the study, your data will be deleted immediately.