Background
Relevance
Aims of the study
Hypotheses on the primary objectives
Methods
Design
Setting
Ethical approval
The participants – inclusion and exclusion criteria
Screening for participation
The interventions
Individual cognitive behavioural therapy (CBT)
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During the intake phase (four sessions in 4 weeks), the cognitive behavioural therapist gets acquainted with the patient. The patient is asked about: the cause and course of the complaints, the present complaints, illness beliefs and illness behaviour, coping, social interactions/participation, and the expectations and personal goals of the patient. The therapist tries to determine the patient’s activity level by asking about activities during the day and week, and categorises the patient into a relatively active patient or a patient with a low activity pattern. The therapist explains the model of perpetuating cognitions and behaviour of CFS, and how to overcome CFS by changing patterns of thinking and changing behaviour.
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Graded exercise therapy (GET) is used to gradually increase physical activity. The patient follows a schedule to gradually increase activities at home (walking and bicycling). The schedule is provided by the therapist in accordance with the patient’s personal goals. The patient has to increase his/her activities at home and receives feedback afterwards during the next therapy session. If needed, schedules are made to increase social and/or mental activities as well. Another important subject during gradual reactivation is the balance between different activities and the patient’s personal responsibility to see to it.
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In the dialogues with the therapist and by doing exercises at home, the patient is taught to change negative beliefs regarding symptoms of fatigue, self-expectations and self-esteem. Specific lifestyle changes are encouraged if deemed appropriate.
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Sleep/wake rhythm: the patient is encouraged to change the sleep/wake rhythm immediately at the start of treatment into a regular sleep/wake rhythm. Sleeping during the day is not allowed.
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In accordance with the principles of GET, a plan to return to work will be made.
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If activities are increased and the sleep/wake rhythm is normalised, the patient is encouraged to unsettle him-/herself and to cope with these disturbances by applying the things he/she learned during therapy. Personal goals are evaluated and relapse prevention is addressed.
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The patient assigned to this group will attend 16 individual therapy sessions, spread out over 6 months with a psychologist or behavioural therapist. The first 6 weeks, the patient has weekly contact with the therapist, followed by once every 2 weeks for the next 20 weeks. The CBT protocol is fixed and different for relatively active patients and patients with a low activity pattern [37, 38]. In the treatment for the relatively active patient, the patient learns to spread out activities during the day and to vary different activities during the day. The patient learns to be active within physical and mental boundaries to overcome overburdening. With the use of cognitive therapy, cognitions and behaviour that may lead to overburdening (like not accepting boundaries in activity, and having high expectations) are the primary focus of treatment. After reaching the baseline (without peaks in complaints of the CFS) there will be a gradual increase of activities. For patients with a low activity pattern, activities will be increased from the beginning of therapy.
Individual multidisciplinary rehabilitation treatment (MRT)
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During a 2-week observation, therapists (psychologist, social worker, physical therapist and occupational therapist) get acquainted with the patient. During observation, they ask the patient about: the cause and course of the complaints, the present complaints, illness beliefs and illness behaviour, coping, the social environment the patient lives in, expectations and personal goals. The psychologist (two 1-h sessions) further elaborates on the psychological history, present psychological wellbeing, use of medical care including medication, stress factors, cognitions, attitudes and mood (state of mind). The social worker (two 1-h sessions) assesses the social context in which the patient lives (relationships, family and role in a family), work situation and communication. The physical therapist (five 30-min sessions) makes an estimation of the physical condition and the patient’s body awareness. The occupational therapist (four 30-min sessions) aims at ergonomics, lifestyle, day/week schedule and the variety of activities during the day/week. During observation, the treatable components are weighted in relation to the present complaints. If a strong relation exists between these components and the present complaints, these components will be addressed during treatment. In a team meeting, therapists and the rehabilitation physician discuss the components and methods that will be used during the treatment phase. The rehabilitation physician will discuss the conclusions of this meeting with the patient and ask for commitment to the proposed therapy. A treatment contract will be signed by the rehabilitation physician and the patient.
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Two weeks after ending the observation phase, the treatment phase starts. This phase takes 10 weeks to complete. Depending on the patient goals/needs and the relation between treatable components and present complaints, different methods will be more or less used in the treatment phase. The following methods can be incorporated:
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Body awareness therapy [39, 40]: aims to establish an increased awareness and consciousness of the body and its relation to psychological wellbeing. The patient learns to discriminate bodily symptoms other than fatigue and pain and learns to react on these healthy bodily symptoms. The patient will be coached by a physical therapist. Bodyscan, grounding, awareness exercises of the influence of thoughts and emotions on the body are some of the exercises that will be practised during treatment. In the end, the patient will be aware of the relation between the body, its physical function, psychological wellbeing and social interaction, and is able to react on stress in an appropriate way.
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Cognitive behavioural therapy: A psychotherapeutic approach in which elements of behavioural and cognitive therapy approaches are incorporated. CBT facilitates the identification of unhelpful, negative emotion-provoking thoughts, dysfunctional emotions, behaviours and cognitive patterns, and challenges them through a goal-oriented, systematic procedure. The patient learns to identify negative beliefs regarding the symptoms of fatigue, self-expectations or self-esteem, and is encouraged to challenge and change them into new, more realistic, more helpful alternatives.
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Gradual reactivation: At the start of treatment, activities are trained time contingent under close supervision of the physical therapist and occupational therapist. The patient follows schedules to gradually increase activities and receives immediate feedback during treatment when needed. The schedules of fitness exercises and swimming are provided by the physical therapist in accordance with the patient’s personal goals. Another schedule is provided by the occupational therapist in accordance with the patient’s personal goals to increase activity and vary activities at home. In the final phase of treatment, schedules are of less importance and the patient is encouraged to increase activities on his/her own without following a schedule (see pacing).
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Pacing: During the second phase of treatment, the patient is taught to pace his/her activities during the day/week. By developing awareness of healthy bodily symptoms the patient will be able to balance his/her activities (psychological as well as physical activities) before extreme fatigue or pain prevails. The schedule of time-contingent increase is no longer followed. The patient will pace his/her activities based on his/her own experiences.
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Principles of mindfulness. Mindfulness is a non-elaborative, non-judgemental, present-centred awareness in which each thought, feeling or sensation that arises is acknowledged and accepted as it is. The patient learns to self-regulate attention that is maintained on immediate experience, thereby allowing for increased recognition of mental events in the present moment. They also learn to observe the thoughts, emotions and sensations that arise, without making judgements about their truth, importance or value, and without trying to escape, avoid or change them. Regular practice of mindfulness skills increases self-awareness and self-acceptance, reduces reactivity to passing thoughts and emotions, and improves the ability to make adaptive choices [41]. In patients who have been chronically ill, mindfulness skills have a positive effect on depression, mood and activity level [42].
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Normalising of the sleep/wake rhythm. The sleep/wake rhythm will be discussed and with a schedule of 4 weeks will be gradually changed to the sleep/wake rhythm the patient desires. Sleeping during the day will be stopped immediately. If there are problems with the quality of sleep, principles of sleep hygiene are prescribed by the psychologist. Relaxation therapy is used to increase the efficiency of the resting moments during the day and to improve the quality of sleep during the night if needed.
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Social reintegration. Under supervision of the occupational therapist and social worker, the patient is coached to reintegrate into society by making a plan to return to his/her work or school, and to increase their social activities.
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Six weeks after ending the treatment phase, the patient will visit the social worker. Thirteen weeks after ending the treatment phase, the patient will visit two therapists of his/her choice who were involved in the previous treatment. Both after-care visits are used to stimulate and motivate the patient to practice at home what he/she has learned during the treatment phase.
CBT | MRT |
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Treatment focus on perpetuating factors | Treatment focus depending on the relation between the (precipitating, predisposing and perpetuating) factors and the presented complaints. |
Afterwards feedback at next therapy session | Immediately feedback during therapy |
Pays no attention to physical sensations | Stimulating awareness of healthy bodily symptoms |
CBT | CBT incorporated with principles of mindfulness |
Training the therapists to deliver the interventions
CBT
MRT
Recruitment of patients
Outcome measures
Primary outcome measures
Secondary outcome measures
Treatment expectancy and credibility
Mediation
Cost analysis
Assessment and procedures
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Checklist Individual Strength (CIS)
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Short Form 36 (SF-36)
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EuroQol- 5D (EQ-5D)
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Symptom Check List-90 (SCL-90)
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Self-Efficacy Scale-28 (SES 28)
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Causal Attribution List (CAL)
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Mindfulness Attention Awareness Scale (MAAS)
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Sickness Impact Profile-8 (SIP-8)
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Life Satisfaction Questionnaire, Dutch Version (LSQ-DV)