The aim of the study is to examine in 144 patients with primary Sjögren*s syndrome, non-Sjögren sicca syndrome, rheumatoid arthritis and systemic lupus erythematosus, whether a intervention consisting of cognitive-behavioural therapy combined with…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fatigue
Secondary outcome
Physical functioning, mental wellbeing, subjective and objective dryness of the
eyes and mouth, physical activity, sleep,
Background summary
Invalidating fatigue is a prevalent and debilitating symptom of syndromes in
which key symptoms are dryness of the eyes (keratoconjunctivitis sicca) and
mouth (xerostomia). Examples are Sjögren's syndrome and non-Sjögren*s sicca
syndrome, but also rheumatic diseases such as rheumatoid arthritis and systemic
lupus erythematosus. Although fatigue is indisputably an adverse consequence of
the diseases, to target fatigue cognitive-behavioural therapy combined with
exercise training is most promising. In other diseases and syndromes, this
combined therapy has been shown successful, but such interventions have as yet
not been evaluated in rheumatic diseases. In this study, a psychological
intervention aimed at the reduction of fatigue will be tested.
Study objective
The aim of the study is to examine in 144 patients with primary Sjögren*s
syndrome, non-Sjögren sicca syndrome, rheumatoid arthritis and systemic lupus
erythematosus, whether a intervention consisting of cognitive-behavioural
therapy combined with exercise training will improve fatigue. Three groups of
48 patients each (primary Sjögren's syndrome, non-Sjögren sicca syndrome,
rheumatoid arthritis and systemic lupus erythematosus) will participate: a
treatment group, a waiting-list control group, and a non-treatment group. We
expect that the intervention will improve fatigue.
Study design
An open randomised controlled trial with three repeated (pre- and post
intervention and six months follow-up) assessments in a treatment group and a
waiting-list control group matched on age and gender. For comparison purposes,
all assessments will also be taken in a non-treatment group with no intention
to treat, but otherwise similar to the groups with an intention to treat, to
examine differences in the course of fatigue, disease activity and
psychological factors.
Intervention
Patients in the treatment group receive a structured outpatient treatment
program in a group setting of 6-8 participants. Treatment consists of 16
twice-weekly sessions and one booster session three months after treatment
completion, with every regular session starting with two hours of cognitive
behavioral therapy, followed by two hours of exercise training. The patient*s
partner (or other significant relation) will be invited by the patient to
attend the third, ninth and fifteenth session. The treatment focuses on
diminishing the daily perceived cognitive, behavioral, emotional and social
consequences of fatigue and accompanying symptoms. Every session, guided by a
cognitive behavioral therapist, starts with discussion of the assignments that
were trained at home, then the specific topic of the session will be introduced
and practiced with the other participants, and finally the homework for the
next session will be explained. The cognitive behavioral therapy will focus on
realistic goal setting, a balanced daily activity program, cognitive
restructuring techniques, and assertive social skills. The exercise training,
led by physiotherapists, aims to increase the level of physical fitness and
flexibility. Each exercise session consists of relaxation training, aerobic
exercises (e.g., cycling, gymnastic exercises), and hydrotherapy or anaerobic
exercises (e.g., strength and flexibility exercises, functional walking
training). During the exercise training, patients learn to gradually and
systematically increase their daily exercises.
Study burden and risks
The study will not involve risks for the participants, but a significant time
investment is asked from the participants, who will come twice a week to the
therapeutic center for an intervention of 4 hours each. During the blood
examination at baseline, there is a slight risk of excessive bleeding, fainting
or feeling light-headed, hematoma, or an infection. The completion of
questionnaires at three time points is a small burden. A benefit of
participation is the possible reduction of fatigue and improvement of quality
of life (wellbeing and functioning).
Heidelberglaan 1
Utrecht 3584 CS
NL
Heidelberglaan 1
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
- Patients >= 18 years. Patients with Sjögren's syndrome fulfill the European criteria for classification (Vitali et al., 2002). Patients in whom no other cause for dryness was found and who did not fulfill the European classification criteria of Sjögren syndrome, are classified as non-Sjögren's sicca syndrome. Patients with rheumatoid arthritis fulfill ACR criteria (Amett et al., 1988). Patients with systemic lupus erythematosus fulfill the ACR criteria (Tan et al., 1982).
- A score >= 14 on the Multidimensional Fatigue Inventory (MFI) in a previous questionnaire study (ID = NL24985.041.08);
- No medication or stable use of regular medication during the intervention;
- Motivated to participate in a cognitive-behavioural therapy combined with exercise training.
Exclusion criteria
- Participation in other (recent) interventions which can possible effect fatigue (i.e. start of using anti-depressants during the last half year, or participating in a pharmacological trial);
- Pregnancy or wish to become pregnant the upcoming year;
- Physical inability to participate in the intervention;
- Severe psychopathology;
- Illiteracy or difficulty to communicate in Dutch.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34073.041.10 |