Bright light therapy in rheumatoid arthritis to improve symptoms of fatigue and other disease outcomes: a randomized controlled pilot trial.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

I. Patient is on stable disease-modifying antirheumatic drug (DMARD) therapy for at least 3 months before the start of the study.
II. Disease Activity Scale (DAS) 28 <= 3.2.
III. Patient has abnormal feelings of fatigue as assessed by Checklist Individual Strength (CIS)-8 >= 27 (indicates abnormal levels of fatigue) (Bultmann et al., 2000).

Exclusion Criteria

I. Patient*s treatment consists of glucocorticoids, melatonin, or photosensitizing medication (e.g. amiodarone, benoxaprofen, chlorpromazine, demeclocycline, fleroxacin, nalidixic acid, ofloxacin, piroxicam, porfimer, psoralens, quinidine, and/or temoporfin (Anderson et al., 2016)) and/or changed in type or dose within the last 3 months before start of the study.
II. Patient*s medical conditions or recent medical events potentially compromises the effects of safety of light therapy (e.g. psychosis, mania, (probable) dementia, severe drug or alcohol abuse, delirium, severe acute suicidality, history of light-induced migraine or epilepsy or severe side effects to light therapy in the past, and/or pre-existing ocular abnormalities (e.g. glaucoma, retinitis, retinopathy, and/or macular degeneration)).
III. Midsleep on free days corrected for sleep deficit build up during working days (as measured with the Munich Chronotype Questionnaire) > 4:00h which reflected patients with a late chronotype.
IV. Patient has been involved in light therapy within 1 year before the start of the study.
V. Patient has been unable to maintain a regular sleep schedule (e.g. due to shift work) within 1 year before start of the study and/or expected during the study.
VI. Patient has travelled within three months before study start and/or has the plan to travel during the study to a time zone that deviates two or more hours from the Netherlands; and
VII. Patient or partner is pregnant or has a wish for pregnancy during the therapy period or gives breastfeeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is the difference between the intervention and control group<br /><br>in change from T0 to T1 in the primary study outcome fatigue (CIS-8 score).<br /><br>This difference will be reported as descriptive and will be preliminary<br /><br>statistically tested. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>In the same way will be explored: secondary therapy efficacy outcomes and<br /><br>circadian entrainment outcomes as well as follow-up effects (changes from T0 to<br /><br>T2). Also, the mediating role of circadian entrainment and depression on<br /><br>therapy efficacy will be explored. We also report the relevant parameter<br /><br>estimates and variances needed to design a possible future full-scale RCT<br /><br>(Feeley et al., 2009).</p><br>

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