Study of the Impact of the Use of Luminette on Seasonal Depressive Symptoms within a Radiotherapy Department

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1 Study of the Impact of the Use of Luminette on Seasonal Depressive Symptoms within a Radiotherapy Department Bragard, I. (1), Coucke, P. (1), Galétic, E. (2) and Poirrier, R. (2) (1) CHU de Liège (University Hospital), Radiotherapy Department, (2) CHU de Liège (University Hospital), Neurology Department Introduction In the general population, atypical depressive symptoms (need for sugar, prolonged sleep, weight gain and increased appetite, feeling of heaviness in the arms and legs, irritability) may occur in association with the dim light to which people are exposed in winter inside, or even outside in northern latitudes 1-4. An improper reset of the circadian clock by light is suggested as the cause of these symptoms 4. The consequences include a significant deterioration in social and occupational functioning 5.6. The most extreme form of this condition, Seasonal Affective Disorder (SAD) is described as a subtype of major or bipolar depressive disorder in DSM-IV 7. It is characterized by typical depressive symptoms (e.g. mood swings, loss of energy, and fatigue) and atypical ones (weight gain and hypersomnia) and by a distinct seasonal nature 8. The prevalence of SAD on life varies between 0 and 9.7% depending on the study, with a higher prevalence in the high northern latitudes 3.9. It is estimated to affect 5-6% of the population in our latitudes 10. There is also a subsyndromic form defined as a cluster of seasonal complaints not severe enough to fit the diagnosis of SAD 11, which affect an additional 8% of the population 12. In total, this disorder could therefore reach 14% of the population. Two systematic reviews of the literature have shown the effectiveness of light therapy in reducing seasonal and non-seasonal depressive symptoms 13,14. Two randomized controlled trials have shown that bright light therapy is superior to placebo control conditions 15,16. Another study 17 even showed an improvement in depressive symptoms using light therapy equivalent to the improvement obtained with an antidepressant (fluoxetine 20 mg/day). An illumination with an intensity of 10,000 lux (that is, the illumination unit per unit area) for half an hour in the morning seems to be sufficient 18. In normal subjects, although some studies have shown no improvement in mood or harmful effects of light therapy 22,23, Partonen and Lönnqvist 4 have shown that exposure to bright light in the winter is effective in improving the quality of life in terms of health and relieves distress in healthy subjects showing seasonal symptoms, as well as in those with no seasonal variations. The objective of this study is therefore twofold. On the one hand, to measure seasonal and non-seasonal depressive symptoms and the frequency of Seasonal Affective Disorder (SAD) and of the sub-syndrome (sub-sad) among caregivers in the radiotherapy department (with premises located in the basement) in autumn and winter. On the other hand, it is to analyze the effects of exposure to light through the use of Luminette (Lucimed, Belgium) on these seasonal and nonseasonal depressive symptoms. 1

2 Methodology Participants The study was proposed by mail to 89 members of staff (secretaries, nurses, psychologists, doctors) working in the radiotherapy department of the University of Liège over 4 sites (CHU de Liège, CHR de la Citadelle, CHC St. Joseph, CHAL Libramont). The inclusion criteria were as follows: must be working in the radiotherapy department at least part time and must be willing to participate in the entire study. The refusal to submit to assessments required by the study, as well as certain medical conditions (progressive eye disease, severe general medical condition, substance or alcohol abuse, psychosis, severe personality disorders requiring the attention of a specialist ) were the exclusion criteria. The volunteers were asked to complete a questionnaire about their health status, which determined whether they could participate. Thereafter, each one received an information form describing the course of the study, the operation of Luminette and its possible side effects, and an informed consent form that they were asked to sign. Anonymity was guaranteed. Design The study was of the ABAB crossover type: two 4-week periods of using Luminette (A) alternating with two 4-week periods without it (B). Five assessment periods were scheduled: the first one before the first period of using Luminette and the other ones at the end of each of the four 4-week periods. The study began on 15/10/2007 and ended on 08/03/2008. The total duration was therefore five months. Five assessment periods were alternated with four intervention periods: 1st assessment: 15/10/07 to 19/10/07; 1st intervention: 22/10/07 to 18/11/07; 2nd assessment: 19/11/07 to 23/11/07; 2nd intervention: 26/11/07 to 23/12/07; 3rd assessment: 24/12/07 to 28/12/07; 3rd intervention: 31/12/07 to 26/01/08; 4th assessment: 28/01/08 to 01/02/08; 4th intervention: 04/02/08 to 29/02/08; 5th assessment: 03/03/08 to 08/03/08. Light Therapy Luminette employs a technique of exposing the eyes to light free of ultraviolet and infrared radiation. The device uses a diffractive lens formed of a thin resin layer with a micro relief obtained through a holographic recording method. This lens, etched using a laser beam on a visor (attached in front of the glass), can focus the light emitted by a source placed outside the field of vision into the pupil of the eye. This diffractive lens can concentrate light beams toward the lower half of the retina, no matter the eye s angle of inclination. This system generates a uniform distribution of light on the eye without causing glare. A rechargeable battery, housed in a branch of the Luminette, provides autonomy for up to one hour. This is therefore a device which, like the sun, allows light to enter the eye in a natural way and reach the areas of the retina most favorable to treatment, while maintaining vision. According to the standard dosing regimen, the recommended exposure time for a session is half an hour for a light of 10,000 lux. During exposure times, participants can read, work on their computer, lunch or go about their usual routines. This technique allows an easy implementation within the workplace. 2

3 Participants had to use Luminette at work or at home in the morning between 7am and 9am, 30 minutes per day at least 5 days/week. They were asked to record each time and duration of treatment in a notebook. Assessment Procedures At the first assessment, participants completed a socio-demographic questionnaire. In addition, at each assessment, participants filled out four questionnaires: Structured Interview Guide for the Hamilton Depressive Rating Scale-seasonal affective disorders version (SIGH-HDRS). This seasonal depression scale establishes a diagnosis of SAD if the score is 20 or higher on the 17-item version, or if the score is 14 or higher on the 17-item version and the score on the 25-item version (the 17 items added to the 8 items typical of SAD) is 23 or higher. Seasonal Pattern Assessment Questionnaire (SPAQ) 24,25. This questionnaire specific to SAD gives two main scores 26. The Global Seasonality Score (GSS) provides a composite measure of change through the seasons of mood, social activities, appetite, sleep, weight and energy. Responses range from (0) no change to (4) very significant change. A second score indicates whether seasonal changes are considered a problem. Responses range from (0) not a problem to (5) debilitating problem. A diagnosis of SAD is established from a GSS of 11 with the scale s second score of at least 2 (moderate problem) 26. A diagnosis of sub-sad is established from a GSS of 11 with the scale s second score of 0 or 1, or from a GSS of 9 or 10 with the scale s second score of least Symptom Distress Checklist 90 (SCL-90) 27. This questionnaire is used to measure the profile of psychological symptoms. It includes 90 items that reflect nine dimensions: somatization, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. An extra dimension measures various other symptoms (e.g. sleep, appetite). A total score is also calculated. The higher the scores, the higher the severity of the symptoms. RAND 36-tems Health Survey (SF-36) 28. It measures overall health on 8 dimensions of functioning: physical functioning, role limitations caused by physical problems, pain, general health perceptions, vitality, social functioning, role limitations caused by emotional problems, general mental health and general physical health. It is sensitive to changes in the general population. The higher the scores, the better the health. Data Analysis Variance analyses were conducted to assess the impact of Luminette on the different symptoms measured using questionnaires from the five assessment periods. Analyses were performed using the SPSS 13.0 software. A qualitative analysis of the impact of treatment was also performed. 3

4 Results Participants Of the 89 members of the radiotherapy department, 33 volunteered for the study. One person had to be excluded because of a vision problem. Thirty-two people therefore agreed to participate in the first assessment phase (36% participation rate). Their average age was 38 years. Twenty-seven (84.4%) were women. The majority of participants were nurses (66%), worked fulltime (81.3%), and worked in a windowless office (84.4%). Five people consumed antidepressants and one consumed sleeping pills. The socio-demographic data are detailed in Table 1. Table 1. Socio-Demographic Data T1 (n=32) T2 (n=18) T3 (n=18) T4 (n=9) T5 (n=8) Age Num of ppl. % Num of ppl. % Num of ppl. % Num of ppl. % Num of ppl. % Average Standard Deviation Sex Female Male Sector Nurse Secretary Doctor Physician Work Schedule Part-time Full-time /4 time /5 time Office Windowless With Windows Medication* None Antidepressant Sleeping pill * The same person can consume multiple medications. Eight people participated in all assessment phases. No significant difference in scores at Time 1 to the various questionnaires (HDRS, SPAQ, SCL-90, SF-36) was observed between those who continued and those who discontinued. The causes of discontinuation of the use of the Luminette were of several types: negative side effects (e.g. headaches, nausea, insomnia, agitation, sore eyes), decreased interest in the study, hardware problems (e.g. battery problems, glasses too big), and change of schedule (change to part-time, holidays). Some side effects (such as nausea) disappeared when the person used Luminette while sitting down. Some positive effects were also reported: better sleep, less fatigue and afternoon drowsiness, improved mood, decreased sensation of nervousness, increased vitality and energy. 4

5 Impact of Luminette on Depressive Symptoms Table 2 below shows the mean scores and standard deviations for each questionnaire at each assessment period (T1 to T5). The 25-item version of the SIGH-HDRS, which takes into account seasonal symptoms, returned an average of 10.03, which corresponds to mild depression. As for the SPAQ, 5 participants (15.6%) met the two criteria for SAD and 5 (15.6%) other participants met the necessary criteria for sub-sad at Time 1. For the SCL-90, the highest average scores at Time 1 concerned sub-scales depression and various symptoms (e.g. sleep problems). For the SF36, the worst areas at Time 1 are the limitations of usual activities due to physical health problems and emotional problems. T1 (n=32) T2 (n=18) T3 (n=18) T4 (n=9) T5 (n=8) SIGH-HDRS µ Std. Dev. (σ) µ σ µ σ µ σ µ σ SPAQ 17-item version atypical items item version Global Seasonality Score (GSS) No. of people with SAD No. of people with sub-sad SCL-90 SF36 Somatization Obsessive symptoms Interpersonal sensitivity Depression Anxiety Hostility Phobias Paranoid features Psychotic features Various symptoms Total Physical functioning Physical problems Pain General health perceptions Vitality Social functioning Emotional problems General mental health General physical health The analysis of variance showed effects for five variables: SIGH-HDRS 17 items (F=3.163; p=.018), SIGH HDRS 8 atypical items (F=3.974; p=.005), SIGH HDRS 25 items (F=4.332; p=.003), SCL-90 obsessive symptoms (F=16.112; p=.000), SF36 vitality (F=2.768; p=.033). For each variable, post-hoc Tukey tests were conducted to determine at which time significant variations in symptoms took place. 5

6 For the SIGH-HDRS, there is a significant difference between Time 1 and Time 2 for the 17 items (p=.017), for atypical items (p=.002), and for the 25-item version (p=.002). Depressive symptoms decreased significantly after the first period of use of Luminette. Between Times 2 and 3 (without Luminette ), the scores do not increase significantly. Thus, there seems to be a stabilization of symptoms. Subsequently, effects are no longer significant. This lack of effect could be due to the significantly reduced sample. For SCL-90, the analysis of variance is significant for obsessive symptoms: there is a significant difference between Time 1 and every other assessment Time (p<.001), between Time 2 and Time 5 (p=.016), between Time 3 and Time 5 (p=.016). A significant decrease of these symptoms is observed overall. For SF36, the vitality variable shows a significant difference between Time 1 and Time 2 (p=.024). Vitality increases significantly after the first period of use of Luminette. Between Times 2 and 3 (without Luminette ), the scores do not decrease significantly. Thus, there seems to be a stabilization of vitality. Subsequently, effects are no longer significant. This lack of effect could be due to the significantly reduced sample. Some symptoms diminish with the use of Luminette in people diagnosed with SAD or sub-sad as well as in those without it. Qualitatively, it is interesting to note that of the 10 subjects who were diagnosed with SAD or sub-sad at Time 1, only 4 still preserved this diagnosis at Time 2 after using Luminette. At the end of the study, 10 people wanted to keep Luminette. Of these, 5 had been diagnosed with SAD or sub-sad at Time 1. Comparison Between Participants With SAD and Those Without It at Time 1 In Table 3, we see that people with SAD or sub-sad at Time 1 have significantly different scores from the other group for many symptoms. For SIGH-HDRS, they have the largest seasonal depressive symptoms. For SCL-90, obsessive symptoms, sensitivity to interpersonal depression, and various, as well as the total score, were significantly greater in the group with SAD or sub-sad. Finally, for SF36, they have poorer health: more significant pain and physical and emotional issues, and worse vitality, social functioning, and general mental health. At the socio-demographic level, there is no difference in age, gender, or sector between the 2 groups, or any influence from the work schedule or the presence of a window. Analyses of variance were conducted to study whether the decrease in depressive symptoms was significantly higher in the group with SAD or sub-sad (n=10) compared to the others (n=22) between Times 1 and 2. The results only showed one effect for SF36: the 'vitality' domain (F=8.16, p=.011) improved more in the group with SAD or sub-sad. 6

7 Table 3. Comparison Between Participants With SAD or a Sub-SAD and Those Without It at Time 1 Group 1 (n=22) Group 2 (n=10) T test SIGH-HDRS Average (µ) Std. Dev. (σ) µ σ Ttest p 17-item version atypical items item version SCL-90 SF36 Somatization Obsessive symptoms Interpersonal sensitivity Depression Anxiety Hostility Phobias Paranoid features Psychotic features Various symptoms Total (GSI) Physical functioning Physical problems Pain General health perceptions Vitality Social functioning Emotional problems General mental health General physical health Group 1: no SAD or sub-sad Group 2: SAD or sub-sad present 7

8 Discussion The study had two main objectives: first, to measure seasonal and non-seasonal depressive symptoms and the frequency of Seasonal Affective Disorder (SAD) and of the sub-syndrome (sub-sad) among staff in the radiotherapy department of the University Hospital CHU de Liège in autumn and winter; and secondly, to analyze the impact of Luminette (Lucimed, Belgium) on these symptoms. Of the 89 members of the radiotherapy department, 32 agreed to participate in the first assessment phase and only 8 were still present at the fifth assessment. The most common reasons for discontinuation were adverse side effects and a decrease in interest in the study. Regarding the first objective of the study, nearly a third of our sample (10 of 32) were diagnosed with SAD or sub-sad from the SPAQ. This percentage is high given the prevalence in the general population of up to 14% 10,12. We can make two hypotheses to explain this high percentage: first, it is possible that the radiotherapy department is an environment which particularly induces this type of disorder due to the lack of brightness on this floor, and secondly, it is likely that a selection bias of participants occurred initially because inclusion in the study was voluntary. In addition, symptoms of depression reported by SCL-90 as well as vitality and general physical health problems reported by SF36 were relatively high in our sample at Time 1. Regarding the second objective of this study, it appears that depressive symptoms measured by SIGH-HDRS decrease and vitality measured by SF36 increases significantly after the first period of use of Luminette. Between Times 2 and 3 (without Luminette ), the scores do not change significantly. Thus, there seems to be a stabilization of symptoms. Subsequently, effects are no longer significant. This lack of effect could be due to the decrease in the number of participants. These data are consistent with a previous study 4 which has already shown that repeated exposure to bright light in winter was effective to increase vitality and reduce depressive symptoms. As in our study, these improvements were observed in subjects with SAD as well as in subjects without SAD. Further analysis of the group of people with SAD or sub-sad was performed. This group had more pronounced depressive symptoms and poorer health compared to the others, without there being any socio-demographic difference. In addition, in this group, vitality was improved more than in other participants after using the Luminette between Time 1 and Time 2. Qualitatively, we also noticed that of the 10 people who wished to continue using the Luminette after the end of the study, 5 had a diagnosis of SAD or sub-sad at Time 1. Nevertheless, the results should be taken with caution taking into account certain limitations of this study: the sample size, the lack of the control group, and retrospective measurement tools. In conclusion, the systematic and repeated exposure to light through the use of Luminette in autumn and winter in a radiotherapy department seems effective in improving some aspects of quality of life related to health (vitality) and to decrease psychological distress (depressive symptoms). Future studies are required to replicate these encouraging results on larger samples. 8

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