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monochromatic blue light vs standard light treatment in seasonal complaints


- candidate number15878
- NTR NumberNTR4342
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-dec-2013
- Secondary IDsNL33067.042.10 CCMO
- Public Titlemonochromatic blue light vs standard light treatment in seasonal complaints
- Scientific TitleRandomized and controlled study of the effects of low intensity monochromatic 'blue light' compared to the standard light treatment of seasonal complaints (winter depression and winterblues)
- ACRONYM
- hypothesisSeasonal affective disorder, wintertype, according to DSM-IV is depreesion with a seasonal pattern in wich the complaints exist in fall/winter and remission tooks place in spring/summer at an almost yearly basis.Epidemiological research in the Netherlands shows that 3% of the adults suffer from SAD and 8% from winterblues..

It has been shown that light treatment is effective, but the etiology of SAD and the working mechanism of light treatment are still unknown. One of the hypotheses is the phase shift hypothesis, which postulated that some biological processes are shifted compared to the 24 h rhythm of the environment. Exposure to bright light can cause a phase shift. If the biological clock is running in phase, SAD complaint can improve..

Recently novel photoreceptors in the eye are discovered. They have no influence on the visual system, but are sensitive for light, especially for light with a short wavelength (blue light). If blue light with a low intensity can have the same effect s compared to standard light therapu with a high intensity, than it is possible to ssimplify the traetment an to incorperate it in the life style of the
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria- age between 18-65 yr
- no other treatments for seasonal complaints during the same time
- no traveling to southern counties during study period
- no use of tanning fixtures during study period
- informed consent

1. seasonal affective disorder (SAD), winter type, according to DSM-IV score of at least 18 on the first 24 items of the SIGH-SAD
2. sub-syndromal seasonal affective disorder (sub-SAD, winterblues) acording to the Kasper et al. (1988) criteria:
- SPAQ-GSS score of 8,9 or 10 and at least light seasonal complaints or
- SPAQ-GSS score of 11 score of 12-17 on the first 24 items of the SIGH-SAD
- Exclusion criteriaother Axis -I disorders according to DSM-IV acute suicidal risk use of pschopharmaca or photosensitsizing drugs eye diseases or complaints exept aging diabetes epilepsy night shifts
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2010
- planned closingdate30-apr-2011
- Target number of participants100
- Interventions1. Patients with Seasonal Affective Disorder, age 18yr. or older
A comparison of the effects of exposure to monochromatic light (blue light) vs standard light treatment 5 consecutive days from 8.00-8.30 a.m. in the clinic, at day 4, 5, 6, 7, 8 of the 15 days study design
2. Subjects with sub-syndromal Seasonal Affective Disorder (winter blues), age 18 yr. or older
A comparison of the effects of exposure to monochromatic light (blue light) vs standard light treatment 5 consecutive days from 8.00-8.20 a.m. or earlier after awakening at home, at day 4, 5, 6, 7, 8 off the 15 days study design
- Primary outcomeSores on the SIGH-SAD interviews
- Secondary outcomeN/A
- TimepointsIn a 15 days study design, assessments by means of a standardized structured interviews (SIG-SAD) at iselection/inclusion and at day 1, 8 and 15 (primary outcome)
Daily self ratings (KSS; GSQS; AMS; AD-ACL)
Self ratings at inclusion (expectation, SPAQ and MEQ) and at day 15 (evaluation)
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMsc. W.B. Duijzer
- CONTACT for SCIENTIFIC QUERIESPhd. Y. Meesters
- Sponsor/Initiator Philips NV
- Funding
(Source(s) of Monetary or Material Support)
Philips
- PublicationsN/A
- Brief summaryBackground of the study:
Seasonal affective disorder, wintertype, according to DSM-IV is depreesion with a seasonal pattern in wich the complaints exist in fall/winter and remission tooks place in spring/summer at an almost yearly basis.Epidemiological research in the Netherlands shows that 3% of the adults suffer from SAD and 8% from winterblues..

It has been shown that light treatment is effective, but the etiology of SAD and the working mechanism of light treatment are still unknown. One of the hypotheses is the phase shift hypothesis, which postulated that some biological processes are shifted compared to the 24 h rhythm of the environment. Exposure to bright light can cause a phase shift. If the biological clock is running in phase, SAD complaint can improve..

Recently novel photoreceptors in the eye are discovered. They have no influence on the visual system, but are sensitive for light, especially for light with a short wavelength (blue light). If blue light with a low intensity can have the same effect s compared to standard light therapu with a high intensity, than it is possible to ssimplify the traetment an to incorperate it in the life style of the

Objective of the study:
To investigate the effects of exposure to low intensity monochromatic blue light compared to the effects of standard light trherapy in the treatment of SAD and winterblues

Study design:
A treatment stud in which in the experimental condition teh effects of exposure of low inetnsity blue monochromatic light is compared to the effects of exposure tot standard light treatment in the treatment of SAD and winterblues

Study population:
Patiens suffering from SAD are recruted from the SAD outpatient clinic of the UMCG. Participant suffering from winterblues are recruted by means of advertisements in local newspapers

Intervention (if applicable):
Experimental treatment is exposure to low intensity blue monochromatic light, compared to standard light treatment

Primary study parameters/outcome of the study:
Sores on the SIGH-SAD interviews
- Main changes (audit trail)
- RECORD20-dec-2013 - 2-feb-2014


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