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Does CBT Improve the Effect of Light Therapy in Delayed Sleep Phase Syndrome Compared to Only Light Therapy - Short and Long Term Follow up
Sponsor study identifier
interventional
57
1 country
1
Study Start
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)Delayed sleep phase syndrome (DSPS) is the most common of the circadian rhythm sleep disorders (CRSD). A person with DSPS have sufficient sleep quality, but their circadian clock is delayed compared to the normal 24-h period. They fall asleep around 03.00-04.00 at night and sleeps until 02.00-03.00 in the afternoon. This syndrome is most frequent among young people between 16-25 years, which conveys that school attendance and education are affected, and also often results in severe social consequences. DSPS is sometimes associated with depression and personality disorders and may aggravate psychiatric symptoms. This syndrome is highly underdiagnosed and there are no detailed guidelines how to treat it. The treatment usually consists of light therapy, chronotherapy or melatonin. There is a lack of guidelines how often, with which wavelength, and how long the treatment of DSPS patients shall go on. Previous studies shows that light therapy often is effective. The effect gets even better if melatonin is administered concurrently. However, the frequency of relapse is high. Thus, DSPS is a prevalent syndrome in young adults with severe consequences on normal daytime functioning. There are almost no treatment options available in health care settings. There is a clear need for further studies on this topic. The main purpose of the present study is to evaluate the clinical effects of short and long-term treatment by using light therapy and cognitive behaviour therapy (CBT). CBT is recommended at mild to moderate depression and anxiety. It also has some evidence in treating insomnia. Patients with DSPS often have al of these symptoms and therefore the investigators would like to investigate if CBT can enhance the effect of light therapy. Firstly, the investigators want to evaluate the short-term effects of light therapy with and without CBT. Secondly, the investigators want to evaluate if the patients who get CBT maintain a "normal" sleep rhythm and prevent relapse of DSPS compared to just light therapy for two weeks. The investigators also want to evaluate how this patient-group differs when it comes to behavioral factors compared to a matched reference group.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 26, 2011
Actual (reported)August 2011
Date type not reportedThis date has not been verified as actual or estimated.
August 18, 2011
Actual (reported)April 2013
Actual (reported)April 2013
Actual (reported)Change from baseline in sleep-diary at 6 months.
That the patients will go to bed before 01:00 and wake up not later than 09:00 a.m. or earlier.
Change from baseline in sleep-diary at 6 months.
Changes from baseline in sleep-diary at 6 weeks.
Changes from baseline in sleep diary at 6 weeks.
Change from baseline in Hospital anxiety-depression scale at 2 weeks
Change from baseline in Hospital anxiety-depression scale at 2 weeks
Change from baseline in Hospital anxiety-depression scale at 6 weeks
Change from baseline in Hospital anxiety-depression scale at 6 weeks
Change from baseline in Hospital anxiety-depression scale at 6 months
Change from baseline in Hospital anxiety-depression scale at 6 months
Change from baseline in Insomnia Severity Scale at 2 weeks
Change from baseline in Insomnia Severity Scale at 2 weeks
Does DLMO correlate with sleep diary
baseline
Is DLMO important for setting the time to start light therapy
From baseline to 2 weeks
Is scores in MEQ important to decide when to start light therapy in the morning.
from baseline to 2 weeks of Light therapy
Two weeks of light therapy and after that 4 weeks of Cognitive behaviour therapy (CBT)
Light therapy every morning during 30 minutes for two weeks. CBT for 90 to 120 minutes weekly during four weeks.
Light therapy every morning during 30-45 minutes for two weeks.
Sleep department
Uppsala, 75185, Sweden
Benloucif S, Burgess HJ, Klerman EB, Lewy AJ, Middleton B, Murphy PJ, Parry BL, Revell VL. Measuring melatonin in humans. J Clin Sleep Med. 2008 Feb 15;4(1):66-9.
Gooley JJ. Treatment of circadian rhythm sleep disorders with light. Ann Acad Med Singap. 2008 Aug;37(8):669-76.
Bjorvatn B, Pallesen S. A practical approach to circadian rhythm sleep disorders. Sleep Med Rev. 2009 Feb;13(1):47-60. doi: 10.1016/j.smrv.2008.04.009. Epub 2008 Oct 8.
Katarina ML Danielsson, M.D.
Sleep department, Uppsala University Hospital, Sweden
Agneta Markstroem, Ass. Prof.
Sleep department, Uppsala University Hospital, Sweden
Jan-Erik Broman, Ass. Prof.
Sleep department, Uppsala University Hospital, Sweden
Markus Jansson-Fröjmark, Ass. Prof.
Department of Psychology, Stockholm University, Sweden
57 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2011
First Posted
August 18, 2011
Study Start
August 2011
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Dagan Y, Yovel I, Hallis D, Eisenstein M, Raichik I. Evaluating the role of melatonin in the long-term treatment of delayed sleep phase syndrome (DSPS). Chronobiol Int. 1998 Mar;15(2):181-90. doi: 10.3109/07420529808998682.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
April 25, 2013
Record last verified: 2013-04
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Source: ClinicalTrials.gov.
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