Does Cognitive Behaviour Therapy (CBT) Improve the Effect of Light Therapy

NCT01419938 | Completed

• 1 other identifier: 2011/167
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delayed Sleep Phase Syndrome

Keywords

Light therapy; circadian rhythm; CBT

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (16)

• 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

Other Outcomes (3)

• 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

Study Arms (2)

Light therapy for two weeks

ACTIVE COMPARATOR

Device: Light therapy

Light therapy and CBT

ACTIVE COMPARATOR

Two weeks of light therapy and after that 4 weeks of Cognitive behaviour therapy (CBT)

Device: Light therapy and Cognitive behaviour therapy

Interventions

Light therapy and Cognitive behaviour therapy DEVICE

Light therapy every morning during 30 minutes for two weeks. CBT for 90 to 120 minutes weekly during four weeks.

Light therapy and CBT

Light therapy DEVICE

Light therapy every morning during 30-45 minutes for two weeks.

Light therapy for two weeks

Eligibility Criteria

• Age: 16 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of delayed sleep phase syndrome.

You may not qualify if:

• Eye diseases
• Active psychiatric disorder.
• Ongoing somatic disorder.

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala County Council, Sweden: collaborator

Study Sites (1)

Sleep department

Uppsala, 75185, Sweden

Location

Related Publications (4)

• 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.

  PMID: 18350967 BACKGROUND

• Gooley JJ. Treatment of circadian rhythm sleep disorders with light. Ann Acad Med Singap. 2008 Aug;37(8):669-76.

  PMID: 18797560 BACKGROUND

• 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.

  PMID: 18845459 BACKGROUND

• 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.

  PMID: 9562922 BACKGROUND

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Katarina ML Danielsson, M.D.

  Sleep department, Uppsala University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

• Agneta Markstroem, Ass. Prof.

  Sleep department, Uppsala University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

• Jan-Erik Broman, Ass. Prof.

  Sleep department, Uppsala University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

• Markus Jansson-Fröjmark, Ass. Prof.

  Department of Psychology, Stockholm University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Ph.D student.

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: August 18, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 25, 2013

Record last verified: 2013-04

Locations

SE (1)