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

Primary Purpose

Delayed Sleep Phase Syndrome

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Light therapy and Cognitive behaviour therapy
Light therapy
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Sleep Phase Syndrome focused on measuring Light therapy, circadian rhythm, CBT

Eligibility Criteria

16 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of delayed sleep phase syndrome.

Exclusion Criteria:

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

Sites / Locations

  • Sleep department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Light therapy for two weeks

Light therapy and CBT

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes from baseline in sleep-diary at 6 weeks.
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 Hospital anxiety-depression scale at 2 weeks
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Change from baseline in Hospital anxiety-depression scale at 6 weeks
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Change from baseline in Hospital anxiety-depression scale at 6 months
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Change from baseline in Insomnia Severity Scale at 2 weeks
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Change from baseline in Insomnia Severity Scale at 6 weeks
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Change from baseline in Insomnia Severity Scale at 6 months
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Change from baseline in Epworth Sleepiness Scale at 2 weeks
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Change from baseline in Epworth Sleepiness Scale at 6 weeks
By comparing the results of the questionnaires before study start, during and after study completion, knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Change from baseline in Epworth Sleepiness Scale at 6 months
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Change from baseline in Penn State Worry Questionnaire at 6 months
By comparing the results of the questionnaire before study start and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Change from baseline in Symptom-focused Rumination Scale at 6 months
By comparing the results of the questionnaire before study start and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Change from baseline in Brief COPE at 6 months
By comparing the results of the questionnaire before study start and after study completion. Knowledge about this patient group's coping strategies will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Change from baseline in sleep-diary at 2 weeks
That the patients will go to bed before 01:00 and wake up not later than 09:00 a.m. or earlier
Number of participants that will keep their new sleep-timings.
We want to measure how many participants that can keep their new sleep-timings after the first treatment (6 weeks). We believe that CBT or light-therapy intermittently can help these patients to avoid relapses
Change from baseline in Horne-Ostberg Morning-Eveningness Questionnaire at 6 months
By comparing the results of the questionnaire before study start and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.

Full Information

First Posted
July 26, 2011
Last Updated
April 24, 2013
Sponsor
Uppsala University
Collaborators
Uppsala County Council, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01419938
Brief Title
Does Cognitive Behaviour Therapy (CBT) Improve the Effect of Light Therapy
Official Title
Does CBT Improve the Effect of Light Therapy in Delayed Sleep Phase Syndrome Compared to Only Light Therapy - Short and Long Term Follow up
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
Collaborators
Uppsala County Council, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
DSPS patients delayed sleep and wake times are accompanied by insomnia and excessive sleepiness that results in functional impairments. The sleeping-problems and the impairment in important areas of functioning and quality of life sometimes lead to psychiatric problems such as, depressive symptoms, irritability, problems with their memory and concentration. It has not yet been fully established how long the treatment should go on, how long each light treatment should be, and the exact intensity of light. Although long-term studies on DSPS patients are sparse, it is known from clinical experience that these patients often fall back into their old circadian schedule after the treatment. This study is a prospective randomised study. In the short-term study patients will be randomised to two groups. Group I light therapy (LT) for two weeks Group II LT for two weeks + CBT for four weeks. Group I and II will be followed up with questionnaires concerning depression/anxiety, sleepiness during the day, sleep-diary and insomnia-problems. The aim is to evaluate if CBT enhance LT-treatment at home. The two groups will be followed with sleep-diary monthly and questionnaires. Method. Questionnaires. All patients will fill in some questionnaires before the treatment starts, during treatment and at follow-up. I) Horne-Ostberg Morning-Eveningness Questionnaire (MEQ) to measure their diurnality. II) Insomnia Severity Scale (ISI), a scale that measures the severity of insomnia III) Epworth Sleepiness Scale (ESS), a scale that measures habitual daytime sleepiness. IV) Hospital anxiety- depression scale (HADS) V) Penn state Worry Questionnaire (PSWQ) VI)Symptom-focused Rumination Scale (SRS) VII) Brief COPE(BC) The same questionaires will be given to a matched reference group, but without sleeping problems. Light therapy: It is today considered that the most effective light intensity is 10 000 lux at approximately one foot from the person and during 30-45 minutes. This treatment will be applied at home. The exact time schedule for the light treatment will be decided individually depending on the patient's sleep diary. Each day the time for light therapy will be brought back one hour earlier and thereby getting out of bed. CBT will be given for 90-120 minutes by a psychologist once per week for four weeks at our Sleep Department. The therapy will be given in groups of 4-6 persons. DLMO. DLMO will only be taken before the study starts to evaluate the shift in circadian rhythm. DLMO is the time when endogenous melatonin reaches a threshold of 3 ng/L or 4 ng/L in saliva. To measure melatonin in saliva is the most commonly used way to determine DLMO since it is both easy and safe for the patient and it gives a value that follows the melatonin blood-value, only it is three times lower. The saliva test will be taken hourly for about five hours, during a window when we suspect DLMO to appear. It is important that the saliva collection must be done under dim light conditions (less then 10 lux).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Sleep Phase Syndrome
Keywords
Light therapy, circadian rhythm, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Light therapy for two weeks
Arm Type
Active Comparator
Arm Title
Light therapy and CBT
Arm Type
Active Comparator
Arm Description
Two weeks of light therapy and after that 4 weeks of Cognitive behaviour therapy (CBT)
Intervention Type
Device
Intervention Name(s)
Light therapy and Cognitive behaviour therapy
Intervention Description
Light therapy every morning during 30 minutes for two weeks. CBT for 90 to 120 minutes weekly during four weeks.
Intervention Type
Device
Intervention Name(s)
Light therapy
Intervention Description
Light therapy every morning during 30-45 minutes for two weeks.
Primary Outcome Measure Information:
Title
Change from baseline in sleep-diary at 6 months.
Description
That the patients will go to bed before 01:00 and wake up not later than 09:00 a.m. or earlier.
Time Frame
Change from baseline in sleep-diary at 6 months.
Secondary Outcome Measure Information:
Title
Changes from baseline in sleep-diary at 6 weeks.
Description
That the patients will go to bed before 01:00 and wake up not later than 09:00 a.m. or earlier.
Time Frame
Changes from baseline in sleep diary at 6 weeks.
Title
Change from baseline in Hospital anxiety-depression scale at 2 weeks
Description
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Hospital anxiety-depression scale at 2 weeks
Title
Change from baseline in Hospital anxiety-depression scale at 6 weeks
Description
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Hospital anxiety-depression scale at 6 weeks
Title
Change from baseline in Hospital anxiety-depression scale at 6 months
Description
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Hospital anxiety-depression scale at 6 months
Title
Change from baseline in Insomnia Severity Scale at 2 weeks
Description
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Insomnia Severity Scale at 2 weeks
Title
Change from baseline in Insomnia Severity Scale at 6 weeks
Description
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Insomnia Severity Scale at 6 weeks
Title
Change from baseline in Insomnia Severity Scale at 6 months
Description
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Insomnia Severity Scale at 6 months
Title
Change from baseline in Epworth Sleepiness Scale at 2 weeks
Description
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Epworth Sleepiness Scale at 2 weeks
Title
Change from baseline in Epworth Sleepiness Scale at 6 weeks
Description
By comparing the results of the questionnaires before study start, during and after study completion, knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Epworth Sleepiness Scale at 6 weeks
Title
Change from baseline in Epworth Sleepiness Scale at 6 months
Description
By comparing the results of the questionnaires before study start, during and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Epworth Sleepiness Scale at 6 months
Title
Change from baseline in Penn State Worry Questionnaire at 6 months
Description
By comparing the results of the questionnaire before study start and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Penn State Worry Questionnaire at 6 months
Title
Change from baseline in Symptom-focused Rumination Scale at 6 months
Description
By comparing the results of the questionnaire before study start and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Symptom-focused Rumination Scale at 6 months
Title
Change from baseline in Brief COPE at 6 months
Description
By comparing the results of the questionnaire before study start and after study completion. Knowledge about this patient group's coping strategies will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Brief COPE at 6 months
Title
Change from baseline in sleep-diary at 2 weeks
Description
That the patients will go to bed before 01:00 and wake up not later than 09:00 a.m. or earlier
Time Frame
Change from baseline in sleep-diary at 2 weeks
Title
Number of participants that will keep their new sleep-timings.
Description
We want to measure how many participants that can keep their new sleep-timings after the first treatment (6 weeks). We believe that CBT or light-therapy intermittently can help these patients to avoid relapses
Time Frame
6 months
Title
Change from baseline in Horne-Ostberg Morning-Eveningness Questionnaire at 6 months
Description
By comparing the results of the questionnaire before study start and after study completion. Knowledge about this patient group will provide clinical routines to treat patients with DSPS. The results will also be compared with a matched reference-group.
Time Frame
Change from baseline in Horne-Ostberg Morning-Eveningness Questionnaire at 6 months
Other Pre-specified Outcome Measures:
Title
Does DLMO correlate with sleep diary
Description
A part of a second study. About the importance of DLMO. Since DLMO has been measured in this patient group at baseline
Time Frame
baseline
Title
Is DLMO important for setting the time to start light therapy
Description
Is a sleep diary enough or is DLMO important to decide the time to start Light therapy in the morning.
Time Frame
From baseline to 2 weeks
Title
Is scores in MEQ important to decide when to start light therapy in the morning.
Description
Is scores in MEQ important to decide when to start light therapy in the morning. and are scores in MEQ correlated with DLMO and sleep diary
Time Frame
from baseline to 2 weeks of Light therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of delayed sleep phase syndrome. Exclusion Criteria: Eye diseases Active psychiatric disorder. Ongoing somatic disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarina ML Danielsson, M.D.
Organizational Affiliation
Sleep department, Uppsala University Hospital, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Agneta Markstroem, Ass. Prof.
Organizational Affiliation
Sleep department, Uppsala University Hospital, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan-Erik Broman, Ass. Prof.
Organizational Affiliation
Sleep department, Uppsala University Hospital, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markus Jansson-Fröjmark, Ass. Prof.
Organizational Affiliation
Department of Psychology, Stockholm University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep department
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
18350967
Citation
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.
Results Reference
background
PubMed Identifier
18797560
Citation
Gooley JJ. Treatment of circadian rhythm sleep disorders with light. Ann Acad Med Singap. 2008 Aug;37(8):669-76.
Results Reference
background
PubMed Identifier
18845459
Citation
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.
Results Reference
background
PubMed Identifier
9562922
Citation
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.
Results Reference
background

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

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