Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Many adolescents suffer from trouble with sleeping because of social, hormonal and behavioral changes. Treatment for this age group however has not been researched conclusively while young people tend not to seek help with their sleep problems. For adults cognitive behavioral therapy for insomnia (CBT-i) has been proven effective to treat insomnia (sleeplessness) with long-lasting results. We investigate the effectiveness of CBT-I in adolescents and aim to implement CBT-i in an online and group setting for better accessibility.

Who can participate?
Adolescents between 13 and 19 years of age with insomnia.

What does the study involve?
For the study, three groups of adolescents are recruited of each about 50 participants. One group will receive cognitive behavioral therapy via internet sessions, the second group will get group therapy at a community health care center, and the third group will be put on a wait-list. All groups will be measured at the start of the study, directly after the treatment of 6 weeks, two months after the treatment, just before both treatment groups get one final treatment booster session, again after six months and finally after 12 months to see if the treatment is effective in the long term.

What are the possible benefits and risks of participating?
Possible benefits for participants are improvements of sleep by sleeping deeper and longer, and improvements of daily functioning that may have been impacted negatively by long-term sleep problems, like school performance and social functioning. There is no risk in participating in the study and/or having CBT-i in group or internet settings.

Where is the study run from?
The study is set up and run by the University of Amsterdam, the Netherlands in collaboration with several treatment centers in the Netherlands.

When is the study starting and how long is it expected to run for?
The study started in 2010 and will run until 2014.

Who is funding the study?
The study is funded by ZonMW, The Netherlands Organisation for Health Research and Development.

Who is the main contact?
Ed de Bruin

Trial website

Contact information



Primary contact

Mr Ed de Bruin


Contact details

Universiteit van Amsterdam
Nieuwe Prinsengracht 130
1018 VZ
+31 (0)20 525 1327

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Sleep problems of adolescents and efficacy of treatment: a study on effective and easily accessible treatment for sleep problems of adolescents


Study hypothesis

Cognitive behavioral therapy for insomnia (CBT-i) has been proven to be effective for treatment of insomnia in adults. We hypothesize CBT-i is also effective for the treatment of insomnia in adolescents and test two treatment modalities in groups and via internet therapy, which we hypothesize to be equally effective.

Ethics approval

Medical Ethical Committee of the Academic Medical Center, Amsterdam (AMC), 18/05/2010, ref: NL3182701810

Study design

Randomised wait list controlled parallel-group multi-site trial

Primary study design


Secondary study design

Randomised parallel trial

Trial setting


Trial type


Patient information sheet

Patient information can be found at: [Dutch]


Treatment for primary insomnia in adolescents


Cognitive Behavioral Therapy for insomnia in group sessions and internet sessions and a wait-list group.

Intervention type



Drug names

Primary outcome measure

1. Sleep efficiency
2. Sleep onset latency
3. Wake after sleep onset
4. Total sleep time
5. Insomnia severity
6. Chronic sleep reduction

Secondary outcome measures

1. Behavioral measures from the Youth Self Report with several scales for both internalising problem behavior (anxiety, depression etc) and externalising behavior (aggressiveness etc)
2. Dysfunctional beliefs and attitudes.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Age between 13-19
2. No other psychiatric disorders at present or under treatment for this
3. Difficulty initiating or maintaining sleep, or not feeling rested after the night
4. More than 3 days a week sleep problems, for more than 1 month
5. Problems in daily life (academic, social functioning etc) due to the sleep problems
6. Sleep problems not due to other sleep disturbances (like apnea or circadian rhythm sleep disorder), nor due to drugs or medication, nor due to a physical disorder
7. Living within traveling distance to one of the treatment centers and willing to take part in group therapy

Participant type


Age group




Target number of participants

50 per group, in total 150 participants

Total final enrolment


Participant exclusion criteria

Other psychiatric disorders, drug use, treatment for a psychiatric disorder, physical conditions
that interfere with good sleep

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Universiteit van Amsterdam
1018 VZ

Sponsor information


The Netherlands Organisation for Health Research and Development [ZonMw] (Netherlands)

Sponsor details

Postbox 93 245
The Hague
2509 AE

Sponsor type




Funder type


Funder name

Netherlands Organisation for Health Research and Development

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations



Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2015 results in:
2015 results in:
2016 results in:
2018 results in (added 21/10/2019)

Publication citations

Additional files

Editorial Notes

21/10/2019: The following changes were made: 1. Publication reference added. 2. The final enrolment number was added from the reference. 17/06/2016: Publication reference added. 11/04/2016: Publication reference added.