Condition category
Mental and Behavioural Disorders
Date applied
12/10/2012
Date assigned
14/11/2012
Last edited
17/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
eddebruin@uva.nl

Trial website

http://www.slimslapen.nl

Contact information

Type

Scientific

Primary contact

Mr Ed de Bruin

ORCID ID

Contact details

Universiteit van Amsterdam
Nieuwe Prinsengracht 130
Amsterdam
1018 VZ
Netherlands
+31 (0)20 525 1327
eddebruin@uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL3182701810

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

Acronym

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

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.slimslapen.nl [Dutch]

Condition

Treatment for primary insomnia in adolescents

Intervention

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

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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

01/10/2010

Overall trial end date

01/01/2014

Reason abandoned

Eligibility

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

Patient

Age group

Child

Gender

Both

Target number of participants

50 per group, in total 150 participants

Participant exclusion criteria

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

Recruitment start date

01/10/2010

Recruitment end date

01/01/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

Universiteit van Amsterdam
Amsterdam
1018 VZ
Netherlands

Sponsor information

Organisation

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

Sponsor details

Postbox 93 245
The Hague
2509 AE
Netherlands
-
info@zonmw.nl

Sponsor type

Government

Website

http://www.zonmw.nl/en/

Funders

Funder type

Government

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

Location

Netherlands

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26158889
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25796966
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27306272

Publication citations

Additional files

Editorial Notes

17/06/2016: Publication reference added. 11/04/2016: Publication reference added.