Effectiveness of Cognitive Behavioral Therapy for sleeplessness in adolescents
| ISRCTN | ISRCTN33922163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33922163 |
| Secondary identifying numbers | NL3182701810 |
- Submission date
- 12/10/2012
- Registration date
- 14/11/2012
- Last edited
- 21/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Scientific
Universiteit van Amsterdam
Nieuwe Prinsengracht 130
Amsterdam
1018 VZ
Netherlands
| Phone | +31 (0)20 525 1327 |
|---|---|
| eddebruin@uva.nl |
Study information
| Study design | Randomised wait list controlled parallel-group multi-site trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.slimslapen.nl [Dutch] |
| 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(s) | Medical Ethical Committee of the Academic Medical Center, Amsterdam (AMC), 18/05/2010, ref: NL3182701810 |
| 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 |
| 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 study start date | 01/10/2010 |
| Overall study end date | 01/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | 50 per group, in total 150 participants |
| Total final enrolment | 116 |
| 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 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
Study participating centre
1018 VZ
Netherlands
Sponsor information
Government
Postbox 93 245
The Hague
2509 AE
Netherlands
| info@zonmw.nl | |
| Website | http://www.zonmw.nl/en/ |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2015 | Yes | No | |
| Results article | results | 01/12/2015 | Yes | No | |
| Results article | results | 01/08/2016 | Yes | No | |
| Results article | results | 01/05/2018 | 21/10/2019 | Yes | No |
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.
