There are three main questions:1. How effective is internet treatment of insomnia in adolescents compared with group treatment of insomnia and control groups?2. Are the principles of cognitive behavioral therapy of insomnia in adolescents correct?3…
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome measures: statistically significant improvement between baseline and
follow-up measurements on different scales from questionnaires that measure
social and behavioral problems, significant improvements in sleep variables,
sleep duration, sleep efficiency and sleep quality, and significant improvement
of costs associated with and affected by sleep (school, grades, illness, doctor
visits, etc.).
Secondary outcome
Not applicable
Background summary
From the literature it is known that many adolescents have sleep problems.
Estimations are that 15-50% have problems falling asleep or waking up after
sleep onset and 4-5% suffer from insomnia as diagnosed according to the DSM-IV.
Cognitive behavioral therapy has been proven effective in the treatment of
insomnia in adults. This treatment consists of a combination of four parts:
sleep hygiene, stimulus control, sleep restriction and relaxation. Based on
effect studies these techniques are recommended by the American Academy of
Sleep Medicine as effective therapy for insomnia and where sleep hygiene was
seen as a promising. From studies it is known that efficacy of cognitive
behavioral therapy in the short term is comparable to medication and on the
long term it is comparable or even better than medication. However, almost no
effect studies for this treatment with adolescents have been published. In a
research with 55 adolescents results from a cognitive behavioral therapy showed
a significant improvement of sleep. There was also a significant decrease of
worrying and improvement of mental health. However, so far no effect studies
have been conducted for adolescents with insomnia in the Netherlands. Also cost
effectiveness of this treatment for insomnia in adolescents has not been
researched. Based on this information, for this research it is hypothesized
that adolescents with insomnia after treatment with cognitive behavioral
therapy in group sessions and through the internet, compared to no treatment,
will improve in sleep, will show a decrease in social and behavioral problems,
will show higher cost effectiveness, and these effects will be comparable
between group therapy and internet therapy.
Study objective
There are three main questions:
1. How effective is internet treatment of insomnia in adolescents compared with
group treatment of insomnia and control groups?
2. Are the principles of cognitive behavioral therapy of insomnia in
adolescents correct?
3. How cost-effective is internet treatment of insomnia in adolescents compared
with group treatment of insomnia and control groups?
Purpose of the study is to develop an internet treatment for insomnia, to
determine and compare effectiveness of internet therapy and group therapy, and
then to incorporate these treatments into the database of effective youth
interventions of the NJI. After the study, these treatments will be made
available for use in the practice of treatment.
Study design
The study is designed in a randomized controlled trial with an open structure
with parallel groups that get internet cognitive behavioral therapy and group
cognitive behavioral therapy, and two waiting list groups. The first waiting
list group records sleep using a sleep diary as is done in the treatment
groups. As this registration is known to affect sleep there is another waiting
list group that keeps a minimal record of sleep in a sleep diary for the
synchronization of the actometers.
Intervention
For 6 weeks the two treatment groups have cognitive behavioral therapy for
insomnia in 6 counseling sessions and two months after a follow-up a booster
session. In the internet condition this therapy consists of digital internet
counseling through a website. In group therapy the treatment consists of face
to face group sessions. Each session is approximately one and a half hours.
The therapy consists of:
Sleep Hygiene in which all factors that negatively affect sleep are optimized.
These include setting a regular bedtime, limiting excessive light before sleep,
limiting noise, limiting coffee and other stimulating drinks, limiting daytime
naps and two hours prior to sleep restricting activities to quiet and relaxing
activities (eg no exercise or sports during the evening).
Stimulus control: the client leaves the bed and sleeping environment for a
short while when awake for longer than 20 minutes, so sleep will be dissociated
from the bed and sleeping environment.
Sleep Restriction: the client gets bedtimes from the therapist that come as
close as possible to an optimal sleep efficiency. This means a reduction of the
bed time to a value close to the time they actually sleep. This creates a
slightly elevated sleep pressure by which the client falls asleep easier, and
the fragmentation of sleep that is characteristic of insomnia decreases.
Stress reduction through relaxation: the client gets some relaxation exercises
that reduce stress and tension that are associated with sleep.
Study burden and risks
The burden consists of completing the questionnaires at each measurement time.
In the treatment groups this consists of 5 measurements and in the control
groups of 3 measurements because after the 3rd time the controls get the
opportunity to follow one of the therapies. Completion of these questionnaire
takes approximately 45 minutes each time. In addition, participants keep a
daily sleep diary prior to the intake and over the course of one weeks each
measurement time, and during all weeks of treatment. In total there are 70 days
to complete a diary. It takes 2 minutes each time to fill out the diary. All
questionnaires and sleep diaries are filled out via the Internet. Participants
will also make a recording of sleep through the use of actometers. An actometer
is a small instrument which is similar to a wristwatch that is worn during the
time in bed and keeps record of movements. This record is a reliable measure of
sleep parameters. Also, prior to treatment, an intake will be conducted with
all participants of approximately 45 minutes duration, for an anamnesis and
further information on the research. Furthermore, participants in the treatment
conditions will get a counseling session each week for 6 weeks and a booster
session two months after, each of approximately one and a half hour.
This study is bound to the group of adolescents aged 13 to 19 years with
insomnia since the treatment of adolescents may have specific characteristics
that differ from adults and that could influence effectiveness. There are no
expected negative side effects of treatment. It is important to determine the
effectiveness of treatment compared with a control group. Therefore, for three
months after the intake the participants in the control groups are given no
treatment. After that period the importance of the measurements is smaller and
the participants from the control groups can follow one of the two treatments
according to their own choice.
Nieuwe Prinsengracht 130
1018 VZ, Amsterdam
NL
Nieuwe Prinsengracht 130
1018 VZ, Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Sleep disturbances (insomnia) according to the diagnostic criteria from the Diagnostic and Statistical Manual (DSM-IV), age between 13 and 19.
Exclusion criteria
No diagnosed or apparent other psychological or psychiatric disturbances, no use of sleep medication or other medication that influences sleep (for instance medication for mood-disorders), no excessive drug or alcohol use.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL31827.018.10 |