As part of the development of the guided web-based self-help intervention for insomnia we want to conduct a pilot study. The aim is twofold: (1)we want to know how satisfied people are with this course. Specific questions are: what are theā¦
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main focus in this pilot study is to learn from the experience of the
participants in order to improve our course. We will focus on the website
(navigation through the course etc) as well as on the course (is the
information clearly presented, are the excercises useful etc). To explore these
topics all participants will be sent a questionnaire after they finished the
intervention.
Secondary outcome
The second aim of the study is to determine possible effects. We will measure:
(1) sleep estimates such as sleep efficiency, sleep onset latency, total sleep
time, slee quality, use of benzodiazepines; (2) subjective evaluation of the
severity of the insomnia (3) fatigue (4) anxiety (5) depression (6) quality of
life.
Background summary
Insomnia is a common problem: about one third of the general population suffers
from one or more symptoms [1]. About 10% of the general population suffers from
daytime consequences due to these symptoms, including daytime fatigue,
difficulties in cognitive performance, mood swings and psychological distress
[1*2]. Insomnia often leads to a reduced quality of life, a diminished work
productivity and absenteeism. Furthermore, it is frequently associated with
other physical and psychiatric conditions.
Treatment ususally consists of prescribing benzodiazpines. Unfortunately, there
are a number of important side effects associated with use of hypnotics such as
confusion, falls, traffic accidents and cognitive decline. The GP guidelines
therefore recommend to refrain from prescribing sleep medication. However,
there are no good alternatives. Even though research has indicated that
face-to-face sleep therapy (based on cognitive behavioral therapy) is at least
as effective as benzodiazepinen, sleep therapists are almost unavailable in the
Netherlands.
Therapists in other countries (US, UK, Sweden) have converted this sleep
therapy in selfhelp format (book or Internet). A recent meta-analyses
demonstrated that these selfhelp therapies are effective in reducing sleep
problems. Selfhelp therapies might enhance access to evidence-based sleep
therapy.
Study objective
As part of the development of the guided web-based self-help intervention for
insomnia we want to conduct a pilot study. The aim is twofold: (1)we want to
know how satisfied people are with this course. Specific questions are: what
are the characteristics of the users? What is the drop-out rate? Which elements
of the course are most useful? And which elements are least useful? (2) We like
to have some indication of possible effects. Specific questions are: is there a
reduction in sleeping problems? Is there a reduction in the use of sleep
medication?
Based on the experience of the participants we will optimise the intervention.
Study design
We will perform a randomised trial (RCT). We will recruit 100 participants
through newspapers and Internet. Participants will be randomly assigned to: the
web-based intervention or a waiting list. Participants are asked to fill out a
baseline questionnaire and follow up measurements will take place 6 and 13
weeks thereafter. Participants on the waiting list can start the intervention
after the last follow up measurement.
Intervention
The course will be offered through the Internet and consists of 6 weekly
lessons. The following topics will be discussed: psycho-education, sleep
hygiene, improve sleep-wake rhythm, rumination, relaxation, and dysfunctional
cognitive thoughts. The course consists of information and excercise. A coach
will give weekly feedback through e-mail.
Study burden and risks
n/a
van der Boechorststraat 1
1081 BT Amsterdam
NL
van der Boechorststraat 1
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
18 years and older
sleep problem (at least 3 nights a week awake for 30 minutes per night or more for at least 3 months)
Exclusion criteria
severe symptoms of anxiety or depression
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL29947.029.09 |
OMON | NL-OMON27579 |