The object of this study is to determine the effect of a cognitive behavioral self help intervention for insomnia. It will be tested if internet delivered self-help differs from self-help via a booklet.
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Insomnia
Distress caused by insomnia
Sleep complaints
Secondary outcome
Anxiety rating
Depression Ratings
Sleep medication
Background summary
With a prevalence of 8-10% is insomnia a common disorder. Bad sleep causes
fatigue and distress during the day, furthermore insomnia is associated with
psychological problems. The problem that needs to be addressed is that,
notwithstanding their impact, sleep disorders receive little attention in the
general health care. A minority of 15% of all sleep disordered persons seeks
and gets adequate treatment, most likely due to a lack of sleep awareness by
the general public * and health professionals. Most sleep disorders, however,
can be effectively treated. Two meta-analysis, and two systematic reviews
concluded that for insomnia, non-pharmacological therapy in the form of
cognitive behavioural therapy (CBT) is the treatment-of-choice.
Problematic is that even if professionals are properly trained to treat sleep
problems, treatment may not be accessible. The growing demand for cognitive
behavioural therapy for several mental disorders) may only be met by less
intensive approaches than standard face-to-face therapy, such as self-help
interventions with or without brief consultations. To date six randomised
controlled trials found positive effects of self-help interventions. The design
of the studies did not make it possible to determine whether digitalized
self-help works better than self-help delivered by a booklet.
Study objective
The object of this study is to determine the effect of a cognitive behavioral
self help intervention for insomnia. It will be tested if internet delivered
self-help differs from self-help via a booklet.
Study design
This study has an experimental design; the type of self help will be
manipulated (internet / paper) The effects on insomnia, sleep quality and
mental complaints will be measured. Participants are randomly assigned to one
of the three conditions: two experimental (self-help / self-help with therapist
interaction), and one control (waiting list). After twelve weeks the control
group also gets a self-help intervention.
Intervention
In this study all participants finally will receive a self-help CBT manual
consisting of information (psycho-education) about sleep and
cognitive-behavioural exercises. The techniques used throughout the self-help
manual are all effective in reducing insomnia: 1) Stimulus control: patients
should only go to bed when sleepy, use the bed and bedroom for sleep (and sex)
only, maintain a regular rising time, avoid daytime naps and get out of bed and
go into another room when unable to fall asleep within 15-20 minutes (return
only when sleepy). 2) progressive muscle relaxation. 3) sleep hygiene education
(improving health and environmental factors that affect sleep). 3). Sleep
restriction, whereby participants will stay only the time in bed that they
sleep. 4) cognitive therapy to challenge and dispute incorrect and unhelpful
thoughts about sleep (e.g. I must sleep at least 8 hours, otherwise I*ll be a
wreck tomorrow). One condition will in addition to that receive minimal
therapist support.
Study burden and risks
The current study has minimal risks and it is highly unlikely that there will
be lasting negative effects. Participants may sleep a little less during the
intervention, but that is part of the treatment. This will not be problematic
as the sleep will not fall below five hours a night. The time investment for
the participants is small (seventeen hours over twelve months). In our view
conducting this study is warranted because of the probable positive effects,
the small time investment, and the low risks.
Postbus 80.140
3508TC Utrecht
Nederland
Postbus 80.140
3508TC Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Suffering from insomnia
Acces to internet
A valid e-mail addess
Exclusion criteria
Severe Depression
Being suicidal
Schizophrenic or having a psychosis episode
Regular cannabis use
Alcohol abuse
Sleep apnea
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 | NL22501.041.08 |