The objective of this study is to determine whether providing feedback enhances self-help CBT for insomnia.
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diary sleep measures
Secondary outcome
Anxiety rating; Depression rating; Sleep medication
Background summary
Insomnia is a common disorder with a prevalence of 10-15%. 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 all sleep disordered persons seeks and gets
adequate treatment, most likely due to a shortage of well trained health
professionals. Insomnia, however, can be effectively treated. Two
meta-analysis, and two systematic reviews concluded that for insomnia,
non-pharmacological therapy in the form of cognitive behavioral 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
behavioral therapy for several mental disorders may only be met by less
intensive approaches than standard face-to-face therapy, such as self-help
interventions. Self-help CBT is effective in treating insomnia complaints,
however, not all patients benefit from this treatment. Support on progress and
feedback might encourage more patients to complete all exercises. This RCT
addresses whether feedback can enhance the effects of self-help CBT for
insomnia
Study objective
The objective of this study is to determine whether providing feedback enhances
self-help CBT for insomnia.
Study design
All participants will receive a web-based intervention (N = 300). Participants
will be randomized into two groups: 1) intervention with feedback; 2)
intervention without feedback.
Intervention
In this study all participants receive an online self-help CBT manual
consisting of information (psycho-education) about sleep and
cognitive-behavioral 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 eight hours; otherwise I*ll be
a wreck tomorrow).
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
NL
Postbus 80.140
3508TC Utrecht
NL
Listed location countries
Age
Inclusion criteria
- Suffering from insomnia
- Acces to internet
- A valid e-mail addess
Exclusion criteria
Being suicidal; schizophrenic or having a psychotic 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 | NL36297.041.11 |