The objective of this study is the effectiveness of a cognitive-behavioural therapy for insomnia in inpatient abstinent patients in addiction care.
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the effectiveness of a cognitive-behavioural
intervention for insomniacs in addiction care, expressed by the sleep
efficiency (from the sleep log) and the sleep quality (from the PSQI).
Secondary outcome
Vigilance measured by the SART is a secondary study parameters.
Background summary
Many studies show that sleep disturbances are a common substance withdrawal
symptom. Although this is acknowledged by many researchers and practitioners,
little is known about treatment of sleep disturbances in addiction care. This
study hopes to contribute to the well being of the patients during their stay
in an addiction clinic, by testing the effectiveness of a non-pharmacological
treatment for sleep disturbances. Furthermore this study will reveal more
knowledge about the sleep related substance withdrawal symptoms of alcohol and
drugs.
Study objective
The objective of this study is the effectiveness of a cognitive-behavioural
therapy for insomnia in inpatient abstinent patients in addiction care.
Study design
The study is a randomized clinical trial in a cohort of patients referred to
clinical addiction care.
Intervention
In this study one intervention of group cognitive behavioural therapy (CBT)
will be tested. The intervention was originally designed by Dr. H.M.J.C.
Verbeek for people who met the criteria for chronic primary insomnia according
to the DSM IV-R and the ICSD.
The CBT for insomnia consists of 6 sessions of two hours:
• General information about insomnia, sleep and addictive drug use, goal
setting and sleep hygiene.
• Behavioural component: sleep restriction and stimulus control.
• Behavioural and cognitive components: cognitive restructuring.
• Behavioural and cognitive components: relaxation.
• Review of all therapy components; programming generalisation of newly learned
skills and thought stopping
• Evaluation; identification of high-risk situations and review of relapse
prevention strategies
Study burden and risks
The risks for the patients participating in this study is negligible. The
experimental group is expected to benefit from the treatment.
The control-group will not recieve any treatment for sleeping problems. They
are pree to consult the researcher for their sleeping problems. The medical
examiner can decide to start te patient on slaap-medication when necessary. The
data will be gathered according to the intention-to-treat principle.
Wanssumseweg 12
5807 EA Oostrum
NL
Wanssumseweg 12
5807 EA Oostrum
NL
Listed location countries
Age
Inclusion criteria
All patients that are voluntarily admitted to the addiction clinic, that give there informed consent, that are between 18 and 65 years of age and have a well enough understanding of the Dutch language to fulfil the questionnaires and meet the criteria for difficulties of initiating or maintaining sleep according to the clinical cut-off point of the PSQI, which is a score of 5 or more on the PSQI, enroll in the clinical trail.
Exclusion criteria
Patients that have an active history of addiction to sleep medication in the last three months before admittance to the clinic and still have a current use of that medication are excluded.
Patients that are presented with sleeping disorders that need pharmacological intervention or that have a pure physiological nature (all disorders other than insomnia) are excluded.
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 |
|---|---|
| Other | ISRTCN: CCT-NAPN-17824 |
| CCMO | NL22929.097.08 |