Evaluating the effects of cognitive behavioral therapy for chronic insomnia (CBT-I) on sleep, general psychopathology, impulsivity and aggression in forensic psychiatric patients.
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
- Impulse control disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Insomnia severity as measured by self report questionnaire. Objective
information on sleep efficiency as measured by actigraphy.
Secondary outcome
General psychopathology and level of impulsivity and aggression as measured by
self report questionnaires. Objective evaluation of level of impulsivity as
measured by neuropsychological testing. Taxation of risk of possible aggressive
incidents by the treating physician.
Background summary
Many patients with psychiatric disorders experience sleeping problems. Sleep
disorders can be both cause and consequence of psychiatric disorders, and
contribute strongly to daily dysfunction and diminished quality of life.
Treating sleeping problems positively affects the course of psychiatric
illness. In forensic psychiatric patients, treatment of sleeping disorders
could be even more important, considering the association between quality and
quantity of sleep on one hand, and impulsivity and aggression on the other.
Poor sleep is a potential risk factor for impulsive and aggressive behavior.
Our hypothesis is that treatment of sleeping problems in forensic psychiatric
patients ameliorates sleep and general psychopathology, and reducing
impulsivity and aggression.
Study objective
Evaluating the effects of cognitive behavioral therapy for chronic insomnia
(CBT-I) on sleep, general psychopathology, impulsivity and aggression in
forensic psychiatric patients.
Study design
In this randomized controlled intervention study, subjects will undergo a
6-week protocolled treatment for insomnia. Criteria for chronic insomnia will
be assessed during a diagnostic interview. Severity of insomnia, as well as the
absence of other co-occurring sleeping disorders will be evaluated with the
Sleep Diagnosis Questionnaire (SDQ). Furthermore, a minimum score of 1 is
required on the impulsivity item and hostility item of the HKT-30 (a Dutch
adaptation of the HCR-20, a risk taxation instrument), to be able to evaluate
treatment effects. Additional information on psychiatric diagnosis and current
use of (hypnotic) medication will be extracted from the medical files.
Subsequently, subjects will be randomly assigned to either the intervention or
a waiting list condition. Subjective evaluation of sleep, general
psychopathology and level of impulsivity and aggression will be measured before
and after treatment using four self report questionnaires: the Insomnia
Severity Index (ISI), Symptom Checklist 90 (SCL-90), Barratt Impulsiveness
Scale (BIS), and Aggression Questionnaire (AQ) respectively. Objective data on
sleep characteristics and level of impulsivity will be obtained by actigraphy
and two neuropsychological tests (the Stop Signal Task and the Iowa Gambling
Task). Moreover, the treating physician will assess the possible occurrence of
aggression by using the Short Term Assessment of Risk and Treatability (START,
a risk taxation instrument). A follow-up evaluation will be carried out seven
weeks post-intervention.
Intervention
Treatment consists of individual cognitive behavioral therapy for chronic
insomnia, a protocol of weekly meetings during 6 weeks which has been validated
in psychiatric patients.
Study burden and risks
The burden of measurements is considered to be minimal. Risks, in the form of
side effects or negative effects associated with the intervention, are
considered negligible. Positive effects can be reflected by changes in study
parameters as well as improved results of treatment in general. This could have
important implications for forensic psychiatric patients considering possible
prevention of recidivism.
Dennenweg 9
Assen 9404 LA
NL
Dennenweg 9
Assen 9404 LA
NL
Listed location countries
Age
Inclusion criteria
- males between 18 - 55 years old
- currently under treatment by a forensic psychiatric facility
- chronic insomnia and score > 3 on insomnia subscale of Sleep Diagnosis Questionnaire (SDQ)
Exclusion criteria
- strong indications for other sleeping disorders (e.g. sleep apnea syndrome or restless legs syndrome). In case of SDQ scores >3 on either of these categories, symptoms of these disorders will be separately evaluated. Based on type and severity of the disorder subjects will be in- or excluded,
- a score of 0 on the clinical items K4 (impulsivity) and / or K6 (hostility) of a risk taxation intrument (HKT-30), as absence of these symptoms at baseline impedes further evaluation of effects of the intervention,
- co-occurence of severe current psychiatric symptoms impeding undergoing CBT-I
- severe behavioral problems which interfere with therapy
- insufficient comprehension of the Dutch language
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 | NL57035.075.16 |