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ID
Source
Brief title
Health condition
Chronic insomnia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Insomnia severity as measured by self report questionnaire (ISI). Objective sleep efficiency as measured by actigraphy.
Secondary outcome
General psychopathology and level of impulsivity and aggression as measured by self report questionnaires (SCL-90, BIS and AQ)
Objective evaluation of level of impulsivity as measured by neuropsychological testing (Stop Signal Task and Iowa Gambling Task)
Taxation of risk of possible aggressive incidents by the treating physician (START)
Background summary
Background: 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 reduces impulsivity and aggression.
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 (Stop Signal Task and 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.
Study objective
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 reduces impulsivity and aggression.
Study design
weeks 0 ( pre-treatment), 7 (post-treatment), 14 (follow-up), (21 (only for waiting list: post-treatment))
Intervention
Cognitive behavioral therapy for insomnia (CBT-i) versus waiting list
Inclusion criteria
Male subjects between 18 and 55 years of age, currently under treatment by a forensic psychiatric facility.
Chronic insomnia (assessed by interview and Sleep Diagnosis Questionnaire (SDQ))
Exclusion criteria
Comorbid sleep disorders as RLS or sleep apnea (assessed by interview and Sleep Diagnosis Questionnaire (SDQ))
No objective impulsivity or hostility ((assessed by HKT-30)
Severe concurrent psychiatric illness or behavioral disorders requiring acute safety measures, interfering with ability to participate
Insufficient understanding of the Dutch language, disabling them to complete the questionnaires and neuropsychological task
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7943 |
| Other | METC, Isala Zwolle, the Netherlands : 16.0356 |