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Randomised controlled trial of the effects of cognitive behavioral therapy for insomnia on sleep, impulsivity and aggression in forensic psychiatric patients

Randomised controlled trial of the effects of cognitive behavioral therapy for insomnia on sleep, impulsivity and aggression in forensic psychiatric patients - Treatment of insomnia in forensic patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46929
Enrollment
110
Registered
2016-08-22
Start date
2017-06-22
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia sleep problems

Interventions

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.

Sponsors

GGZ Drenthe (Assen)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Insomnia severity as measured by self report questionnaire. Objective information on sleep efficiency as measured by actigraphy.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)