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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22798
Enrollment
110
Registered
2019-08-08
Start date
2017-06-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Chronic insomnia

Interventions

Cognitive behavioral therapy for insomnia (CBT-i) versus waiting list

Sponsors

GGZ Drenthe Mental Health Institute, Zorgondersteuningsfonds
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Insomnia severity as measured by self report questionnaire (ISI). Objective sleep efficiency as measured by actigraphy.

Secondary

MeasureTime frame
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)

Contacts

Public ContactMaaike Van Veen

GGZ Drenthe Mental Health Institute

maaike.van.veen@ggzdrenthe.nl+31 6 30053458

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)