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Clinical Trials/NCT04598425
NCT04598425
Completed
Not Applicable

Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Mental Illness

Diakonhjemmet Hospital1 site in 1 country40 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insomnia
Sponsor
Diakonhjemmet Hospital
Enrollment
40
Locations
1
Primary Endpoint
Change in severity of insomnia
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Insomnia is common in patients with co-morbid mental illness and sleeping difficulties is a frequent complaint in most psychological disorders. Mental illness may cause sleep problems, however, sleep problems like insomnia, may also cause or exacerbate mental illness. Insomnia may aggravate symptoms of depression, anxiety and fatigue, and reduce daily functioning in patients with co-morbid insomnia and mental illness. This project aims to evaluate a course offered to patients with insomnia and mental illness at Diakonhjemmet Hospital. The course is based on cognitive behavioral therapy, a documented treatment for insomnia.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
August 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Diakonhjemmet Hospital
Responsible Party
Principal Investigator
Principal Investigator

Kåre Osnes

Principal Investigator

Diakonhjemmet Hospital

Eligibility Criteria

Inclusion Criteria

  • Men and women over 18 years with insomnia and co-morbid mental illness.
  • Is a patient and receiving treatment for mental illness at Department of Psychiatry, Diakonhjemmet Hospital, at time of referral to the course

Exclusion Criteria

  • Unable to provide informed consent
  • Unable to read and/or understand Norwegian
  • Unable to complete a survey
  • Severe mental disorder, e.g. schizophrenia and bipolar disorder type I
  • Mental retardation or dementia
  • Known substance abuse
  • Other sleep disorder, e.g. narcolepsy and hypersomnia

Outcomes

Primary Outcomes

Change in severity of insomnia

Time Frame: At baseline (before first session), at session 6 (last ordinary session, 5-7 weeks after baseline), at session 7 (2 months after last ordinary session) and 6 months after completing the course.

All patients included in the study will be asked to complete the Insomnia Severity Index (ISI; Minimum value = 0; Maximum value = 4. Higher scores mean worse outcome) to assess for any changes in symptoms of insomnia.

Change in symptoms of insomnia

Time Frame: At baseline (before first session), at session 6 (last ordinary session, 5-7 weeks after baseline), at session 7 (2 months after last ordinary session) and 6 months after completing the course.

All patients included in the study will be asked to complete the Bergen Insomnia Scale ( Minimum value = 0; Maximum value = 7. Higher scores mean worse outcome) to assess for any changes in symptoms of insomnia.

Secondary Outcomes

  • Change in daytime rumination about tiredness and negative consequences of lack of sleep(At baseline (before first session), at session 6 (last ordinary session, 5-7 weeks after baseline), at session 7 (2 months after last ordinary session) and 6 months after completing the course.)
  • Change in symptoms of depression(At baseline (before first session), at session 6 (last ordinary session, 5-7 weeks after baseline), at session 7 (2 months after last ordinary session) and 6 months after completing the course.)
  • Change in somatic symptoms(At baseline (before first session), at session 6 (last ordinary session, 5-7 weeks after baseline), at session 7 (2 months after last ordinary session) and 6 months after completing the course.)
  • Change in symptoms of anxiety(At baseline (before first session), at session 6 (last ordinary session, 5-7 weeks after baseline), at session 7 (2 months after last ordinary session) and 6 months after completing the course.)
  • Change in sleep efficiency(Calculations of sleep efficiency at baseline (before first session), at session 6 (last ordinary session, 5-7 weeks after baseline), at session 7 (2 months after last ordinary session) and 6 months after completing the course, will be compared.)
  • Change in dysfunctional beliefs and attitudes about sleep(At baseline (before first session), at session 6 (last ordinary session, 5-7 weeks after baseline), at session 7 (2 months after last ordinary session) and 6 months after completing the course.)
  • Change in compliance with sleep hygiene measures(At baseline (before first session), at session 6 (last ordinary session, 5-7 weeks after baseline), at session 7 (2 months after last ordinary session) and 6 months after completing the course.)

Study Sites (1)

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