Clinical trial NCT04598425: Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Mental Illness
Official title: Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Insomnia Chronic
Insomnia Due to Mental Disorder
Insomnia, Psychophysiological
Sleep Disorder
Sleep Initiation and Maintenance Disorders
Sleep Disturbance
Mental Illness
Psychological Disorder
Depression, Anxiety
Keywords: Insomnia
Insomnia and co-morbid mental illness
Cognitive behavioral therapy for insomnia
CBTi
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in severity of insomnia
timeFrame: 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.
measure: Change in symptoms of insomnia
timeFrame: 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.
Secondary outcomes:
measure: Change in sleep efficiency
timeFrame: 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.
measure: Change in dysfunctional beliefs and attitudes about sleep
timeFrame: 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.
measure: Change in daytime rumination about tiredness and negative consequences of lack of sleep
timeFrame: 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.
measure: Change in compliance with sleep hygiene measures
timeFrame: 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.
measure: Change in symptoms of depression
timeFrame: 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.
measure: Change in symptoms of anxiety
timeFrame: 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.
measure: Change in somatic symptoms
timeFrame: 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.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway
Study officials:
affiliation: Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway
name: Kåre Osnes, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: