Clinical trial NCT04598672: Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease
Official title: Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insomnia
Insomnia Chronic
Sleep Initiation and Maintenance Disorders
Sleep Disorder
Sleep Disturbance
Chronic Disease
Insomnia Due to Medical Condition
Insomnia, Psychophysiological
Keywords: Insomnia
Insomnia and co-morbid somatic disease
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
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Insomnia is common with co-morbid somatic disease, e.g. rheumatic disease, cancer, heart and lung disease or gastrointestinal disorders. Pain, breathing difficulties and other symptoms of disease can worsen sleep problems and cause insomnia. In turn, insomnia may aggravate pain, fatigue and reduce quality of life in patients with somatic disorders. This project aims to evaluate a course offered to patients with insomnia and somatic disease 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 somatic disease.

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
* Mental retardation or dementia
* Known substance abuse
* Sleep disorders, e.g. narcolepsy or 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: