Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease

Study Overview
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Brief Summary
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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.

Official Title
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Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease

Conditions
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Insomnia, Insomnia Chronic, Sleep Initiation and Maintenance Disorders, Sleep Disorder, Sleep Disturbance, Chronic Disease, Insomnia Due to Medical Condition, Insomnia, Psychophysiological

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy for insomnia (CBTi)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioral therapy for insomnia (CBTi)<br> | Behavioral: Cognitive behavioral therapy for insomnia (CBTi)<br>* Patients will undergo a 7 sessions course in cognitive behavioral therapy for insomnia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of insomnia | 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. | 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 insomnia | 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep efficiency | All patients included in the study will be asked to keep at sleep diary for the whole duration of the course. Sleep efficiency will be calculated based on the sleep diary. | 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 | All patients included in the study will be asked to complete the Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16; Minimum = 0; Maximum = 10. Higher values mean worse outcome) to assess for any changes 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 daytime rumination about tiredness and negative consequences of lack of sleep | All patients included in the study will be asked to complete the Daytime Insomnia Symptom Response Scale (DISRS; Minimum = 1; Maximum = 4. Higher values mean worse outcome) to assess for any changes in rumination about insomnia 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 compliance with sleep hygiene measures | All patients included in the study will be asked to complete the Sleep Hygiene Index (SHI-13; Minimum value = 1; Maximum value = 5. Higher values mean worse outcome) to assess for any changes 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. | 
| Change in symptoms of depression | All patients included in the study will be asked to complete the Patient Health Questionnaire-9 (PHQ-9; Minimum value = 0; Maximum value = 3. Higher values mean worse outcome) to assess for any changes 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 symptoms of anxiety | All patients included in the study will be asked to complete the Generalized Anxiety Disorder Scale-7 (GAD-7; Minimum value = 0; Maximum value = 3. Higher values mean worse outcome) to assess for any changes 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 somatic symptoms | All patients included in the study will be asked to complete the Somatic Symptom Scale-9 (SSS-8; Minimum value = 0; Maximum value = 4. Higher value mean worse outcome) to assess for any changes in somatic symptom burden | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Insomnia and co-morbid somatic disease, Cognitive behavioral therapy for insomnia, CBTi