Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease
Primary Purpose
Insomnia, Insomnia Chronic, Sleep Initiation and Maintenance Disorders
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive behavioral therapy for insomnia (CBTi)
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Insomnia and co-morbid somatic disease, Cognitive behavioral therapy for insomnia, CBTi
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
Sites / Locations
- Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive behavioral therapy for insomnia (CBTi)
Arm Description
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04598672
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diakonhjemmet Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioral therapy for insomnia (CBTi)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for insomnia (CBTi)
Intervention Description
Patients will undergo a 7 sessions course in cognitive behavioral therapy for insomnia.
Primary Outcome Measure Information:
Title
Change in severity of insomnia
Description
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.
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.
Title
Change in symptoms of insomnia
Description
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
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.
Secondary Outcome Measure Information:
Title
Change in sleep efficiency
Description
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.
Time Frame
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.
Title
Change in dysfunctional beliefs and attitudes about sleep
Description
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.
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.
Title
Change in daytime rumination about tiredness and negative consequences of lack of sleep
Description
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.
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.
Title
Change in compliance with sleep hygiene measures
Description
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.
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.
Title
Change in symptoms of depression
Description
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.
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.]
Title
Change in symptoms of anxiety
Description
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.
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
Title
Change in somatic symptoms
Description
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kåre Osnes, M.D., Ph.D.
Organizational Affiliation
Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway
City
Oslo
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease
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