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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04598672
• Other study ID #: 2017/516 (PVO OUS)
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Disease
• Dyssomnias
• Insomnia
• Insomnia Chronic
• Insomnia Due to Medical Condition
• Insomnia, Psychophysiological
• Parasomnias
• Sleep Disorder
• Sleep Disturbance
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Behavioral:
• Cognitive behavioral therapy for insomnia (CBTi)
Patients will undergo a 7 sessions course in cognitive behavioral therapy for insomnia.

Locations

Country	Name	City	State
Norway	Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.]
Secondary	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
Secondary	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