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

• Sponsor: Diakonhjemmet Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04598672
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 54.9
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia; Insomnia Chronic; Sleep Initiation and Maintenance Disorders; Sleep Disorder; Sleep Disturbance; Chronic Disease; Insomnia Due to Medical Condition; Insomnia, Psychophysiological	Behavioral: Cognitive behavioral therapy for insomnia (CBTi)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease
• Actual Study Start Date: Jan 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive behavioral therapy for insomnia (CBTi)	Behavioral: Cognitive behavioral therapy for insomnia (CBTi); Patients will undergo a 7 sessions course in cognitive behavioral therapy for insomnia.

Outcome Measures

Primary Outcome Measures

1. Change in severity 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.]

   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.

2. Change 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.]

   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

1. Change in sleep efficiency [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.]

   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.

2. Change 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.]

   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.

3. Change in daytime rumination about tiredness and negative consequences of lack of 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.]

   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.

4. Change 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.]

   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.

5. Change 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.]]

   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.

6. Change 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]

   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.

7. Change in somatic 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]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway	Oslo		Norway

Sponsors and Collaborators

• Diakonhjemmet Hospital

Investigators

• Principal Investigator: Kåre Osnes, M.D., Ph.D., Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kåre Osnes, Principal investigator, Diakonhjemmet Hospital
• ClinicalTrials.gov Identifier: NCT04598672
• Other Study ID Numbers: 2017/516 (PVO OUS)
• First Posted: Oct 22, 2020
• Last Update Posted: Feb 4, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kåre Osnes, Principal investigator, Diakonhjemmet Hospital: Insomnia; Insomnia and co-morbid somatic disease; Cognitive behavioral therapy for insomnia; CBTi
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias; Disease; Chronic Disease

Study Results

No Results Posted as of Feb 4, 2021