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

NCT04598672 | Completed

• 1 other identifier: 2017/516 (PVO OUS)
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.]

Study Arms (1)

Cognitive behavioral therapy for insomnia (CBTi)

EXPERIMENTAL

Behavioral: Cognitive behavioral therapy for insomnia (CBTi)

Interventions

Cognitive behavioral therapy for insomnia (CBTi) BEHAVIORAL

Patients will undergo a 7 sessions course in cognitive behavioral therapy for insomnia.

Cognitive behavioral therapy for insomnia (CBTi)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years with insomnia and co-morbid somatic disease.

You may not qualify if:

• 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

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (1)

Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

Oslo, Norway

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Chronic Disease

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kåre Osnes, M.D., Ph.D.

  Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: October 22, 2020
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)