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Completed

NCT Number: NCT04598672

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

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.

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Key information

Conditions

Insomnia Chronic Disease Disease Attributes Dyssomnias Insomnia Chronic Insomnia Due to Medical Condition Insomnia, Psychophysiological Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Disorders, Intrinsic Sleep Disturbance Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for insomnia (CBTi)

Behavioral

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

Primary outcomes

  1. Change in severity 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.

    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

    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.

    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 outcomes

  1. Change in sleep efficiency

    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.

    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

    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.

    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

    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.

    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

    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.

    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

    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.]

    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

    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

    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

    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

    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

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2025
First posted
Oct 22, 2020
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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