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

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ClinicalTrials.gov Identifier: NCT04598672
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Kåre Osnes, Diakonhjemmet Hospital

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598672


Contacts
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Contact: Kåre Osnes, M.D., Ph.D. 0047 22029800 Kare.Osnes@diakonsyk.no

Locations
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Norway
Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway Recruiting
Oslo, Norway
Contact: Kåre Osnes, M.D., Ph.D.    0047 22029800    Kare.Osnes@diakonsyk.no   
Sponsors and Collaborators
Diakonhjemmet Hospital
Investigators
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Principal Investigator: Kåre Osnes, M.D., Ph.D. Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway
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Responsible Party: Kåre Osnes, Principal investigator, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT04598672    
Other Study ID Numbers: 2017/516 (PVO OUS)
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kåre Osnes, Diakonhjemmet Hospital:
Insomnia
Insomnia and co-morbid somatic disease
Cognitive behavioral therapy for insomnia
CBTi
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Parasomnias
Dyssomnias
Disease
Chronic Disease
Pathologic Processes
Sleep Disorders, Intrinsic
Nervous System Diseases
Mental Disorders
Disease Attributes
Neurologic Manifestations