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Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Mental Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04598425
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 in patients with co-morbid mental illness and sleeping difficulties is a frequent complaint in most psychological disorders. Mental illness may cause sleep problems, however, sleep problems like insomnia, may also cause or exacerbate mental illness. Insomnia may aggravate symptoms of depression, anxiety and fatigue, and reduce daily functioning in patients with co-morbid insomnia and mental illness. This project aims to evaluate a course offered to patients with insomnia and mental illness 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 Insomnia Due to Mental Disorder Insomnia, Psychophysiological Sleep Disorder Sleep Initiation and Maintenance Disorders Sleep Disturbance Mental Illness Psychological Disorder Depression, Anxiety 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 Mental Illness
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

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 a 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 to 65 Years   (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 mental illness.
  • Is a patient and receiving treatment for mental illness at Department of Psychiatry, Diakonhjemmet Hospital, at time of referral to the course

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 type I
  • Mental retardation or dementia
  • Known substance abuse
  • Other sleep disorder, e.g. narcolepsy and 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): NCT04598425


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: NCT04598425    
Other Study ID Numbers: 00058 (PVO DS)
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 mental illness
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
Mental Disorders
Pathologic Processes
Sleep Disorders, Intrinsic
Nervous System Diseases
Neurologic Manifestations