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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Disturbance, Insomnia, Insomnia Chronic, Insomnia Due to Mental Disorder, Insomnia, Psychophysiological, Sleep Disorder, Sleep Initiation and Maintenance Disorders, Mental Illness, Psychological Disorder, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy for insomnia (CBTi)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioral therapy for insomnia (CBTi)<br> | Behavioral: Cognitive behavioral therapy for insomnia (CBTi)<br>* Patients will undergo a 7 sessions course in cognitive behavioral therapy for insomnia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep efficiency | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 anxiety | 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. | 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 somatic symptoms | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Insomnia and co-morbid mental illness, Cognitive behavioral therapy for insomnia, CBTi