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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598425
• Other study ID #: 00058 (PVO DS)
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2022
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression, Anxiety
• Disease
• Dyssomnias
• Insomnia
• Insomnia Chronic
• Insomnia Due to Mental Disorder
• Insomnia, Psychophysiological
• Mental Disorders
• Mental Illness
• Parasomnias
• Psychological Disorder
• Sleep Disorder
• Sleep Disturbance
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Behavioral:
• Cognitive behavioral therapy for insomnia (CBTi)
Patients will undergo a 7 sessions course in cognitive behavioral therapy for insomnia.

Locations

Country	Name	City	State
Norway	Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.