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

Not Applicable

Completed

• Conditions: Insomnia Chronic; Insomnia Due to Mental Disorder; Sleep Initiation and Maintenance Disorders; Sleep Disturbance; Sleep Disorder; Psychological Disorder; Insomnia; Depression, Anxiety; Insomnia, Psychophysiological; Mental Illness
• Interventions: Behavioral: Cognitive behavioral therapy for insomnia (CBTi)

• Registration Number: NCT04598425
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-22
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive behavioral therapy for insomnia (CBTi)	Cognitive behavioral therapy for insomnia (CBTi)	-

Primary Outcome Measures

Name	Time	Method
Change in severity 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.	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.
Change 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.	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

Name	Time	Method
Change in daytime rumination about tiredness and negative consequences of lack of 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.	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.
Change 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.	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.
Change in somatic 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.	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.
Change 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.	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.
Change in sleep efficiency	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.
Change 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.	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.
Change 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.	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.

Trial Locations

Locations (1)

Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway; 🇳🇴 Oslo, Norway