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

• Sponsor: Diakonhjemmet Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04598425
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 41
• Patients Per Site Per Month: 1

Study Details

Study Description

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)	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Aug 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway	Oslo		Norway

Sponsors and Collaborators

• Diakonhjemmet Hospital

Investigators

• Principal Investigator: Kåre Osnes, M.D., Ph.D., Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kåre Osnes, Principal Investigator, Diakonhjemmet Hospital
• ClinicalTrials.gov Identifier: NCT04598425
• Other Study ID Numbers: 00058 (PVO DS)
• First Posted: Oct 22, 2020
• Last Update Posted: Oct 22, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kåre Osnes, Principal Investigator, Diakonhjemmet Hospital: Insomnia; Insomnia and co-morbid mental illness; Cognitive behavioral therapy for insomnia; CBTi
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias; Disease; Mental Disorders

Study Results

No Results Posted as of Oct 22, 2020