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

NCT04598425 | Completed

• 1 other identifier: 00058 (PVO DS)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Insomnia; Insomnia and co-morbid mental illness; Cognitive behavioral therapy for insomnia; CBTi

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

Cognitive behavioral therapy for insomnia (CBTi)

EXPERIMENTAL

Behavioral: Cognitive behavioral therapy for insomnia (CBTi)

Interventions

Cognitive behavioral therapy for insomnia (CBTi) BEHAVIORAL

Patients will undergo a 7 sessions course in cognitive behavioral therapy for insomnia.

Cognitive behavioral therapy for insomnia (CBTi)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (1)

Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

Oslo, Norway

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Mental Disorders; Depression; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kåre Osnes, M.D., Ph.D.

  Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: October 22, 2020
• Study Start: August 1, 2018
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)