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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Cognitive behavioral therapy for insomnia (CBTi)

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Insomnia and co-morbid mental illness, Cognitive behavioral therapy for insomnia, CBTi

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive behavioral therapy for insomnia (CBTi)

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04598425

First Posted

July 6, 2020

Last Updated

September 29, 2022

Sponsor

Diakonhjemmet Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04598425

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

August 31, 2021 (Actual)

Study Completion Date

August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Diakonhjemmet Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive behavioral therapy for insomnia (CBTi)

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Cognitive behavioral therapy for insomnia (CBTi)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in severity of insomnia

Description

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.

Time Frame

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.

Title

Change in symptoms of insomnia

Description

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.

Time Frame

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 Measure Information:

Title

Change in sleep efficiency

Description

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.

Time Frame

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.

Title

Change in dysfunctional beliefs and attitudes about sleep

Description

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.

Time Frame

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.

Title

Change in daytime rumination about tiredness and negative consequences of lack of sleep

Description

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.

Time Frame

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.

Title

Change in compliance with sleep hygiene measures

Description

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.

Time Frame

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.

Title

Change in symptoms of depression

Description

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.

Time Frame

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.

Title

Change in symptoms of anxiety

Description

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.

Time Frame

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.

Title

Change in somatic symptoms

Description

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.

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kåre Osnes, M.D., Ph.D.

Organizational Affiliation

Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

City

Oslo

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

No

Insomnia, Insomnia Chronic, Insomnia Due to Mental Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial