Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease

NCT ID: NCT04598672

Last Updated: 2024-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-12-31

Brief Summary

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Insomnia is common with co-morbid somatic disease, e.g. rheumatic disease, cancer, heart and lung disease or gastrointestinal disorders. Pain, breathing difficulties and other symptoms of disease can worsen sleep problems and cause insomnia. In turn, insomnia may aggravate pain, fatigue and reduce quality of life in patients with somatic disorders. This project aims to evaluate a course offered to patients with insomnia and somatic disease at Diakonhjemmet Hospital. The course is based on cognitive behavioral therapy, a documented treatment for insomnia.

Detailed Description

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Conditions

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Insomnia Insomnia Chronic Sleep Initiation and Maintenance Disorders Sleep Disorder Sleep Disturbance Chronic Disease Insomnia Due to Medical Condition Insomnia, Psychophysiological

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive behavioral therapy for insomnia (CBTi)

Group Type EXPERIMENTAL

Cognitive behavioral therapy for insomnia (CBTi)

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive behavioral therapy for insomnia (CBTi)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Men and women over 18 years with insomnia and co-morbid somatic disease.

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
* Mental retardation or dementia
* Known substance abuse
* Sleep disorders, e.g. narcolepsy or hypersomnia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diakonhjemmet Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kåre Osnes

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kåre Osnes, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

Locations

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Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2017/516 (PVO OUS)

Identifier Type: -

Identifier Source: org_study_id

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