Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia (COSTS)

January 16, 2026 updated by: Jimmi Nielsen

Using a randomized controlled design, the project aims to test if cognitive behavioral therapy interventions specifically targeting sleep disorders can significantly lessen the burden of the disrupted sleep in patients with treatment resistant schizophrenia (TRS) and by proxy lead to a reduction in psychotic symptoms and improvement in quality of life.

We are including treatment-resistant patients with schizophrenia other nonorganic and chronic psychoses and in addition meeting the criteria of a sleep or circadian disorder. Included patients will be block randomized to either 8-10 sessions of CBT-I (active treatment) with a specific focus on sleep or 8-10 sessions of regularCBT with a specific focus on patients' psychopathology (treatment as usual) approx.1 session/week.

After 12 weeks the full battery of assessments will be repeated forboth groups. Primary analyses will be to identify group-difference in changes using repeated measure ANOVA.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with ICD-10 schizophrenia (DF20), chronic paranoid psychosis (DF22), schizo-affective disorder (DF25) or other non-organic psychosis (DF28-DF29)
  • Treatment resistance according to TRRIP criteria
  • Sleeping difficulties (minimum duration 3 months)
  • ISI score >14
  • Stable psychopharmacological treatment the last month
  • Only legal competent patient can participant

Exclusion Criteria:

  • Psychiatric admission last six months (more than 1 week or resulted in significant changes in psychopharmacological treatment)
  • Substance abuse to a degree that will interfere with participation.
  • Diagnoses of sleep apnea/CPAP use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Therapy for insomnia
8-10 sessions CBT-I tailored for insomnia symptoms
Other: CBT-I
Cognitive therapy tailored for insomnia symptoms.
Other Names:
  • Cognitive behavioral therapy for insomnia
Active Comparator: Cognitive Behavioral Therapy
8-10 sessions CBT tailored for general psychopathology
Other: CBT
Cognitive behavioral therapy for general psychopathology
Other Names:
  • Cognitive behavioral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia severity index
Time Frame: Baseline, after 12-weeks and 24-weeks.
Patient-entered questionnaire measuring sleep difficulties. Seven items. Range of score 0-28. Higher scores indicate more severe insomnia.
Baseline, after 12-weeks and 24-weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and negative syndrome scale (PANSS)
Time Frame: Baseline, after 12-weeks and 24-weeks.
32-items clinician administered rating scale measuring psychopathology. Range of score 30-210. Higher scores indicate higher level of symptoms
Baseline, after 12-weeks and 24-weeks.
WHO well being index
Time Frame: Baseline, after 12-weeks and 24-weeks.
5-five items patient-entered questionnaire. Measuring quality of life. Range of score 0-100. Higher scores indicate better quality of life.
Baseline, after 12-weeks and 24-weeks.
Global Assessment of Functioning (GAF)
Time Frame: Baseline, after 12-weeks and 24-weeks.
Rating scale measuring level of functioning. Clinician administered. Range of score 0-100. Higher scores indicate higher level of functioning.
Baseline, after 12-weeks and 24-weeks.
Functioning Assessment Short Test (FAST)
Time Frame: Baseline, after 12-weeks and 24-weeks.
Clinician administered rating scale measuring level of functioning. Range of score 0-72. Higher scores indicate lower level of functioning.
Baseline, after 12-weeks and 24-weeks.
Personal and Social Performance scale
Time Frame: Baseline, after 12-weeks and 24-weeks.
Semi-structured interview. Measuring level of functioning. Range of score 0-100. Higher scores indicate higher level of functioning.
Baseline, after 12-weeks and 24-weeks.
Process of recovery questionnaire (QPR)
Time Frame: Baseline, after 12-weeks and 24-weeks.
Questionnaire. Range 0-60. Higher scores indicate better outcome.
Baseline, after 12-weeks and 24-weeks.
Sleep onset latency (PSG)
Time Frame: Baseline and after 12-weeks.
Time until sleep verified by polysomnography. Measured in minutes. Increasing number is associated with poorer sleep.
Baseline and after 12-weeks.
Sleep efficiency (PSG)
Time Frame: Baseline and after 12-weeks.
Time with verified sleep divided by Time spent in bed and multiplied by 100. Measured by polysomnography. Higher percentage is associated with better sleep quality.
Baseline and after 12-weeks.
Wake after sleep onset, number of awakenings (PSG)
Time Frame: Baseline and after 12-weeks.
Number of wake periods after initial onset of sleep. Measured in number of awakenings . Higher number is associated with poorer sleep quality.
Baseline and after 12-weeks.
Wake after sleep onset, duration of wake periods (PSG)
Time Frame: Baseline and after 12-weeks.
Duration of wake periods after initial onset of sleep. Measured in minutes of duration. Longer duration is associated with poorer sleep quality.
Baseline and after 12-weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jimmi Nielsen

Investigators

  • Study Director: Jimmi Nielsen, MD, Psykiatrisk Center Glostrup

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24002249
  • 10.46540/3166-00056B (Other Grant/Funding Number: DFF: Independent Research Fund Denmark)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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