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NCT Number: NCT06749444

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

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.

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Key information

Conditions

Treatment-refractory Schizophrenia Dyssomnias Mental Disorders Nervous System Diseases Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Treatment-Resistant Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Treatment-resistant Schizophrenia

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-I

Other

Cognitive therapy tailored for insomnia symptoms.

Other names: Cognitive behavioral therapy for insomnia

CBT

Other

Cognitive behavioral therapy for general psychopathology

Other names: Cognitive behavioral therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Process of recovery questionnaire (QPR)

    Time frame: Baseline, after 12-weeks and 24-weeks.

    Questionnaire. Range 0-60. Higher scores indicate better outcome.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeppe F Johansen (investigator), Psychologist

CONTACT

[email protected]

+4538640885

Jimmi Nielsen, (Sponsor), MD

CONTACT

[email protected]

+4531326403

Sponsors and collaborators

Lead sponsor

Jimmi Nielsen

Other

Registry information

Acronym: COSTS

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 27, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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