Treatment-refractory SchizophreniaCOSTSNCT06749444
Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
A study testing CBT-I and CBT in people with Treatment-refractory Schizophrenia and Treatment-resistant Schizophrenia, run by Jimmi Nielsen at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Treatment-refractory Schizophrenia, Treatment-resistant Schizophrenia
- What is being tested?
- CBT-I and CBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Nov 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jeppe F Johansen (investigator), Psychologist contact
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Centre Glostrup
Glostrup, Denmark
Jeppe F Johansen, Psychologist, +4538640885, jeppe.feigenberg.johansen@regionh.dk
Jimmi Nielsen, MD, +4531326403, jimmi.nielsen@regionh.dk
About this study
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.
- Being tested
- CBT-I, CBT
- Keywords
- Cognitive, CBT, Therapy, Insomnia, polysomnography
- Medical subject headings
- Schizophrenia, Treatment-Resistant, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IOther
Also called Cognitive behavioral therapy for insomnia
Cognitive therapy tailored for insomnia symptoms.
CBTOther
Also called Cognitive behavioral therapy
Cognitive behavioral therapy for general psychopathology
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for insomnia | Experimental | 8-10 sessions CBT-I tailored for insomnia symptoms Receives: Other: CBT-I |
| Cognitive Behavioral Therapy | Active comparator | 8-10 sessions CBT tailored for general psychopathology Receives: Other: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity index
Patient-entered questionnaire measuring sleep difficulties. Seven items. Range of score 0-28. Higher scores indicate more severe insomnia.
Measured: Baseline, after 12-weeks and 24-weeks.
Secondary outcomes (10)
Positive and negative syndrome scale (PANSS)
32-items clinician administered rating scale measuring psychopathology. Range of score 30-210. Higher scores indicate higher level of symptoms
Measured: Baseline, after 12-weeks and 24-weeks.
WHO well being index
5-five items patient-entered questionnaire. Measuring quality of life. Range of score 0-100. Higher scores indicate better quality of life.
Measured: Baseline, after 12-weeks and 24-weeks.
Global Assessment of Functioning (GAF)
Rating scale measuring level of functioning. Clinician administered. Range of score 0-100. Higher scores indicate higher level of functioning.
Measured: Baseline, after 12-weeks and 24-weeks.
Functioning Assessment Short Test (FAST)
Clinician administered rating scale measuring level of functioning. Range of score 0-72. Higher scores indicate lower level of functioning.
Measured: Baseline, after 12-weeks and 24-weeks.
Personal and Social Performance scale
Semi-structured interview. Measuring level of functioning. Range of score 0-100. Higher scores indicate higher level of functioning.
Measured: Baseline, after 12-weeks and 24-weeks.
Process of recovery questionnaire (QPR)
Questionnaire. Range 0-60. Higher scores indicate better outcome.
Measured: Baseline, after 12-weeks and 24-weeks.
Sleep onset latency (PSG)
Time until sleep verified by polysomnography. Measured in minutes. Increasing number is associated with poorer sleep.
Measured: Baseline and after 12-weeks.
Sleep efficiency (PSG)
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.
Measured: Baseline and after 12-weeks.
Wake after sleep onset, number of awakenings (PSG)
Number of wake periods after initial onset of sleep. Measured in number of awakenings . Higher number is associated with poorer sleep quality.
Measured: Baseline and after 12-weeks.
Wake after sleep onset, duration of wake periods (PSG)
Duration of wake periods after initial onset of sleep. Measured in minutes of duration. Longer duration is associated with poorer sleep quality.
Measured: Baseline and after 12-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start28 Nov 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Treatment-refractory SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jimmi Nielsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jimmi Nielsen, Copenhagen University Hospital, Hvidovre
- Investigators
- Jimmi Nielsen, MD, Study director, Psykiatrisk Center Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749444
- Sponsor's protocol ID
- H-24002249
- Other IDs
- 10.46540/3166-00056B
- Acronym
- COSTS
- Status last verified
- Aug 2025
- First submitted
- 12 Dec 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freeman D, Waite F, Startup H, Myers E, Lister R, McInerney J, Harvey AG, Geddes J, Zaiwalla Z, Luengo-Fernandez R, Foster R, Clifton L, Yu LM. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial. Lancet Psychiatry. 2015 Nov;2(11):975-83. doi: 10.1016/S2215-0366(15)00314-4. Epub 2015 Sep 9.
PubMed 26363701Kaskie RE, Graziano B, Ferrarelli F. Schizophrenia and sleep disorders: links, risks, and management challenges. Nat Sci Sleep. 2017 Sep 21;9:227-239. doi: 10.2147/NSS.S121076. eCollection 2017.
PubMed 29033618Nucifora FC Jr, Woznica E, Lee BJ, Cascella N, Sawa A. Treatment resistant schizophrenia: Clinical, biological, and therapeutic perspectives. Neurobiol Dis. 2019 Nov;131:104257. doi: 10.1016/j.nbd.2018.08.016. Epub 2018 Aug 29.
PubMed 30170114Reeve S, Sheaves B, Freeman D. Sleep Disorders in Early Psychosis: Incidence, Severity, and Association With Clinical Symptoms. Schizophr Bull. 2019 Mar 7;45(2):287-295. doi: 10.1093/schbul/sby129.
PubMed 30202909Robertson I, Cheung A, Fan X. Insomnia in patients with schizophrenia: current understanding and treatment options. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Jun 8;92:235-242. doi: 10.1016/j.pnpbp.2019.01.016. Epub 2019 Jan 29.
PubMed 30707986Johansen JF, Nielsen MO, Kragh M, Nielsen J. Cognitive behavioral therapy for insomnia vs. standard cognitive behavioral therapy for sleep and circadian disturbances in treatment-resistant schizophrenia: study protocol for the randomized controlled trial (COSTS). Trials. 2026 Apr 17;27(1):309. doi: 10.1186/s13063-026-09482-0.
PubMed 41998739
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia
- ClinicalTrials.gov ID
- NCT06749444
- Acronym / sponsor ID
- COSTS / H-24002249
- Keywords
- Cognitive, CBT, Therapy, Insomnia, polysomnography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jimmi NielsenUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for insomnia | Experimental | Other: CBT-I8-10 sessions CBT-I tailored for insomnia symptoms |
| Cognitive Behavioral Therapy | Active comparator | Other: CBT8-10 sessions CBT tailored for general psychopathology |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-IAlso: Cognitive behavioral therapy for insomniaCognitive therapy tailored for insomnia symptoms. | Other | Cognitive Behavioral Therapy for insomnia |
| CBTAlso: Cognitive behavioral therapyCognitive behavioral therapy for general psychopathology | Other | Cognitive Behavioral Therapy |
Primary outcome
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.
10 secondary outcomes
Positive and negative syndrome scale (PANSS)
Time frame: Baseline, after 12-weeks and 24-weeks.
WHO well being index
Time frame: Baseline, after 12-weeks and 24-weeks.
Global Assessment of Functioning (GAF)
Time frame: Baseline, after 12-weeks and 24-weeks.
Functioning Assessment Short Test (FAST)
Time frame: Baseline, after 12-weeks and 24-weeks.
Personal and Social Performance scale
Time frame: Baseline, after 12-weeks and 24-weeks.
Process of recovery questionnaire (QPR)
Time frame: Baseline, after 12-weeks and 24-weeks.
Sleep onset latency (PSG)
Time frame: Baseline and after 12-weeks.
Sleep efficiency (PSG)
Time frame: Baseline and after 12-weeks.
Wake after sleep onset, number of awakenings (PSG)
Time frame: Baseline and after 12-weeks.
Wake after sleep onset, duration of wake periods (PSG)
Time frame: Baseline and after 12-weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 26363701Freeman D, Waite F, Startup H, Myers E, Lister R, McInerney J, Harvey AG, Geddes J, Zaiwalla Z, Luengo-Fernandez R, Foster R, Clifton L, Yu LM. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial. Lancet Psychiatry. 2015 Nov;2(11):975-83. doi: 10.1016/S2215-0366(15)00314-4. Epub 2015 Sep 9.
- Background: PubMed 29033618Kaskie RE, Graziano B, Ferrarelli F. Schizophrenia and sleep disorders: links, risks, and management challenges. Nat Sci Sleep. 2017 Sep 21;9:227-239. doi: 10.2147/NSS.S121076. eCollection 2017.
- Background: PubMed 30170114Nucifora FC Jr, Woznica E, Lee BJ, Cascella N, Sawa A. Treatment resistant schizophrenia: Clinical, biological, and therapeutic perspectives. Neurobiol Dis. 2019 Nov;131:104257. doi: 10.1016/j.nbd.2018.08.016. Epub 2018 Aug 29.
- Background: PubMed 30202909Reeve S, Sheaves B, Freeman D. Sleep Disorders in Early Psychosis: Incidence, Severity, and Association With Clinical Symptoms. Schizophr Bull. 2019 Mar 7;45(2):287-295. doi: 10.1093/schbul/sby129.
- Background: PubMed 30707986Robertson I, Cheung A, Fan X. Insomnia in patients with schizophrenia: current understanding and treatment options. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Jun 8;92:235-242. doi: 10.1016/j.pnpbp.2019.01.016. Epub 2019 Jan 29.
- Derived from this study: PubMed 41998739Johansen JF, Nielsen MO, Kragh M, Nielsen J. Cognitive behavioral therapy for insomnia vs. standard cognitive behavioral therapy for sleep and circadian disturbances in treatment-resistant schizophrenia: study protocol for the randomized controlled trial (COSTS). Trials. 2026 Apr 17;27(1):309. doi: 10.1186/s13063-026-09482-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeppe F Johansen (investigator), Psychologist contact
Jimmi Nielsen, MD study director
Psykiatrisk Center Glostrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I and CBT in people with Treatment-refractory Schizophrenia and Treatment-resistant Schizophrenia, run by Jimmi Nielsen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeppe F Johansen (investigator), Psychologist (+4538640885, jeppe.feigenberg.johansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity index (time frame: Baseline, after 12-weeks and 24-weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06749444, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.