InsomniaNCT06145555
Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression
A study testing Acute psychological sleep stabilization and Sleep hygiene education in people with Insomnia and Depression, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Disturbed sleep occurs in almost all patients in psychiatric inpatient care, and although it is well known that comorbid sleep disorders in depression often persist after treatment of depression and also increase the risk of new depressive episodes, the availability of effective, evidence-based treatments for sleep… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Depression
- What is being tested?
- Acute psychological sleep stabilization and Sleep hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 7 Mar 2025to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the psychiatric inpatient care (Psykiatri Sydväst)
- Depressive symptoms / confirmed depressive episode (uni- or bipolar)
- Reports or is observed to have sleep problems in the form of insomnia, hypersomnia or delayed circadian phase
- Knowledge of Swedish or English that is deemed sufficient to undergo the treatment
- Consent to be included in the study and is judged to have understood what the study entails (care according to the Compulsory Psychiatric Care Act is not in itself an exclusion criterion)
Who cannot join
- Dementia
- Intellectual disability
- Severe somatic comorbidity with life expectancy <6 months
- Ongoing mania / mixed-state
- Complex problems that make APS impossible or inappropriate
- Expected discharge within 3 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Disturbed sleep occurs in almost all patients in psychiatric inpatient care, and although it is well known that comorbid sleep disorders in depression often persist after treatment of depression and also increase the risk of new depressive episodes, the availability of effective, evidence-based treatments for sleep disorders in hospitalised patients is very limited.
The overall goal of the current project is to translate, adapt and evaluate an acute psychological sleep treatment based on cognitive behavioural therapy for insomnia (CBT-I) for patients hospitalized with depression and comorbid sleep problems in the specialized psychiatric inpatient care in the Stockholm Region. The main hypothesis for the study is that acute psychological sleep stabilization (APS) reduces self-reported sleep complains compared to care as usual reinforced with sleep hygiene advice, and secondary hypotheses are that APS also leads to reduced depressive symptoms and earlier discharge.
The project includes a pilot study, which will be followed by a randomized, controlled trial of APS compared to care as usual with structured sleep hygiene (minimal active control) and treatment effect is evaluated every three days during the hospital stay and 1,2,4 and 12 weeks after randomization. APS will be performed by existing staff in the department with the support of a psychologist.
- Conditions
- Insomnia, Depression
- Being tested
- Acute psychological sleep stabilization, Sleep hygiene education
- Keywords
- CBT, Psychiatry, Inpatient care, Sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute psychological sleep stabilizationBehavioural
See above (arm description)
Sleep hygiene educationBehavioural
See above (arm description)
| Study group | Role | What they receive |
|---|---|---|
| Acute psychological sleep stabilization | Experimental | The basis of the treatment is CBT-I adapted to a short version performed by trained staff (nurses or mental health care assistants) together with a psychologist. The manuals are designed to be read by patients and staff together and each treatment manual covers a specific topic. The focus of the treatment is behavioral changes and central manuals are stimulus control and scheduled sleep and sleep compression (if needed). Receives: Behavioral: Acute psychological sleep stabilization |
| Sleep hygiene education | Active comparator | The control treatment is delivered through structured manuals which patients work through together with the staff. The manuals cover sleep hindering factors (eg coffee, nicotine), sleep promoting factors (eg physical activity during the day, relaxation, blinds), sleep aids (for example, weight blanket, calm music). Receives: Behavioral: Sleep hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
A self-report measure of insomnia symptoms. 7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.
Measured: 2 weeks post randomization (secondary timepoints include day 4, 7, 10 and week 4 and 12)
Secondary outcomes (3)
Patient Health Questionnaire (PHQ-9)
Self-reported depressive symptoms. PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Total score 0-27, higher score indicates more severe depressive symptoms.
Measured: Day 4, 7, 10 14 and week 4 and 12 post randomisation
Generalised Anxiety Disorder 7-item scale (GAD-7)
Self-reported anxiety symptoms. A seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder/symptoms. Total score 0-27. Higher scores indicative of more severe problem.
Measured: Day 4, 7, 10 14 and week 4 and 12 post randomisation
European Quality of Life 5 Dimensions scale (EQ-5D)
Self-reported quality of life. An instrument which evaluates the generic quality of life developed in Europe and widely used. The scale comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: Week 2, 4 and 12 post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start7 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Sandra Tamm, Karolinska Institutet
- Investigators
- Sandra Tamm, Principal investigator, Karolinska InstitutetSusanna Jernelöv, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145555
- Sponsor's protocol ID
- Dnr 2023-02223-01
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression
- ClinicalTrials.gov ID
- NCT06145555
- Acronym / sponsor ID
- Dnr 2023-02223-01
- Conditions
- Insomnia, Depression
- Keywords
- CBT, Psychiatry, Inpatient care, Sleep
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Nov 2023 (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.
Disturbed sleep occurs in almost all patients in psychiatric inpatient care, and although it is well known that comorbid sleep disorders in depression often persist after treatment of depression and also increase the risk of new depressive episodes, the availability of effective, evidence-based treatments for sleep disorders in hospitalised patients is very limited.
The overall goal of the current project is to translate, adapt and evaluate an acute psychological sleep treatment based on cognitive behavioural therapy for insomnia (CBT-I) for patients hospitalized with depression and comorbid sleep problems in the specialized psychiatric inpatient care in the Stockholm Region. The main hypothesis for the study is that acute psychological sleep stabilization (APS) reduces self-reported sleep complains compared to care as usual reinforced with sleep hygiene advice, and secondary hypotheses are that APS also leads to reduced depressive symptoms and earlier discharge.
The project includes a pilot study, which will be followed by a randomized, controlled trial of APS compared to care as usual with structured sleep hygiene (minimal active control) and treatment effect is evaluated every three days during the hospital stay and 1,2,4 and 12 weeks after randomization. APS will be performed by existing staff in the department with the support of a psychologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute psychological sleep stabilization | Experimental | Behavioral: Acute psychological sleep stabilizationThe basis of the treatment is CBT-I adapted to a short version performed by trained staff (nurses or mental health care assistants) together with a psychologist. The manuals are designed to be read by patients and staff together and each treatment manual covers a specific topic. The focus of the treatment is behavioral changes and central manuals are stimulus control and scheduled sleep and sleep compression (if needed). |
| Sleep hygiene education | Active comparator | Behavioral: Sleep hygiene educationThe control treatment is delivered through structured manuals which patients work through together with the staff. The manuals cover sleep hindering factors (eg coffee, nicotine), sleep promoting factors (eg physical activity during the day, relaxation, blinds), sleep aids (for example, weight blanket, calm music). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admitted to the psychiatric inpatient care (Psykiatri Sydväst)
- Depressive symptoms / confirmed depressive episode (uni- or bipolar)
- Reports or is observed to have sleep problems in the form of insomnia, hypersomnia or delayed circadian phase
- Knowledge of Swedish or English that is deemed sufficient to undergo the treatment
- Consent to be included in the study and is judged to have understood what the study entails (care according to the Compulsory Psychiatric Care Act is not in itself an exclusion criterion)
Key exclusion criteria (6 listed)
- Dementia
- Intellectual disability
- Severe somatic comorbidity with life expectancy <6 months
- Ongoing mania / mixed-state
- Complex problems that make APS impossible or inappropriate
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 |
|---|---|---|
| Acute psychological sleep stabilizationSee above (arm description) | Behavioural | Acute psychological sleep stabilization |
| Sleep hygiene educationSee above (arm description) | Behavioural | Sleep hygiene education |
Primary outcome
Insomnia Severity Index
Time frame: 2 weeks post randomization (secondary timepoints include day 4, 7, 10 and week 4 and 12)
A self-report measure of insomnia symptoms. 7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.
3 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: Day 4, 7, 10 14 and week 4 and 12 post randomisation
Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: Day 4, 7, 10 14 and week 4 and 12 post randomisation
European Quality of Life 5 Dimensions scale (EQ-5D)
Time frame: Week 2, 4 and 12 post randomisation
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 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual data will not be shared
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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.
Sandra Tamm principal investigator
Karolinska Institutet
Susanna Jernelöv principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute psychological sleep stabilization and Sleep hygiene education in people with Insomnia and Depression, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 4 Nov 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 Sweden. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: 2 weeks post randomization (secondary timepoints include day 4, 7, 10 and week 4 and 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.