Ireland
--:--IST
Latest
Clinical Trials in Sweden / NCT06145555
Enrolling by invitation Not applicable

Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression

NCT06145555 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2025-03-07
Last updated
2025-07-01

Condition(s) studied

InsomniaDepression

Investigational drug(s) / intervention(s)

Acute psychological sleep stabilizationSleep hygiene education

Acute psychological sleep stabilization: See above (arm description)

Sleep hygiene education: See above (arm description)

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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) Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Psykiatri Sydväst, Karolinska Hospital Huddinge Stockholm Sweden

More Karolinska Institutet trials in Sweden

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06145555 on ClinicalTrials.gov ↗ ← All trials in Sweden