Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression

Depression Clinical Trial

Official title:

Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06145555
• Other study ID #: Dnr 2023-02223-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: March 2026

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: March 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Insomnia

Intervention

Behavioral:
• Acute psychological sleep stabilization
See above (arm description)
• Sleep hygiene education
See above (arm description)

Locations

Country	Name	City	State
Sweden	Psykiatri Sydväst, Karolinska Hospital Huddinge	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep Diary	Participants will report their bedtime, risetime, amount of sleep daily using a simplified version of a sleep diary. We will look at total sleep time, sleep efficiency, and timing of sleep.	0-14 days post randomisation
Other	Actigraphy	An actigraph is placed on the participant's arm for 2 weeks. It measures participants' arm-movements. An algorithm can be used to estimate sleep from movement data.Data from actigraphs will be reported and analysed	0-14 days post randomisation
Other	Side effects of treatment	Side effects will be reported using a questionnaire developed for insomnia treatments. The questionnaire contains questions e.g. about pain, sleepiness, fatigue, headache	Day 7 and 14 post randomisation
Other	Treatment Credibility Scale	A five-item version of Credibility/Expectancy Questionnaire, total score ranging from 0-50. Higher scores indicative of higher credibility.	Day 4 post randomisation
Primary	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.	2 weeks post randomization (secondary timepoints include day 4, 7, 10 and week 4 and 12)
Secondary	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.	Day 4, 7, 10 14 and week 4 and 12 post randomisation
Secondary	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.	Day 4, 7, 10 14 and week 4 and 12 post randomisation
Secondary	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.	Week 2, 4 and 12 post randomisation