Acute Psychological Sleep Stabilisation for Patients Hospitalised with Depression

Not Applicable

• Conditions: Insomnia; Depression
• Interventions: Behavioral: Acute psychological sleep stabilization; Behavioral: Sleep hygiene education

• Registration Number: NCT06145555
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Status Verified: 2025-02
• Study Start: 2025-02-17
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acute psychological sleep stabilization	Acute psychological sleep stabilization	The basis of the treatment is CBT-I adapted to a short version performed by trained staff (nurses or mental health care assistants), with support from 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). Systematic work with light / darkness based on mapping of the patient's circadian rhythm is included.
Sleep hygiene education	Sleep hygiene education	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).

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	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.

Secondary Outcome Measures

Name	Time	Method
Generalised Anxiety Disorder 7-item scale (GAD-7)	Day 4, 7, 10 14 and week 4 and 12 post randomisation	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.
European Quality of Life 5 Dimensions scale (EQ-5D)	Week 2, 4 and 12 post randomisation	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.
Patient Health Questionnaire (PHQ-9)	Day 4, 7, 10 14 and week 4 and 12 post randomisation	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.

Trial Locations

Locations (1)

Psykiatri Sydväst, Karolinska Hospital Huddinge; 🇸🇪 Stockholm, Sweden