Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression

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 Overview

• Status: Enrolling by invitation
• Conditions: Depression; Insomnia
• Intervention / Treatment: Behavioral: Acute psychological sleep stabilization; Behavioral: Sleep hygiene education

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Psykiatri Sydväst, Karolinska Hospital Huddinge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Behavioral: Sleep hygiene education; See above (arm description)
Experimental: 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) 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).	Behavioral: Acute psychological sleep stabilization; See above (arm description)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Side effects of treatment	Patients will be asked to report any side-effects of the treatment with an open question	Day 7 and 14 post randomisation

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Sandra Tamm, Karolinska Institutet; Principal Investigator: Susanna Jernelöv, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Sleep; Psychiatry; CBT; Inpatient care
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: Dnr 2023-02223-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No