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NCT Number: NCT06145555

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.

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Key information

Conditions

Insomnia Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psykiatri Sydväst, Karolinska Hospital Huddinge

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute psychological sleep stabilization

Behavioral

See above (arm description)

Sleep Hygiene Education

Behavioral

See above (arm description)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: 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.

  2. Generalised Anxiety Disorder 7-item scale (GAD-7)

    Time frame: 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.

  3. European Quality of Life 5 Dimensions scale (EQ-5D)

    Time frame: 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.

Other outcomes

  1. Sleep Diary

    Time frame: 0-14 days post randomisation

    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.

  2. Actigraphy

    Time frame: 0-14 days post randomisation

    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

  3. Side effects of treatment

    Time frame: Day 7 and 14 post randomisation

    Patients will be asked to report any side-effects of the treatment with an open question

  4. Treatment Credibility Scale

    Time frame: Day 4 post randomisation

    A five-item version of Credibility/Expectancy Questionnaire, total score ranging from 0-50. Higher scores indicative of higher credibility.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 24, 2023
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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