Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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), 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. |
Behavioral: Acute psychological sleep stabilization
See above (arm description)
|
| 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)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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. Higher scores indicative of more severe problem.
- EQ-5D [Week 2, 4 and 12 post randomisatio]
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 Outcome Measures
- Sleep Diary [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.
- Actigraphy [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
- Side effects of treatment [Day 7 and 14 post randomisation]
Side effects will be reported using a questionnaire developed for isnomnia tretaments. The questionnaire contains questions e.g. about pain, sleepiness, fatigue, headache
- Treatment Credibility Scale [Day 4 post randomisation]
A five-item version of Credibility/Expectancy Questionnaire, total score ranging from 0-50. Higher scores indicative of higher credibility.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Admitted to the psychiatric inpatient care (Psykiatri Sydväst)
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Depressive symptoms / confirmed depressive episode (uni- or bipolar)
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Reports or is observed to have sleep problems in the form of insomnia, hypersomnia or delayed circadian phase
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Knowledge of Swedish or English that is deemed sufficient to undergo the treatment
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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:
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Dementia
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Intellectual disability
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Severe somatic comorbidity with life expectancy <6 months
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Ongoing mania / mixed-state
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Complex problems that make APS impossible or inappropriate
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Expected discharge within 3 days
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Karolinska Institutet
- Stockholm Region
Investigators
- Principal Investigator: Sandra Tamm, Karolinska Institutet
- Principal Investigator: Susanna Jernelöv, Karolinska Institutet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Dnr 2023-02223-01