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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute psychological sleep stabilization | Experimental | 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). |
|
| Sleep hygiene education | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute psychological sleep stabilization | Behavioral | See above (arm description) |
|
| 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) |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Tamm | Karolinska Institutet | Principal Investigator |
| Susanna Jernelöv | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psykiatri Sydväst, Karolinska Hospital Huddinge | Stockholm | Sweden |
Individual data will not be shared
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Sleep hygiene education | Behavioral | See above (arm description) |
|
| 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 |
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 |
| 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 |
| 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 |
| D001523 |
| Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |