Clinical trial NCT06145555: Acute Psychological Sleep Stabilisation for Patients Hospitalised with Depression
Official title: Acute Psychological Sleep Stabilisation for Patients Hospitalised with Depression
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Insomnia
Depression
Keywords: CBT
Psychiatry
Inpatient care
Sleep
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2023-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: 2 weeks post randomization (secondary timepoints include day 4, 7, 10 and week 4 and 12)
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Day 4, 7, 10 14 and week 4 and 12 post randomisation
measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Day 4, 7, 10 14 and week 4 and 12 post randomisation
measure: European Quality of Life 5 Dimensions scale (EQ-5D)
timeFrame: Week 2, 4 and 12 post randomisation
Other outcomes:
measure: Sleep Diary
timeFrame: 0-14 days post randomisation
measure: Actigraphy
timeFrame: 0-14 days post randomisation
measure: Side effects of treatment
timeFrame: Day 7 and 14 post randomisation
measure: Treatment Credibility Scale
timeFrame: Day 4 post randomisation
Locations:
city: Stockholm
country: Sweden
facility: Psykiatri Sydväst, Karolinska Hospital Huddinge
Study officials:
affiliation: Karolinska Institutet
name: Sandra Tamm
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Susanna Jernelöv
role: PRINCIPAL_INVESTIGATOR
References: