Acute Psychological Sleep Stabilisation for Patients Hospitalised With Depression

NCT ID: NCT06145555

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-07
• Study Completion Date: 2027-03-31

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.

Conditions

Insomnia; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Acute psychological sleep stabilization

Intervention Type: BEHAVIORAL

See above (arm description)

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).

Group Type: ACTIVE_COMPARATOR

Sleep hygiene education

Intervention Type: BEHAVIORAL

See above (arm description)

Interventions

Acute psychological sleep stabilization

See above (arm description)

Intervention Type: BEHAVIORAL

Sleep hygiene education

See above (arm description)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Sandra Tamm

M.D., PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra Tamm

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Susanna Jernelöv

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Psykiatri Sydväst, Karolinska Hospital Huddinge

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

Dnr 2023-02223-01

Identifier Type: -

Identifier Source: org_study_id