NCT04290650

Brief Summary

Sleep disturbance is recognized as a major problem for patients with psychosis and is seen in nearly all patients admitted in acute crisis to a psychiatric hospital. Cognitive behavioral treatment is recommended as first-line treatment for insomnia in national and international guidelines. This study explores effect of adapting the milieu therapy to comply with the principles of CBT for insomnia. Our aim is to rethink our day to day psychological interventions and our around the clock milieu therapy for patients with acute and severe mental illness in light of established knowledge on how sleep is obtained and maintained.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

10 months

First QC Date

February 24, 2020

Last Update Submit

June 24, 2021

Conditions

Sleep DisturbancePsychotic Disorders

Keywords

Sleep DisturbancePsychotic Disorders

Outcome Measures

Primary Outcomes (1)

  • Assessment of sleep

    Nursing staff report hours of sleep and number of awakening based on their observations which are recorded in the clinical record by night staff. All patients who receive treatment will be offered the opportunity to keep a sleeping diary for psycheducative purposes. The patients who are able to, will fill out the Insomnia Severity Index which is a brief instrument for assessment of sleep disturbances. In addition all patients, except those who cannot wear one for security reasons, will be offered an actigraph which provides the patient with a clear picture of their sleeping pattern. Relevant data from these actigraphs will be noted in the patients' clinical records.

    10 months

Secondary Outcomes (12)

  • Psychotic symptoms

    10 months

  • Mania symptoms

    10 months

  • Depressive symptoms

    10 months

  • Psychosocial functioning

    10 months

  • Brøset Violence Checklist (BVC)

    10 months

  • +7 more secondary outcomes

Other Outcomes (4)

  • Diagnosis

    10 months

  • Age

    10 months

  • Sex

    10 months

  • +1 more other outcomes

Study Arms (2)

Modified CBT for insomnia

OTHER

All patients admitted to one of the psychosis ward will be offered the same customized treatment focusing on sleep in addition to treatment as usual.

Behavioral: Modified CBT for insomnia

Treatment as usual

OTHER

All patients admitted to the other two psychosis wards will only receive treatment as usual.

Behavioral: Treatment as usual

Interventions

Modified CBT for insomniaBEHAVIORAL

Nurses who are working closely with the patients around the clock will perform an adjusted and modified version of CBT for sleep disturbances, in addition to standard evidence based treatment for psychosis and affective disorders as per today.

Modified CBT for insomnia
Treatment as usualBEHAVIORAL

All patients on the two other psychosis wards will receive standard evidence based treatment for psychosis and affective disorders as per today.

Treatment as usual

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted to th he Acute Psychiatric Department at Oslo University who are able to consent

You may not qualify if:

  • Patients not able to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

ParasomniasPsychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Ingrid Dieset, MD/PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 24, 2020

First Posted

March 2, 2020

Study Start

September 1, 2020

Primary Completion

June 30, 2021

Study Completion

December 31, 2025

Last Updated

June 28, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)