Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID04463498

Sleep in Psychiatric Care: A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia

Led by Haukeland University Hospital · Updated on 2024-06-18

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

H

Haukeland University Hospital

Lead Sponsor

U

University of Bergen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Sleep disorders, particularly insomnia, often occur alongside psychiatric conditions. Researchers are studying the effects of a non-drug, group-based treatment called cognitive behavioral therapy for insomnia (CBTi) on sleep and psychiatric symptoms. They aim to fill the knowledge gap about how to best treat sleep problems within psychiatric care. CBTi includes sleep education, restricting time in bed, controlling stimuli related to sleep, and changing unhelpful thoughts about sleep. Participants are randomized into one of three groups: one receiving usual psychiatric care plus group-based CBTi, another receiving the same plus wearing blue-blocking glasses before bedtime, and a third group placed on an 8-week waitlist continuing usual care. The group sessions occur every other Monday for about two hours. All participants have an initial consultation including eligibility assessment, diagnostic evaluation, and sleep hygiene education. Follow-up occurs 12 months after treatment. Throughout the study, participants undergo assessments of insomnia symptoms at baseline, bi-weekly during treatment, after 8 weeks, and at 12 months follow-up. Researchers measure various sleep parameters such as time in bed, sleep efficiency, total sleep time, and early morning awakening. They also monitor changes in depression, anxiety, fatigue, work status, and general well-being. Treatment adherence and safety are observed as part of the study.

CONDITIONS

Brief Title

Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients referred to the sleep-school at Bjørgvin DPS psychiatric hospital
  • Patients meeting DSM-V criteria for insomnia with moderate to severe psychiatric illness
  • Confirmed F-diagnosis based on ICD-11 and/or insomnia with scores ≥19 on BDI and/or scores ≥16 on BAI at referral
Not Eligible

You will not qualify if you...

  • Working night shifts
  • Patients not meeting DSM-V criteria for insomnia with moderate to severe psychiatric illness
  • Not meeting confirmed F-diagnosis based on ICD-10 and/or insomnia with scores ≥19 on BDI and/or scores ≥16 on BAI at referral

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for individual consultation including eligibility assessment and education on sleep regulation and sleep hygiene

Treatment

Duration - 8 weeks

Participants join an 8-week group-based cognitive behavioral therapy for insomnia (CBTi) program, either with or without additional use of blue-blocking glasses. Those on the waitlist continue treatment as usual in the psychiatric outpatient clinic during this period.

Group meetings every other Monday from noon until 2 pm

Follow-up

Duration - 12 months

Participants are followed up 12 months after the treatment or waitlist period to assess long-term outcomes.

1 follow-up visit

Trial Site Locations

Total: 1 location

1

Haukeland University Hospital

Bergen, Norway, 5113

Actively Recruiting

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Research Team

A

Ane Wilhelmsen-Langeland, PhD

B

Berge Osnes, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial.

Ane Wilhelmsen-Langeland, Ingvild West Saxvig, Michael Gradisar...

https://pubmed.ncbi.nlm.nih.gov/40250874