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

NCT04463498 | Recruiting

• 1 other identifier: 66304
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often treated with medication or not at all in psychiatric care, although there exist a plethora of documentation of the effectiveness of sleep interventions. There is also an increase in studies showing effectiveness of sleep-interventions when the sleep disorder co-occurs with psychiatric illness. The most common and best documented treatment for insomnia is cognitive behavioral therapy for insomnia (CBTi). There is a great gap in the knowledge on how sleep disorders can be treated effectively in psychiatric care. In this project the investigators therefore seek to investigate the effect of non-pharmacological, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures. CBTi comprise of sleep education, sleep restriction, stimulus control and cognitive restructuring of dysfunctional thoughts about sleep.

Conditions

Sleep Disorder; Insomnia Type; Psychiatric Disorders

Keywords

sleep disorders; insomnia; psychiatric disorders; bb-glasses; group-based cognitive behavioural therapy for insomnia

Outcome Measures

Primary Outcomes (1)

• Insomnia symptoms

  Measured by the questionnaires Insomnia severity Index (ISI) and Bergen Insomnia Scale (BIS). From sleep diaries; sleep onset latency (SOL), wake after sleep onset (WASO) and sleep efficiency (SE).

  baseline, bi-weekly and post intervention after 8 weeks, follow-up after 12 months

Secondary Outcomes (19)

• Changes in insomnia diagnosis

  baseline and post intervention after 8 weeks, follow-up after 12 months

• Changes in insomnia severity

  baseline and post intervention after 8 weeks, follow-up after 12 months

• Changes in Time in bed (TIB)

  baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months

• Changes in objective early morning awakening (EMA)

  baseline and post intervention after 8 weeks, follow-up after 12 months

• Changes in objective wake after sleep onset (WASO)

  baseline and post intervention after 8 weeks, follow-up after 12 months

Other Outcomes (12)

• Changes in symptoms of inattention

  baseline and post intervention after 8 weeks, follow-up after 12 months

• Changes in vigilance

  baseline and post intervention after 8 weeks, follow-up after 12 months

• Changes in self reported emotion regulation ability

  baseline and post intervention after 8 weeks, follow-up after 12 months

Study Arms (3)

n=15, Sleep-school 8 weeks

EXPERIMENTAL

Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.

Behavioral: Group-based cognitive behavioral therapy for insomnia

n=15, Sleep-school 8 weeks and additive bb-glasses

EXPERIMENTAL

Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school and additive treatment with bb-glasses. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.

Behavioral: Group-based cognitive behavioral therapy for insomnia; Behavioral: Group-based cognitive behavioral therapy for insomnia and additive bb-glasses

n=30 8-week wait list for sleep-school

ACTIVE COMPARATOR

Patients receive treatment as usual in the psychiatric clinic while they wait for participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator.

Other: 8-week wait list for sleep-school

Interventions

Group-based cognitive behavioral therapy for insomnia BEHAVIORAL

Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques

Also known as: Group - CBTi

n=15, Sleep-school 8 weeks; n=15, Sleep-school 8 weeks and additive bb-glasses

8-week wait list for sleep-school OTHER

Treatment as usual in a psychiatric outpatient clinic

Also known as: Treatment as usual

n=30 8-week wait list for sleep-school

Group-based cognitive behavioral therapy for insomnia and additive bb-glasses BEHAVIORAL

Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, bb-glasses worn from 3 hrs before bedtime.

Also known as: Group - CBTi & bb-glasses

n=15, Sleep-school 8 weeks and additive bb-glasses

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to the sleep-school at Bjørgvin DPS psychiatric hospital
• Patients fulfilling the Diagnostic Manual for Mental Disorders (DSM-V) criteria for insomnia comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the International Statistical Classification of Diseases and Related Health Problems (ICD-11) diagnostic system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)

You may not qualify if:

• Nightwork
• Patients that do not fulfil the DSM-V criteria for insomnia comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the ICD-10 diagnostic system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5113, Norway

RECRUITING

Related Publications (1)

• Wilhelmsen-Langeland A, Saxvig IW, Gradisar M, Vagenes VA, Pallesen S, Sorensen L, Fasmer OB, Koenig J, Bjorvatn B, Osnes B. 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. BMJ Open. 2025 Apr 17;15(4):e090997. doi: 10.1136/bmjopen-2024-090997.

  PMID: 40250874 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Mental Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Waiting Lists; Therapeutics

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Ane Wilhelmsen-Langeland, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ane Wilhelmsen-Langeland, PhD

CONTACT

+47 55957000; ane.wilhelmsen-langeland@helse-bergen.no

Berge Osnes, PhD

CONTACT

+47 55957000; berge.osnes@uib.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All eligible participants will be informed that there may be a waitlist (length not specified) and receive a start-date without being informed that thay are in a waitlist group or not a waitlist group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: July 9, 2020
• Study Start: December 17, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: By August 31st 2025
• Access Criteria: Not yet decided. PI will be reviewing requests.

Locations

NO (1)