Sleep in Psychiatric Care (SIP): Treatment for Comorbid Delayed Sleep-Wake Phase Disorder (DSWPD)

NCT05177055 | Recruiting

• 1 other identifier: 66304-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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 recommended treatment for Delayed Sleep-Wake phase disorder is light therapy at gradually advanced timing and/or melatonin administered in order to help phase-advance the circadian rhythm. There is a great gap in the knowledge on how sleep disorders can be treated effectively when they occur comorbid to moderate and severe psychiatric illness. In this project the we therefore seek to investigate the effect of psychological and behavioural, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures.

Conditions

Delayed Sleep-Wake Phase Disorder; Sleep Disorder; Psychiatric Disorder

Keywords

Sleep disorders; Delayed sleep-wake phase disorder; blue-blocking glasses; psychiatric disorders; group-based treatment for circadian rhythm sleep disorder

Outcome Measures

Primary Outcomes (1)

• Changes (advancement) of sleep timing

  Measured by sleep diaries, Genactiv actigraphy and saliva samples (intraindividual variation of rise time (IIV), dim light melatonin onset (DLMO), rise /wake up time)

  baseline, post intervention after 6 weeks, follow-up after 12 months

Secondary Outcomes (24)

• Changes in objective sleep onset latency (SOL)

  baseline and post intervention after 6 weeks, follow-up after 12 months

• Changes in Sleep efficiency (SE)

  baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months

• Changes in Time in bed (TIB)

  baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months

• Changes in immediate sleepiness

  baseline, bi-weekly assesment and post intervention after 6 weeks, follow-up after 12 months

• Changes in objective total sleep length/time asleep (TST)

  baseline and post intervention after 6 weeks, follow-up after 12 months

Other Outcomes (10)

• Changes in degree of experienced pain

  baseline and post intervention after 6 weeks, follow-up after 12 months

• Changes in self reported emotion regulation ability

  baseline and post intervention after 6 weeks, follow-up after 12 months

• Changes in vigilance

  baseline and post intervention after 6 weeks, follow-up after 12 months

Study Arms (3)

n=15, sleep-school 6 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 light therapy at gradually advanced timing for DSWPD

n=15, sleep-school 6 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 light therapy at gradually advanced timing for DSWPD; Behavioral: Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses

n=30 Six-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: 6-week wait list for sleep-school

Interventions

Group-based light therapy at gradually advanced timing for DSWPD BEHAVIORAL

Light therapy at gradually advanced timing, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques

Also known as: Group-LT at gradually advanced timing

n=15, sleep-school 6 weeks; n=15, sleep-school 6 weeks and additive bb-glasses

Group-based light therapy at gradually advanced timing for DSWPD and additive bb-glasses BEHAVIORAL

Light therapy (LT) at gradually advanced timing, bb-glasses 12 hrs after LT, Sleep education, sleep hygiene, cognitive restructuring, relaxation techniques

Also known as: Group-LT at gradually advanced timing & bb-glasses

n=15, sleep-school 6 weeks and additive bb-glasses

6-week wait list for sleep-school OTHER

Treatment as usual in a psychiatric outpatient clinic

Also known as: Treatment as usual (TAU)

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

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 DSWPD 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 DSWPD 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:

• Night work
• Patients that do not fulfil the DSM-V criteria for DSWPD 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 (2)

Haukeland University Hospital

Bergen, Tertnes, 5113, Norway

RECRUITING

Haukeland University Hospital

Bergen, 5113, Norway

RECRUITING

Related Publications (1)

• Wilhelmsen-Langeland A, Osnes B, Gradisar M, Vagenes VA, Sorensen L, Bjorvatn B, Fasmer OB, Koenig J, Pallesen S, Saxvig IW. Group bright light therapy compared to treatment as usual for delayed sleep-wake phase disorder among patients in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial. BMJ Open. 2025 Apr 17;15(4):e093091. doi: 10.1136/bmjopen-2024-093091.

  PMID: 40250869 DERIVED

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Sleep Wake Disorders; Mental Disorders

Interventions

Waiting Lists; Therapeutics

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Occupational Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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@helse-bergen.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

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: May 23, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: A description of when the IPD and any additional supporting information will become available and for how long, including the start and end dates or period of availability. This may be provided as an absolute date (for example, starting in January 2025) or as a date relative to the time when summary data are published or otherwise made available (for example, starting 6 months after publication).
• Access Criteria: Not yet decided. PI will be reviewing requests.

Locations

NO (2)