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

NCT ID: NCT05177055

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2027-12-31

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.

Detailed Description

The recommended treatment for Delayed Sleep-Wake phase disorder is bright light therapy (LT) at gradually advanced timing and/or melatonin administered in order to phase-advance the circadian rhythm. Recent research has proven that dark therapy, or blocking light in wavelengths <530 nm by the use of for example orange blue-blocking glasses (bb-glasses), has shown the ability to maintain melatonin production comparable to darkness and to have an advancing effect on the circadian rhythm. The investigators therefore also want to test bb-glasses as an additive treatment to LT at gradually advanced timing.

The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established treatment since 2017. The DSWPD-group gets together every other Monday from 1 pm until 3 pm. The group is open, which means that participants start at different dates and meet people in the group that might be at the end of their treatment, this often leads the group to function as a support for each other. Participants are patients at the general psychiatric outpatient clinic at Bjørgvin DPS in Bergen, Norway. Participants have been referred to the sleep-team by their psychologist or doctor. In this RCT the investigators will carry on the same structure for the group for participants that are recruited to the RCT, hence the project has high ecological validity.

All participants have an individual consultation before joining the group where the focus is on eligibility to participate in the group-based treatment, sleep-diagnostic evaluation, receive a standardized education on sleep-regulation and sleep hygiene advice and receive a date to start the group-based LT at gradually advanced timing. In a randomized manner, they will be allocated to the sleep-school group and start the treatment on the next possible date or to a 6 week wait-list and receive a date the treatment starts. All eligible participants will be informed that there may be a waitlist and receive a start-date without being informed that thay are on a waitlist group or not a waitlist group. All participants will be treated as usual (TAU) for their psychiatric problems parallel to either sleep-school or waitlist, hence both groups are in active treatment for their symptoms. Participants that start sleep-school as soon as possible, are also allocated to a) ordinary group-based LT at gradually advanced timing for 6 weeks or b) group-based group-based LT at gradually advanced timing for 6 weeks and bb-glasses. All participant will be followed up after 12 months.

Conditions

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

Study Design

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

Study Groups

n=15, sleep-school 6 weeks

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.

Group Type: EXPERIMENTAL

Group-based light therapy at gradually advanced timing for DSWPD

Intervention Type: BEHAVIORAL

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

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

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.

Group Type: EXPERIMENTAL

Group-based light therapy at gradually advanced timing for DSWPD

Intervention Type: BEHAVIORAL

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

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

Intervention Type: BEHAVIORAL

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

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

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.

Group Type: ACTIVE_COMPARATOR

6-week wait list for sleep-school

Intervention Type: OTHER

Treatment as usual in a psychiatric outpatient clinic

Interventions

Group-based light therapy at gradually advanced timing for DSWPD

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

Intervention Type: BEHAVIORAL

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

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

Intervention Type: BEHAVIORAL

6-week wait list for sleep-school

Treatment as usual in a psychiatric outpatient clinic

Intervention Type: OTHER

Other Intervention Names

Group-LT at gradually advanced timing; Group-LT at gradually advanced timing & bb-glasses; Treatment as usual (TAU)

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ane Wilhelmsen-Langeland, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Haukeland University Hospital

Bergen, Tertnes, Norway

Site Status: RECRUITING

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Ane Wilhelmsen-Langeland, PhD

Role: CONTACT

ane.wilhelmsen-langeland@helse-bergen.no

+47 55957000 ext. 7192

Berge Osnes, PhD

Role: CONTACT

berge.osnes@helse-bergen.no

+47 55957000

Facility Contacts

Ane Wilhelmsen-Langeland, PhD

Role: primary

ane.wilhelmsen-langeland@helse-bergen.no

+47 92843253

Veronika A Vågenes, BA

Role: backup

veronika.alice.vågenes@helse-bergen.no

+47 90078867

Ane Wilhelmsen-Langeland, PhD

Role: primary

ane.wilhelmsen-langeland@helse-bergen.no

+47 92843253

Berge Osnes, PhD

Role: backup

berge.osnes@uib.no

+47 92445081

References

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.

Reference Type: DERIVED

PMID: 40250869 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

66304-2

Identifier Type: -

Identifier Source: org_study_id