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

Not Applicable

Recruiting

• Conditions: Psychiatric Disorders; Sleep Disorder; Insomnia Type
• Interventions: Behavioral: Group-based cognitive behavioral therapy for insomnia; Other: 8-week wait list for sleep-school; Behavioral: Group-based cognitive behavioral therapy for insomnia and additive bb-glasses

• Registration Number: NCT04463498
• Lead Sponsor: Haukeland University Hospital

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.

Detailed Description

The recommended treatment for insomnia is CBTi. 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 additive effect in the treatment of insomnia. The investigators therefore also want to test bb-glasses as an additive treatment to CBTi for insomnia.

The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established treatment since 2017. The insomnia-group gets together every other Monday from noon until 2 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 CBTi treatment. Participants are patients at the general psychiatric outpatient clinic at Bjørgvin DPS. Participant 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.

All participants have an individual consultation before joining the group where the focus is on eligibility to participate in the group-based treatment, diagnostic evaluation, receive a standardized education on sleep-regulation and sleep hygiene advice and receive a date to start the group-based CBTi treatment. 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 8 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 in 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. Participants that start sleep-school as soon as possible, are also allocated to a) ordinary group-based CBTi 8 weeks or b) group-based CBTi 8 weeks and bb-glasses. All participant will be followed up after 12 months.

Study Timeline

• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-09
• Study Start: 2021-12-17
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 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)

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
n=15, Sleep-school 8 weeks and additive bb-glasses	Group-based cognitive behavioral therapy for insomnia	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.
n=15, Sleep-school 8 weeks	Group-based cognitive behavioral therapy for insomnia	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.
n=30 8-week wait list for sleep-school	8-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.
n=15, Sleep-school 8 weeks and additive bb-glasses	Group-based cognitive behavioral therapy for insomnia 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.

Primary Outcome Measures

Name	Time	Method
Insomnia symptoms	baseline, bi-weekly and post intervention after 8 weeks, follow-up after 12 months	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).

Secondary Outcome Measures

Name	Time	Method
Changes in objective wake after sleep onset (WASO)	baseline and post intervention after 8 weeks, follow-up after 12 months	Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of average minutes awake after sleep onset.
Changes in Daytime function (DF)	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months	Measured by sleep diary; subjective assesment of daytime function on a scale from 1=very good to 5=very poor
Changes in objective sleep onset latency (SOL)	baseline and post intervention after 8 weeks, follow-up after 12 months	Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of minutes of average sleep onset latency.
Changes in fatigue	baseline and post intervention after 8 weeks, and at follow-up after 12 months	Measured by Chalder fatigue Scale (CFQ). The higher the score, the more fatigued
Changes in insomnia severity	baseline and post intervention after 8 weeks, follow-up after 12 months	Measured by the Insomnia Severity Index (ISI). The ISI is a 7-item scale assessing the perceived severity of insomnia symptoms (initial, middle, terminal), the degree of satisfaction with sleep, interference with daytime functioning, noticeability of impairment, and concern caused by the sleep problems. The scale is Likert-type with 5 anchor points ranging from 0 to 4. The scale ranges from 0 to 28 and the higher the score, the more severe insomnia. The usual time frame for responding is the last 2 weeks.
Changes in objective total sleep length/time asleep (TST),	baseline and post intervention after 8 weeks, follow-up after 12 months	Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number in minutes of average total sleep time.
Changes in Total sleep length/time asleep (TST)	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months	Measured by sleep diary: Time in bed minus time awake
Changes in Sleep quality (SQ)	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months	Measured by sleep diary; subjective assesment of sleep quality on a scale from 1=very light to 5=very deep
Changes in beliefs and attitudes about sleep	baseline and post intervention after 8 weeks, follow-up after 12 months	Measured by Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16). The DBAS-16 measures the degree of dysfunctional beliefs about sleep with 16 items. It has 4 subscales (1) sleep-related worry and helplessness; 2) beliefs about sleep medications; 3) expectations about sleep need; and 4) beliefs about the consequences/effects of insomnia and 1 total scale score. The higher the score, the more dysfunctional beliefs about sleep.
Changes in Time in bed (TIB)	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months	Measured by sleep diary; time from bed-time to rise time
Changes in objective early morning awakening (EMA)	baseline and post intervention after 8 weeks, follow-up after 12 months	Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of average minutes early morning awakening.
Changes in anxiety	baseline and post intervention after 8 weeks, follow-up after 12 months	Measured by Becks Anxiety Inventory (BAI). The higher the score, the more symptoms of anxiety
Work status	baseline and post intervention after 8 weeks, and at follow-up after 12 months	Status of employment/unemployment, percentage disability benefits received. Measured by Work and social adjustment scale (WSAS) and self-report.
Changes in insomnia diagnosis	baseline and post intervention after 8 weeks, follow-up after 12 months	Measured by the Bergen Bergen Insomnia Scale (BIS). The BIS measure subjective symptoms of insomnia during the previous week and give a total score (minimum 0, maximum 42; the higher the score, the worse severity of insomnia) and a clinical incidence of insomnia diagnosis-score (yes/no)
Well-being	baseline and post intervention after 8 weeks, and at follow-up after 12 months	Measured by World Health Organization well-being scale (WHO-5). The higher the score, the higher well-being.
Changes in Early morning awakening (EMA)	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months	Measured by sleep diary; minutes awake before rise time
Changes in objective time in bed (TIB)	baseline and post intervention after 8 weeks, follow-up after 12 months	Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number in minutes of average time in bed.
Changes in objective sleep efficiency (SE)	baseline and post intervention after 8 weeks, follow-up after 12 months	Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number from 0-100% that gives average sleep efficiency.
Changes in depression	baseline and post intervention after 8 weeks, follow-up after 12 months	Measured by Becks Depression Inventory -II (BDI-II). The higher the score, the more symptoms of depression

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway