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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ane Wilhelmsen-Langeland, PhD; Phone Number: +47 55957000; Email: ane.wilhelmsen-langeland@helse-bergen.no
• Study Contact Backup: Name: Berge Osnes, PhD; Phone Number: +47 55957000; Email: berge.osnes@uib.no

Study Locations

• Norway
  • Bergen, Norway, 5113
    • Recruiting
    • Haukeland University Hospital
    • Contact: Ane Wilhelmsen-Langeland, PhD; Phone Number: +47 92843253; Email: ane.wilhelmsen-langeland@helse-bergen.no
    • Contact: Berge Osnes, PhD; Phone Number: +47 92445081; Email: berge.osnes@uib.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: n=15, Sleep-school 8 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.	Behavioral: Group-based cognitive behavioral therapy for insomnia; Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques; Other Names: Group - CBTi
Experimental: n=15, Sleep-school 8 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.	Behavioral: Group-based cognitive behavioral therapy for insomnia; Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques; Other Names: Group - CBTi; Behavioral: Group-based cognitive behavioral therapy for insomnia and additive bb-glasses; Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, bb-glasses worn from 3 hrs before bedtime.; Other Names: Group - CBTi & bb-glasses
Active Comparator: n=30 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.	Other: 8-week wait list for sleep-school; Treatment as usual in a psychiatric outpatient clinic; Other Names: Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in insomnia diagnosis	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)	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in insomnia severity	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.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in Time in bed (TIB)	Measured by sleep diary; time from bed-time to rise time	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in objective early morning awakening (EMA)	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.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in objective wake after sleep onset (WASO)	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.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in Early morning awakening (EMA)	Measured by sleep diary; minutes awake before rise time	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in objective time in bed (TIB)	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.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in objective sleep efficiency (SE)	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.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in objective total sleep length/time asleep (TST),	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.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in Total sleep length/time asleep (TST)	Measured by sleep diary: Time in bed minus time awake	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in Sleep quality (SQ)	Measured by sleep diary; subjective assesment of sleep quality on a scale from 1=very light to 5=very deep	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in Daytime function (DF)	Measured by sleep diary; subjective assesment of daytime function on a scale from 1=very good to 5=very poor	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in objective sleep onset latency (SOL)	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.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in beliefs and attitudes about sleep	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.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in depression	Measured by Becks Depression Inventory -II (BDI-II). The higher the score, the more symptoms of depression	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in anxiety	Measured by Becks Anxiety Inventory (BAI). The higher the score, the more symptoms of anxiety	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in fatigue	Measured by Chalder fatigue Scale (CFQ). The higher the score, the more fatigued	baseline and post intervention after 8 weeks, and at follow-up after 12 months
Work status	Status of employment/unemployment, percentage disability benefits received. Measured by Work and social adjustment scale (WSAS) and self-report.	baseline and post intervention after 8 weeks, and at follow-up after 12 months
Well-being	Measured by World Health Organization well-being scale (WHO-5). The higher the score, the higher well-being.	baseline and post intervention after 8 weeks, and at follow-up after 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction	Measured by the Client Satisfaction Questionnaire (CSQ8). The CSQ-8 is an 8-item questionnaire that measures patient satisfaction with health services, where the items are rated from 1 (very low satisfaction) to 4 (very high satisfaction). The total score ranges from 8 to 32, with higher scores indicating higher degrees of satisfaction.	post intervention after 8 weeks
Changes in blood pressure	We will measure systolic and diastolic pressure by a digital blood pressure measurement machine.	baseline and post intervention after 8 weeks, follow-up after 12 months
Suicide attempts and admittances in psychiatric wards	Whether or not suicide has been attempted, if applicable number og attempts and whether or nor the patient has been admitted to a psychitaric ward (voluntary/forced)	baseline and post intervention after 8 weeks, and at follow-up after 12 months
Changes in immediate sleepiness	Measured by the Karolinska Sleepiness Scale (KSS). The KSS measure subjective sleepiness at a specific time point (noon). The scale gives a number from 1-9 where 9 indicates "trouble staying awake" and is the worst outcome.	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in sleepiness	Measured by the Epworth Sleepiness Scale (ESS). The ESS is an 8-item scale where the respondent grades the likelihood of falling asleep or dozing off in different daily situations. The responses are graded on a 4-point likert scale 0=no likelihodd to 3=very likely. A score of 11 or higher is considered an indication of excessive daytime sleepiness.	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in Heart rate variability (HRV)	24 -hour HRV.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in degree of experienced pain	Measured by a visual analogue scale (VAS Pain) ranging from 0 to 10. The higher the score, the worse the pain.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in self reported emotion regulation ability	Measured by Difficulties in Emotion Regulation Scale (DERS) which is a 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores suggest greater problems with emotion regulation.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in vigilance	Measured by the Conners Continuous Performance (CPT) Test 3rd Edition™ (Conners CPT 3™)	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in symptoms of inattention	Measured by the Adult attention deficit hyperactivity disorder (ADHD) Self-Rating Scale (ASRS). The scale contains the 18 symptoms of inattention, hyperactivity, and impulsivity defining ADHD according to the DSM-IV-TR and DSM-5. The severity of the symptoms are reported on a 5-point Likert-type scale (0-4 = never, rarely, sometimes, often, to very often), with a total range of 0-72. The higher the score, the more symptoms of inattention.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in symptoms of hypochondria	Measured by the The Whiteley Index (WI). The 14-item WI measures assess health anxiety on a likert-scale from 1="not at all" to "5=very much". The higher the score, the more severe health anxiety.	baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in executive functions	We will measure self-reported executive functions using the Behaviour Rating Inventory for Executive Functions Self-Report (BRIEF- SR)	baseline and post intervention after 8 weeks, follow-up after 12 months

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen
• Investigators: Principal Investigator: Ane Wilhelmsen-Langeland, PhD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: insomnia; sleep disorders; psychiatric disorders; bb-glasses; group-based cognitive behavioural therapy for insomnia
• Additional Relevant MeSH Terms: Behavioral Symptoms; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Problem Behavior; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Mental Disorders; Parasomnias; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: 66304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The investigators plan to share the following individual participant data (IPD); Study protocol and Informed Consent Form (ICF)

IPD Sharing Time Frame Definition: 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).

Limit: 1000 characters.

IPD Sharing Access Criteria Definition: Describe by what access criteria IPD and any additional supporting information will be shared, including with whom, for what types of analyses, and by what mechanism. Information about who will review requests and criteria for reviewing requests may also be provided.

• IPD Sharing Time Frame: By August 31st 2025
• IPD Sharing Access Criteria: Not yet decided. PI will be reviewing requests.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No