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

Psychiatric Disorders Clinical Trial

— SIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04463498
• Other study ID #: 66304
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Haukeland University Hospital
• Contact: Ane Wilhelmsen-Langeland, PhD
• Phone: +47 55957000
• Email: ane.wilhelmsen-langeland[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mental Disorders
• Parasomnias
• Problem Behavior
• Psychiatric Disorders
• Sleep Disorder; Insomnia Type
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Behavioral:
• Group-based cognitive behavioral therapy for insomnia
Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques
• 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:
• 8-week wait list for sleep-school
Treatment as usual in a psychiatric outpatient clinic

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Insomnia symptoms	Measured by the questionnaires Insomnia severity Index (ISI) and Bergen Insomnia Scale (BIS). From sleep diaries; SOL, WASO and SE.	baseline and post intervention after 8 weeks, follow-up after 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in Sleep onset latency (SOL)	Measured by sleep diary; time in minutes from bed-time to estimated sleep onset	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Secondary	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
Secondary	Changes in Wake after sleep onset (WASO)	Measured by sleep diary; minutes awake after sleep onset	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Secondary	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
Secondary	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
Secondary	Changes in Sleep efficiency (SE)	Measured by sleep diary; total sleep time/time in bed x 100= percentage SE	baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in Heart rate variability (HRV)	24 -hour HRV.	baseline and post intervention after 8 weeks, follow-up after 12 months
Secondary	Work status	Status of employment/unemployment, percentage disability benefits received	baseline and post intervention after 8 weeks, and at follow-up after 12 months