Haukeland University Hospital
Bergen, 5113, Norway
Location status: Recruiting
Location contact
Ane Wilhelmsen-Langeland, PhD
CONTACT
Berge Osnes, PhD
CONTACT
NCT Number: NCT04463498
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Bergen, 5113, Norway
Location status: Recruiting
Ane Wilhelmsen-Langeland, PhD
CONTACT
Berge Osnes, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques
Other names: Group - CBTi
Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, bb-glasses worn from 3 hrs before bedtime.
Other names: Group - CBTi & bb-glasses
Treatment as usual in a psychiatric outpatient clinic
Other names: Treatment as usual
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Measured by sleep diary; minutes awake before rise time
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
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.
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Measured by the Conners Continuous Performance (CPT) Test 3rd Edition™ (Conners CPT 3™)
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
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.
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Measured by a visual analogue scale (VAS Pain) ranging from 0 to 10. The higher the score, the worse the pain.
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
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.
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
We will measure self-reported executive functions using the Behaviour Rating Inventory for Executive Functions Self-Report (BRIEF- SR)
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
We will measure systolic and diastolic pressure by a digital blood pressure measurement machine.
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
24 -hour HRV.
Time frame: post intervention after 8 weeks
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.
Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
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.
Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
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.
Time frame: baseline and post intervention after 8 weeks, and at follow-up after 12 months
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)
Contact information is provided by the study sponsor or research team.
Ane Wilhelmsen-Langeland, PhD
CONTACT
Berge Osnes, PhD
CONTACT
Haukeland University Hospital
Other
Sleep in Psychiatric Care: A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia
Acronym: SIP
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