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

ConditionsSleep Disorder; Insomnia Type Psychiatric Disorders

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorHaukeland University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Group-based cognitive behavioral therapy for insomnia
Behavioral
Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques
Group-based cognitive behavioral therapy for insomnia and additive bb-glasses
Behavioral
Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, bb-glasses worn from 3 hrs before bedtime.
8-week wait list for sleep-school
Other intervention
Treatment as usual in a psychiatric outpatient clinic

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: n=15, Sleep-school 8 weeksExperimental treatment 1 intervention

Group B: n=15, Sleep-school 8 weeks and additive bb-glassesExperimental treatment 2 interventions

Group C: n=30 8-week wait list for sleep-schoolActive comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

baseline, bi-weekly and post intervention after 8 weeks, follow-up after 12 months

Secondary outcomes

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)

Time frame

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.

Time frame

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

Time frame

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.

Time frame

baseline and post intervention after 8 weeks, follow-up after 12 months

Other outcomes

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.

Time frame

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™)

Time frame

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.

Time frame

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.

Time frame

baseline and post intervention after 8 weeks, follow-up after 12 months