Sleep problems are pervasive in people with schizophrenia. In our study, our goal is to determine whether we can alleviate sleep symptoms and improve quality of life and well-being in patients with major psychiatric disorders through cognitive behavioral therapy (CBT) delivered via the internet or in groups. At the same time, the study provides information on factors that are commonly associated with sleep and well-being in patients. The intervention study is conducted as a Randomized Controlled Clinical Trial (RCT), in which subjects are randomized into three groups: 1) Treatment as usual (TAU), 2) TAU and Internet-based therapy for insomnia (ICBT-I), and 3) TAU and group therapy for insomnia (GCBT-I).
Sleep is important for well-being. Lack of sleep and poor quality of sleep (Insomnia) are risk factors for psychiatric and somatic diseases such as depression, cardiovascular disease, diabetes and memory disorders and increases the risk of cognitive errors and accidents. Psychiatric patients suffer from a wide variety of sleep disorders. Insomnia symptoms are known to increase the likelihood of later depression and even the use of disability pensions due to depression. Various sleep disorders are also common in patients with schizophrenia. Previous studies on schizophrenia have reported-, symptoms of insomnia, especially the problem of falling asleep and poor sleep quality, circadian rhythm disruption, hypersomnolence and nightmares among the patients. Cognitive behavioural therapy for insomnia (CBT-I) is an evidence-based treatment for insomnia. CBT-I can be implemented as an individual treatment, on a group basis or via the internet. There is evidence that CBT-I can also be used to treat a patient with a major psychiatric disorders, but randomized clinical trials (RCT) have rarely been published. Our research is based on the hypothesis that symptoms of insomnia in patients with schizophrenia can improved by CBT-I and, further, by improving patients' sleep quality their health and quality of life can also be improved. The present study is designed to investigate the effect of two different treatment programs as compared to treatment as usual (TAU). The purpose of this study is to determine whether CBT-I can help relieve sleep symptoms and improve quality of life and well-being in patients with schizophrenia. At the same time, the study provides information on factors that are commonly associated with sleep and well-being in patients with major psychiatric disorders. The intervention study is conducted as an RCT, in which subjects are randomized into three groups: 1) Treatment as usual (TAU), 2) TAU and Internet-based therapy for insomnia (ICBT-I), and 3) TAU and group therapy for insomnia (GCBT-I). The aim of this ongoing randomized controlled trial is to recruit 84 - 120 participants from Hospital District of Helsinki and Uusimaa (HUS) Psychiatry Outpatient Clinics for Psychosis, and they have previously participated in the nationwide SUPER Finland study (a study on genetic mechanisms of psychotic disorders and a part of the Stanley Global Neuropsychiatric Genomics Initiative). The study is performed on a cycle basis with a target of 12 to 24 patients per cycle, randomly assigned to three intervention groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Helsinki University Central Hospital
Helsinki, Uusimaa, Finland
RECRUITINGChange in Insomnia Severity Index score (ISI) (Morin 2011)
A 7-item questionnaire used to assess insomnia severity with a score ranging between 0 to 28. Each questionnaire item addresses an aspect about sleep that is rated by the respondent on a 5-point scale (i.e., 0=no problem to 4=very severe problem).
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Change in the health-related quality of life (HRQoL) instrument 15D score (Sintonen, 2001)
The 15D is a generic, comprehensive, 15-dimensional, standardized, self-administered measure of health-related quality of life (HRQoL) that can be used both as a profile and single index score measure. The maximum score is 1 (no problems on any dimension) and the minimum score is 0 (being dead).
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported subjective sleep quality collected through a digital smartphone app (AIDO Healthcare)
1-2 times a week by emoji scale 1-5
Time frame: baseline to week 36
Self-reported subjective fatigue collected through a digital smartphone app (AIDO Healthcare)
1-2 times a week by emoji scale 1-5
Time frame: baseline to week 36
Self-reported subjective mood collected through a digital smartphone app (AIDO Healthcare)
1-2 times a week by emoji scale 1-5
Time frame: baseline to week 36
Self-reported variables for sleep quantity and quality (adapted from Partinen 1996)
Questions about sleep quantity and quality
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for chronotype (Horne 1976)
Questions about chronotype (morningness-eveningness-)
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for dreaming and nightmares (adapted from Sandman 2015)
Questions about dreaming and nightmares
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for tiredness, fatigue, subjective memory, stress and recovery (Lundqvist 2016)
Questions about tiredness, fatigue, subjective memory, stress and recovery. Scale 1(very good) to 5(very poor).
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for functional ability (adapted from Tuomi 1998).
Questions about functional ability. Scale 0(very poor) to 10(very good).
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for symptoms of depression (Korenke 2001)
Questions about symptoms of depression. Scale 0(not at all) to 3 (Almost Always)
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for symptoms of psychosis (adapted from Haddoc 1999),
Questions about presence, severity, and characteristics of hallucinations, delusions, confused and disturbed thoughts and lack of insight and self-awareness.
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for lifestyle
Questions about exercise, usage of caffeine, alcohol, nicotine.
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Subjective measures of Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) (Morin 2007)
DBAS-16 is a 16-item self reported questionnaire to measure people's beliefs and attitudes about their personal sleep situations. Items are ranked from 0, strongly disagree, to 10, strongly agree. Total score is mean of all questions, with a higher score representing more dysfunctional beliefs and attitude about sleep.
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported Feedback Questionnaire
Participants experiences from the intervention including habits of practice of the new skills, experience of the effect of the intervention on sleep, mood and lifestyle, alliance with the therapist, the positive and negative effects of the treatment are questioned after the treatment period.
Time frame: 12 weeks
Objective information on sleep from Actigraphy (ACG) data
The dataset from ACG includes Total Sleep Time (TST), Wake After Sleep Onset (WASO) Bed time, Get up time, Time in bed, Sleep efficiency (SE), Sleep Onset Latency (SOL), One minute immobility and Fragmentation index
Time frame: baseline (1 week) and week 12(1 week)
Objective information on circadian rhythms from Actigraphy (ACG) data
The dataset from ACG includes Cosine peak, Light/Dark ratio, Lowest 5 onset, Maximum 10 onset, RA, IV and IS
Time frame: baseline (1 week) and week 12(1 week)
Subjective sleep diary tracking
Each morning after waking participants completed the Sleep Diary during the ACG -monitoring period to provide a daily record of self-reported bedtime, get-up time, sleep duration, and daytime naps.
Time frame: baseline (1 week) and week 12(1 week)
Objective information on activity from EMFIT Sleep Tracker data (Emfit Ltd)
EMFIT device measures heart rate, breathing rate, movement activity every 4 seconds, sleep staging every 30 seconds, and heart rate variability every 3 minutes.
Time frame: baseline to week 13
Objective information on recovery of the autonomic nervous system from EMFIT Sleep Tracker data (Emfit Ltd)
EMFIT device measures heart rate, breathing rate, movement activity every 4 seconds, sleep staging every 30 seconds, and heart rate variability every 3 minutes.
Time frame: baseline to week 13
Cognitive performance is measure with the psychomotor vigilance test (PVT) (Basner 2011) via a web-based interface
PVT is a sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus
Time frame: baseline, 12, 24 and 36 weeks from the baseline
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