Cognitive Behavioral Therapy for Insomnia (CBT-I) in Schizophrenia(SLEEPINS)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Cognitive Behavioral Therapy for Insomnia (CBT-I) in Schizophrenia - A Randomized Controlled Clinical Trial (SLEEPINS)

Conditions
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Insomnia, Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Behavioral: iCBT-I
* Behavioral: GCBT-I


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To participate in the study, patients must meet the following criteria: Have previously participated in the nationwide SUPER Finland study (www.superfinland.fi, a study on genetic mechanisms of psychotic disorders and a part of the Stanley Global Initiative) and have given permission for subsequent contact. Be currently in psychiatric care at HUS Be 18 years of age or older Have a serious mental disorder (schizophrenia or schizoaffective disorder) Have a stable medical condition Have self-reported sleep problems: difficulty falling asleep, difficulty staying asleep, poor quality of sleep, or dissatisfaction with sleep Have access to an electronic inquiry and treatment program and use of e-mail Be able to participate in a sleep group if randomized. Exclusion Criteria: Exclusion criteria include: ongoing cognitive-behavioral psychotherapy diagnosed sleep disorder such as sleep apnea insufficient Finnish language skills (insomnia interventions are produced in Finnish, so good Finnish language skills are required)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment-as-usual (TAU)<br>Treatment-as-usual (TAU) delivered by psychiatrists and psychiatric nurses in HUS Psychiatry Outpatient Clinic for Psychosis. Participants who randomized to TAU -group, may receive medication for insomnia, but they will not received CBT-I. Treatment-as-usual is included in all intervention groups. | |
| Experimental: Internet-Based Cognitive Behavioral Therapy for Insomnia<br>TAU and Internet-Based Cognitive Behavioral Therapy for Insomnia (iCBT-I) with the support of a therapist, delivered by mobile application (HUS iCBT-I): There will be seven manualized sessions, conducted at intervals of either every one or two weeks. HUS iCBT-I, is based on the same theoretical model of insomnia as described in Morin 2003 and Edinger 2015- and involves the same interventions as ordinary CBT-I: a structured treatment focusing on education, behaviors and cognitions. iCBT-I consists of psychoeducation about sleep, sleep restriction therapy, stimulus control, relaxation techniques, and challenging beliefs and perception of sleep. During the therapy, the therapist monitors progress at least once a week, sends messages to the participant, and answers any treatment-related questions. The aim of the feedback is to comment on exercises, clarify intervention and motivate the patient to persist the in carrying out the treatment and the requested behavioral changes. | Behavioral: iCBT-I<br>* Internet-Based Cognitive Behavioral Therapy for Insomnia (ICBT-I) with the support of a therapist, delivered by mobile application (HUS iCBT-I)<br>|
| Experimental: Cognitive Behavioral Group Therapy for Insomnia<br>TAU and Cognitive Behavioral Group Therapy for Insomnia (GCBT-I): There will be six 90-minute manualized sessions, conducted at intervals of either one or two weeks. One booster session will be conducted one month after the treatment. Each group will have 4-8 people. The content of the CBT-I group is based on CBT for insomnia (as described above) and a previously published insomnia treatment manual for psychotic patients (Waters 2017).To ensuring the rights, safety and wellbeing of participants during the COVID-19 (Coronavirus) pandemic, we produce GCBT-I via internet. | Behavioral: GCBT-I<br>* Cognitive Behavioral Group Therapy for Insomnia (GCBT-I)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change 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). | 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). | baseline, 12, 24 and 36 weeks from the baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported subjective sleep quality collected through a digital smartphone app (AIDO Healthcare) | 1-2 times a week by emoji scale 1-5 | 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 | 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 | baseline to week 36 | 
| Self-reported variables for sleep quantity and quality (adapted from Partinen 1996) | Questions about sleep quantity and quality | baseline, 12, 24 and 36 weeks from the baseline | 
| Self-reported variables for chronotype (Horne 1976) | Questions about chronotype (morningness-eveningness-) | 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 | 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). | 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). | 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) | 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. | baseline, 12, 24 and 36 weeks from the baseline | 
| Self-reported variables for lifestyle | Questions about exercise, usage of caffeine, alcohol, nicotine. | 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. | 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. | 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 | 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 | 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. | 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. | 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. | 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 | baseline, 12, 24 and 36 weeks from the baseline |