Clinical trial NCT04144231: Cognitive Behavioral Therapy for Insomnia (CBT-I) in Schizophrenia(SLEEPINS)
Official title: Cognitive Behavioral Therapy for Insomnia (CBT-I) in Schizophrenia - A Randomized Controlled Clinical Trial (SLEEPINS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Schizophrenia
Schizoaffective Disorder
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: Finnish Institute for Health and Welfare
name: Finnish Institute of Occupational Health
First posted: 2019-10-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

To participate in the study, patients must meet the following criteria:

1. 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.
2. Be currently in psychiatric care at HUS
3. Be 18 years of age or older
4. Have a serious mental disorder (schizophrenia or schizoaffective disorder)
5. Have a stable medical condition
6. Have self-reported sleep problems: difficulty falling asleep, difficulty staying asleep, poor quality of sleep, or dissatisfaction with sleep
7. Have access to an electronic inquiry and treatment program and use of e-mail
8. Be able to participate in a sleep group if randomized.

Exclusion Criteria:

Exclusion criteria include:

1. ongoing cognitive-behavioral psychotherapy
2. diagnosed sleep disorder such as sleep apnea
3. insufficient Finnish language skills (insomnia interventions are produced in Finnish, so good Finnish language skills are required)

Primary outcomes:
measure: Change in Insomnia Severity Index score (ISI) (Morin 2011)
timeFrame: baseline, 12, 24 and 36 weeks from the baseline
measure: Change in the health-related quality of life (HRQoL) instrument 15D score (Sintonen, 2001)
timeFrame: baseline, 12, 24 and 36 weeks from the baseline
Secondary outcomes:
measure: Self-reported subjective sleep quality collected through a digital smartphone app (AIDO Healthcare)
timeFrame: baseline to week 36
measure: Self-reported subjective fatigue collected through a digital smartphone app (AIDO Healthcare)
timeFrame: baseline to week 36
measure: Self-reported subjective mood collected through a digital smartphone app (AIDO Healthcare)
timeFrame: baseline to week 36
measure: Self-reported variables for sleep quantity and quality (adapted from Partinen 1996)
timeFrame: baseline, 12, 24 and 36 weeks from the baseline
measure: Self-reported variables for chronotype (Horne 1976)
timeFrame: baseline, 12, 24 and 36 weeks from the baseline
measure: Self-reported variables for dreaming and nightmares (adapted from Sandman 2015)
timeFrame: baseline, 12, 24 and 36 weeks from the baseline
measure: Self-reported variables for tiredness, fatigue, subjective memory, stress and recovery (Lundqvist 2016)
timeFrame: baseline, 12, 24 and 36 weeks from the baseline
measure: Self-reported variables for functional ability (adapted from Tuomi 1998).
timeFrame: baseline, 12, 24 and 36 weeks from the baseline
measure: Self-reported variables for symptoms of depression (Korenke 2001)
timeFrame: baseline, 12, 24 and 36 weeks from the baseline
measure: Self-reported variables for symptoms of psychosis (adapted from Haddoc 1999),
timeFrame: baseline, 12, 24 and 36 weeks from the baseline
measure: Self-reported variables for lifestyle
timeFrame: baseline, 12, 24 and 36 weeks from the baseline
measure: Subjective measures of Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) (Morin 2007)
timeFrame: baseline, 12, 24 and 36 weeks from the baseline
measure: Self-reported Feedback Questionnaire
timeFrame: 12 weeks
measure: Objective information on sleep from Actigraphy (ACG) data
timeFrame: baseline (1 week) and week 12(1 week)
measure: Objective information on circadian rhythms from Actigraphy (ACG) data
timeFrame: baseline (1 week) and week 12(1 week)
measure: Subjective sleep diary tracking
timeFrame: baseline (1 week) and week 12(1 week)
measure: Objective information on activity from EMFIT Sleep Tracker data (Emfit Ltd)
timeFrame: baseline to week 13
measure: Objective information on recovery of the autonomic nervous system from EMFIT Sleep Tracker data (Emfit Ltd)
timeFrame: baseline to week 13
measure: Cognitive performance is measure with the psychomotor vigilance test (PVT) (Basner 2011) via a web-based interface
timeFrame: baseline, 12, 24 and 36 weeks from the baseline
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Tiina M. Paunio, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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