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

Last updated: October 5, 2023
Sponsor: Helsinki University Central Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Schizophrenia And Schizoaffective Disorders (Pediatric)

Tourette's Syndrome

Treatment

GCBT-I

iCBT-I

Clinical Study ID

NCT04144231
1129003, TYH2018219, 30000
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 partof 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 stayingasleep, 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

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)

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: GCBT-I
Phase:
Study Start date:
December 19, 2019
Estimated Completion Date:
September 06, 2024

Study 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.

Connect with a study center

  • Helsinki University Central Hospital

    Helsinki, Uusimaa 00290
    Finland

    Active - Recruiting

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