Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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).

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

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)

Study details
    Insomnia
    Schizophrenia
    Schizoaffective Disorder

NCT04144231

Helsinki University Central Hospital

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.