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

NCT04144231 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-10-10

No results posted yet for this 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).

Conditions

Interventions

BEHAVIORAL

iCBT-I

Internet-Based Cognitive Behavioral Therapy for Insomnia (ICBT-I) with the support of a therapist, delivered by mobile application (HUS iCBT-I)

BEHAVIORAL

GCBT-I

Cognitive Behavioral Group Therapy for Insomnia (GCBT-I)

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER
  • Finnish Institute for Health and Welfare

    collaborator OTHER_GOV
  • Finnish Institute of Occupational Health

    collaborator OTHER
  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Tiina M. Paunio, M.D., Ph.D. · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2024-09-06
Completion
2024-09-06

Countries

  • Finland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04144231 on ClinicalTrials.gov