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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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⁃ 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.

Locations
Other Locations
Finland
Helsinki University Central Hospital
RECRUITING
Helsinki
Contact Information
Primary
Tiina M. Paunio, M.D., Ph.D.
tiina.paunio@helsinki.fi
+358503507936
Backup
Tuula E. Tanskanen, RN, MHC
tuula.tanskanen@hus.fi
+358401286262
Time Frame
Start Date: 2019-12-19
Estimated Completion Date: 2024-09-06
Participants
Target number of participants: 120
Treatments
No_intervention: Treatment-as-usual (TAU)
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
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.
Experimental: Cognitive Behavioral Group Therapy for Insomnia
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.
Related Therapeutic Areas
Sponsors
Collaborators: Finnish Institute of Occupational Health, Finnish Institute for Health and Welfare, University of Helsinki
Leads: Helsinki University Central Hospital

This content was sourced from clinicaltrials.gov