Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    schizophrenia | CBT-I
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144231
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : May 24, 2021
Sponsor:
Collaborators:
University of Helsinki
Finnish Institute for Health and Welfare
Finnish Institute of Occupational Health
Information provided by (Responsible Party):
Tiina M. Paunio, Helsinki University Central Hospital

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).


Condition or disease Intervention/treatment Phase
Insomnia Schizophrenia Schizoaffective Disorder Behavioral: iCBT-I Behavioral: GCBT-I Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Insomnia (CBT-I) in Schizophrenia - A Randomized Controlled Clinical Trial (SLEEPINS)
Actual Study Start Date : December 19, 2019
Estimated Primary Completion Date : September 6, 2024
Estimated Study Completion Date : September 6, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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.

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)

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.
Behavioral: GCBT-I
Cognitive Behavioral Group Therapy for Insomnia (GCBT-I)




Primary Outcome Measures :
  1. Change in Insomnia Severity Index score (ISI) (Morin 2011) [ Time Frame: baseline, 12, 24 and 36 weeks from the baseline ]
    A 7-item questionnaire used to assess insomnia severity with a score ranging between 0 to 28. Each questionnaire item addresses an aspect about sleep that is rated by the respondent on a 5-point scale (i.e., 0=no problem to 4=very severe problem).

  2. Change in the health-related quality of life (HRQoL) instrument 15D score (Sintonen, 2001) [ Time Frame: baseline, 12, 24 and 36 weeks from the baseline ]
    The 15D is a generic, comprehensive, 15-dimensional, standardized, self-administered measure of health-related quality of life (HRQoL) that can be used both as a profile and single index score measure. The maximum score is 1 (no problems on any dimension) and the minimum score is 0 (being dead).


Secondary Outcome Measures :
  1. Self-reported subjective sleep quality collected through a digital smartphone app (AIDO Healthcare) [ Time Frame: baseline to week 36 ]
    1-2 times a week by emoji scale 1-5

  2. Self-reported subjective fatigue collected through a digital smartphone app (AIDO Healthcare) [ Time Frame: baseline to week 36 ]
    1-2 times a week by emoji scale 1-5

  3. Self-reported subjective mood collected through a digital smartphone app (AIDO Healthcare) [ Time Frame: baseline to week 36 ]
    1-2 times a week by emoji scale 1-5

  4. Self-reported variables for sleep quantity and quality (adapted from Partinen 1996) [ Time Frame: baseline, 12, 24 and 36 weeks from the baseline ]
    Questions about sleep quantity and quality

  5. Self-reported variables for chronotype (Horne 1976) [ Time Frame: baseline, 12, 24 and 36 weeks from the baseline ]
    Questions about chronotype (morningness-eveningness-)

  6. Self-reported variables for dreaming and nightmares (adapted from Sandman 2015) [ Time Frame: baseline, 12, 24 and 36 weeks from the baseline ]
    Questions about dreaming and nightmares

  7. Self-reported variables for tiredness, fatigue, subjective memory, stress and recovery (Lundqvist 2016) [ Time Frame: baseline, 12, 24 and 36 weeks from the baseline ]
    Questions about tiredness, fatigue, subjective memory, stress and recovery. Scale 1(very good) to 5(very poor).

  8. Self-reported variables for functional ability (adapted from Tuomi 1998). [ Time Frame: baseline, 12, 24 and 36 weeks from the baseline ]
    Questions about functional ability. Scale 0(very poor) to 10(very good).

  9. Self-reported variables for symptoms of depression (Korenke 2001) [ Time Frame: baseline, 12, 24 and 36 weeks from the baseline ]
    Questions about symptoms of depression. Scale 0(not at all) to 3 (Almost Always)

  10. Self-reported variables for symptoms of psychosis (adapted from Haddoc 1999), [ Time Frame: baseline, 12, 24 and 36 weeks from the baseline ]
    Questions about presence, severity, and characteristics of hallucinations, delusions, confused and disturbed thoughts and lack of insight and self-awareness.

  11. Self-reported variables for lifestyle [ Time Frame: baseline, 12, 24 and 36 weeks from the baseline ]
    Questions about exercise, usage of caffeine, alcohol, nicotine.

  12. Subjective measures of Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) (Morin 2007) [ Time Frame: baseline, 12, 24 and 36 weeks from the baseline ]
    DBAS-16 is a 16-item self reported questionnaire to measure people's beliefs and attitudes about their personal sleep situations. Items are ranked from 0, strongly disagree, to 10, strongly agree. Total score is mean of all questions, with a higher score representing more dysfunctional beliefs and attitude about sleep.

  13. Self-reported Feedback Questionnaire [ Time Frame: 12 weeks ]
    Participants experiences from the intervention including habits of practice of the new skills, experience of the effect of the intervention on sleep, mood and lifestyle, alliance with the therapist, the positive and negative effects of the treatment are questioned after the treatment period.

  14. Objective information on sleep from Actigraphy (ACG) data [ Time Frame: baseline (1 week) and week 12(1 week) ]
    The dataset from ACG includes Total Sleep Time (TST), Wake After Sleep Onset (WASO) Bed time, Get up time, Time in bed, Sleep efficiency (SE), Sleep Onset Latency (SOL), One minute immobility and Fragmentation index

  15. Objective information on circadian rhythms from Actigraphy (ACG) data [ Time Frame: baseline (1 week) and week 12(1 week) ]
    The dataset from ACG includes Cosine peak, Light/Dark ratio, Lowest 5 onset, Maximum 10 onset, RA, IV and IS

  16. Subjective sleep diary tracking [ Time Frame: baseline (1 week) and week 12(1 week) ]
    Each morning after waking participants completed the Sleep Diary during the ACG -monitoring period to provide a daily record of self-reported bedtime, get-up time, sleep duration, and daytime naps.

  17. Objective information on activity from EMFIT Sleep Tracker data (Emfit Ltd) [ Time Frame: baseline to week 13 ]
    EMFIT device measures heart rate, breathing rate, movement activity every 4 seconds, sleep staging every 30 seconds, and heart rate variability every 3 minutes.

  18. Objective information on recovery of the autonomic nervous system from EMFIT Sleep Tracker data (Emfit Ltd) [ Time Frame: baseline to week 13 ]
    EMFIT device measures heart rate, breathing rate, movement activity every 4 seconds, sleep staging every 30 seconds, and heart rate variability every 3 minutes.

  19. Cognitive performance is measure with the psychomotor vigilance test (PVT) (Basner 2011) via a web-based interface [ Time Frame: baseline, 12, 24 and 36 weeks from the baseline ]
    PVT is a sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144231


Contacts
Layout table for location contacts
Contact: Tiina M. Paunio, M.D., Ph.D. +358503507936 tiina.paunio@helsinki.fi
Contact: Tuula E. Tanskanen, RN, MHC +358401286262 tuula.tanskanen@hus.fi

Locations
Layout table for location information
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Uusimaa, Finland, 00290
Sponsors and Collaborators
Helsinki University Central Hospital
University of Helsinki
Finnish Institute for Health and Welfare
Finnish Institute of Occupational Health
Investigators
Layout table for investigator information
Principal Investigator: Tiina M. Paunio, M.D., Ph.D. Helsinki University Central Hospital
Additional Information:
Publications:
Edinger JD, Carney CE 2015. Overcoming Insomnia: A Cognitive-Behavioral Therapy Approach. Workbook.Oxford University Press 2015
Lundqvist A, Mäki-Opas T (eds.). Health 2011 Survey - Methods. Terveyden ja hyvinvoinnin laitos, Raportti 8/2016. Helsinki 2016
Morin C, Espie C 2003. Insomnia: A clinical Guide to assessment and treatment. New York. Springer.
Morin C. 2003. Treating insomnia with behavioral approaches: evidence for efficacy, effectiveness, and practicality. In M. P. Szupa, J.D. Kloss & D.F. Dinges (toim), Insomnia. Principles and Management, s. 73-82. Cambridge University press
Tuomi T Ilmarinen J, Jahkola A, Katajarinne l, Tulkki A (1998) Work ability index. Finnish Institute of Occupational Healht, Helsinki
Waters F, Ree M ja Chiu V. Delivering CBT for Insomnia in Psychosis - A clinical guide. New York, Routledge, 2017

Layout table for additonal information
Responsible Party: Tiina M. Paunio, Professor of Psychiatry and Vice Dean of Education / Department of Psychiatry, Faculty of Medicine, University of Helsinki, Research Professor / National Institute for Health and Welfare, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04144231    
Other Study ID Numbers: 1129003, TYH2018219, 30000
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases