Cognitive Behavioral Therapy for Insomnia (CBT-I) in Schizophrenia(SLEEPINS)
NCT ID: NCT04144231
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2019-12-19
2024-09-06
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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.
iCBT-I
Internet-Based Cognitive Behavioral Therapy for Insomnia (ICBT-I) with the support of a therapist, delivered by mobile application (HUS iCBT-I)
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.
GCBT-I
Cognitive Behavioral Group Therapy for Insomnia (GCBT-I)
Interventions
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iCBT-I
Internet-Based Cognitive Behavioral Therapy for Insomnia (ICBT-I) with the support of a therapist, delivered by mobile application (HUS iCBT-I)
GCBT-I
Cognitive Behavioral Group Therapy for Insomnia (GCBT-I)
Eligibility Criteria
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Inclusion 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
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)
18 Years
ALL
No
Sponsors
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University of Helsinki
OTHER
Finnish Institute for Health and Welfare
OTHER_GOV
Finnish Institute of Occupational Health
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
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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
Principal Investigators
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Tiina M. Paunio, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
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Helsinki University Central Hospital
Helsinki, Uusimaa, Finland
Countries
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Central Contacts
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References
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Basner M, Dinges DF. Maximizing sensitivity of the psychomotor vigilance test (PVT) to sleep loss. Sleep. 2011 May 1;34(5):581-91. doi: 10.1093/sleep/34.5.581.
Edinger JD, Carney CE 2015. Overcoming Insomnia: A Cognitive-Behavioral Therapy Approach. Workbook.Oxford University Press 2015
Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999 Jul;29(4):879-89. doi: 10.1017/s0033291799008661.
Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
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
Morin CM, Vallieres A, Ivers H. Dysfunctional beliefs and attitudes about sleep (DBAS): validation of a brief version (DBAS-16). Sleep. 2007 Nov;30(11):1547-54. doi: 10.1093/sleep/30.11.1547.
Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
Partinen M, Gislason T. Basic Nordic Sleep Questionnaire (BNSQ): a quantitated measure of subjective sleep complaints. J Sleep Res. 1995 Jun;4(S1):150-155. doi: 10.1111/j.1365-2869.1995.tb00205.x.
Sandman N, Valli K, Kronholm E, Revonsuo A, Laatikainen T, Paunio T. Nightmares: risk factors among the Finnish general adult population. Sleep. 2015 Apr 1;38(4):507-14. doi: 10.5665/sleep.4560.
Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med. 2001 Jul;33(5):328-36. doi: 10.3109/07853890109002086.
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
Tanskanen TE, Wegelius A, Harkonen T, Gummerus EM, Stenberg JH, Selinheimo SIK, Alakuijala A, Tenhunen M, Paajanen T, Jarnefelt H, Kajaste S, Blom K, Kieseppa T, Tuisku K, Paunio T. Cognitive behavioural therapy for insomnia (CBT-I) in schizophrenia and schizoaffective disorder: protocol for a randomised controlled trial. BMJ Open. 2024 Jun 12;14(6):e076129. doi: 10.1136/bmjopen-2023-076129.
Related Links
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a study on genetic mechanisms of psychotic disorders and a part of the Stanley Global Initiative
Other Identifiers
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1129003, TYH2018219, 30000
Identifier Type: -
Identifier Source: org_study_id
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