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

NCT04144231 | Unknown

• 1 other identifier: 1129003, TYH2018219, 30000
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Insomnia; Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (2)

• Change in Insomnia Severity Index score (ISI) (Morin 2011)

  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).

  baseline, 12, 24 and 36 weeks from the baseline

• Change in the health-related quality of life (HRQoL) instrument 15D score (Sintonen, 2001)

  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).

  baseline, 12, 24 and 36 weeks from the baseline

Secondary Outcomes (19)

• Self-reported subjective sleep quality collected through a digital smartphone app (AIDO Healthcare)

  baseline to week 36

• Self-reported subjective fatigue collected through a digital smartphone app (AIDO Healthcare)

  baseline to week 36

• Self-reported subjective mood collected through a digital smartphone app (AIDO Healthcare)

  baseline to week 36

• Self-reported variables for sleep quantity and quality (adapted from Partinen 1996)

  baseline, 12, 24 and 36 weeks from the baseline

• Self-reported variables for chronotype (Horne 1976)

  baseline, 12, 24 and 36 weeks from the baseline

Study Arms (3)

Treatment-as-usual (TAU)

NO INTERVENTION

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.

Internet-Based Cognitive Behavioral Therapy for Insomnia

EXPERIMENTAL

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

Cognitive Behavioral Group Therapy for Insomnia

EXPERIMENTAL

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

Interventions

iCBT-I BEHAVIORAL

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

Internet-Based Cognitive Behavioral Therapy for Insomnia

GCBT-I BEHAVIORAL

Cognitive Behavioral Group Therapy for Insomnia (GCBT-I)

Cognitive Behavioral Group Therapy for Insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ongoing cognitive-behavioral psychotherapy
• diagnosed sleep disorder such as sleep apnea
• insufficient Finnish language skills (insomnia interventions are produced in Finnish, so good Finnish language skills are required)

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator
• Finnish Institute for Health and Welfare: collaborator
• Finnish Institute of Occupational Health: collaborator

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Uusimaa, 00290, Finland

RECRUITING

Related Publications (16)

• 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.

  PMID: 21532951 BACKGROUND

• Edinger JD, Carney CE 2015. Overcoming Insomnia: A Cognitive-Behavioral Therapy Approach. Workbook.Oxford University Press 2015

  BACKGROUND

• 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.

  PMID: 10473315 BACKGROUND

• Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.

  PMID: 1027738 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• Lundqvist A, Mäki-Opas T (eds.). Health 2011 Survey - Methods. Terveyden ja hyvinvoinnin laitos, Raportti 8/2016. Helsinki 2016

  BACKGROUND

• Morin C, Espie C 2003. Insomnia: A clinical Guide to assessment and treatment. New York. Springer.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 18041487 BACKGROUND

• 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.

  PMID: 21532953 BACKGROUND

• 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.

  PMID: 10607192 BACKGROUND

• 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.

  PMID: 25325474 BACKGROUND

• 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.

  PMID: 11491191 BACKGROUND

• Tuomi T Ilmarinen J, Jahkola A, Katajarinne l, Tulkki A (1998) Work ability index. Finnish Institute of Occupational Healht, Helsinki

  BACKGROUND

• Waters F, Ree M ja Chiu V. Delivering CBT for Insomnia in Psychosis - A clinical guide. New York, Routledge, 2017

  BACKGROUND

• 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.

  PMID: 38866575 DERIVED

Related Links

• a study on genetic mechanisms of psychotic disorders and a part of the Stanley Global Initiative

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Tiina M. Paunio, M.D., Ph.D.

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiina M. Paunio, M.D., Ph.D.

CONTACT

+358503507936; tiina.paunio@helsinki.fi

Tuula E. Tanskanen, RN, MHC

CONTACT

+358401286262; tuula.tanskanen@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 30, 2019
• Study Start: December 19, 2019
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)