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

Schizophrenia Clinical Trial

— SLEEPINS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144231
• Other study ID #: 1129003, TYH2018219, 30000
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: September 6, 2024

Study information

• Verified date: October 2023
• Source: Helsinki University Central Hospital
• Contact: Tiina M. Paunio, M.D., Ph.D.
• Phone: +358503507936
• Email: tiina.paunio[@]helsinki.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 6, 2024
• Est. primary completion date: September 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Insomnia
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Sleep Initiation and Maintenance Disorders

Intervention

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)
• GCBT-I
Cognitive Behavioral Group Therapy for Insomnia (GCBT-I)

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki	Uusimaa

Sponsors (4)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Finnish Institute for Health and Welfare, Finnish Institute of Occupational Health, University of Helsinki

Country where clinical trial is conducted

Finland, 

References & Publications (15)

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. — View Citation

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. — View Citation

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

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. — View Citation

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, 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Self-reported subjective sleep quality collected through a digital smartphone app (AIDO Healthcare)	1-2 times a week by emoji scale 1-5	baseline to week 36
Secondary	Self-reported subjective fatigue collected through a digital smartphone app (AIDO Healthcare)	1-2 times a week by emoji scale 1-5	baseline to week 36
Secondary	Self-reported subjective mood collected through a digital smartphone app (AIDO Healthcare)	1-2 times a week by emoji scale 1-5	baseline to week 36
Secondary	Self-reported variables for sleep quantity and quality (adapted from Partinen 1996)	Questions about sleep quantity and quality	baseline, 12, 24 and 36 weeks from the baseline
Secondary	Self-reported variables for chronotype (Horne 1976)	Questions about chronotype (morningness-eveningness-)	baseline, 12, 24 and 36 weeks from the baseline
Secondary	Self-reported variables for dreaming and nightmares (adapted from Sandman 2015)	Questions about dreaming and nightmares	baseline, 12, 24 and 36 weeks from the baseline
Secondary	Self-reported variables for tiredness, fatigue, subjective memory, stress and recovery (Lundqvist 2016)	Questions about tiredness, fatigue, subjective memory, stress and recovery. Scale 1(very good) to 5(very poor).	baseline, 12, 24 and 36 weeks from the baseline
Secondary	Self-reported variables for functional ability (adapted from Tuomi 1998).	Questions about functional ability. Scale 0(very poor) to 10(very good).	baseline, 12, 24 and 36 weeks from the baseline
Secondary	Self-reported variables for symptoms of depression (Korenke 2001)	Questions about symptoms of depression. Scale 0(not at all) to 3 (Almost Always)	baseline, 12, 24 and 36 weeks from the baseline
Secondary	Self-reported variables for symptoms of psychosis (adapted from Haddoc 1999),	Questions about presence, severity, and characteristics of hallucinations, delusions, confused and disturbed thoughts and lack of insight and self-awareness.	baseline, 12, 24 and 36 weeks from the baseline
Secondary	Self-reported variables for lifestyle	Questions about exercise, usage of caffeine, alcohol, nicotine.	baseline, 12, 24 and 36 weeks from the baseline
Secondary	Subjective measures of Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) (Morin 2007)	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.	baseline, 12, 24 and 36 weeks from the baseline
Secondary	Self-reported Feedback Questionnaire	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.	12 weeks
Secondary	Objective information on sleep from Actigraphy (ACG) data	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	baseline (1 week) and week 12(1 week)
Secondary	Objective information on circadian rhythms from Actigraphy (ACG) data	The dataset from ACG includes Cosine peak, Light/Dark ratio, Lowest 5 onset, Maximum 10 onset, RA, IV and IS	baseline (1 week) and week 12(1 week)
Secondary	Subjective sleep diary tracking	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.	baseline (1 week) and week 12(1 week)
Secondary	Objective information on activity from EMFIT Sleep Tracker data (Emfit Ltd)	EMFIT device measures heart rate, breathing rate, movement activity every 4 seconds, sleep staging every 30 seconds, and heart rate variability every 3 minutes.	baseline to week 13
Secondary	Objective information on recovery of the autonomic nervous system from EMFIT Sleep Tracker data (Emfit Ltd)	EMFIT device measures heart rate, breathing rate, movement activity every 4 seconds, sleep staging every 30 seconds, and heart rate variability every 3 minutes.	baseline to week 13
Secondary	Cognitive performance is measure with the psychomotor vigilance test (PVT) (Basner 2011) via a web-based interface	PVT is a sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus	baseline, 12, 24 and 36 weeks from the baseline

External Links

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