InsomniaSLEEPINSNCT04144231
Cognitive Behavioral Therapy for Insomnia (CBT-I) in Schizophrenia(SLEEPINS)
A study testing iCBT-I and GCBT-I in people with Insomnia and Schizophrenia, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- iCBT-I and GCBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 19 Dec 2019to 6 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki, Uusimaa, 00290
About this study
Official title: Cognitive Behavioral Therapy for Insomnia (CBT-I) in Schizophrenia - A Randomized Controlled Clinical Trial (SLEEPINS)
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).
Read the 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.
- Conditions
- Insomnia, Schizophrenia, Schizoaffective Disorder
- Being tested
- iCBT-I, GCBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBT-IBehavioural
Internet-Based Cognitive Behavioral Therapy for Insomnia (ICBT-I) with the support of a therapist, delivered by mobile application (HUS iCBT-I)
GCBT-IBehavioural
Cognitive Behavioral Group Therapy for Insomnia (GCBT-I)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: GCBT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
1-2 times a week by emoji scale 1-5
Measured: baseline to week 36
Self-reported subjective fatigue collected through a digital smartphone app (AIDO Healthcare)
1-2 times a week by emoji scale 1-5
Measured: baseline to week 36
Self-reported subjective mood collected through a digital smartphone app (AIDO Healthcare)
1-2 times a week by emoji scale 1-5
Measured: baseline to week 36
Self-reported variables for sleep quantity and quality (adapted from Partinen 1996)
Questions about sleep quantity and quality
Measured: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for chronotype (Horne 1976)
Questions about chronotype (morningness-eveningness-)
Measured: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for dreaming and nightmares (adapted from Sandman 2015)
Questions about dreaming and nightmares
Measured: baseline, 12, 24 and 36 weeks from the baseline
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).
Measured: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for functional ability (adapted from Tuomi 1998).
Questions about functional ability. Scale 0(very poor) to 10(very good).
Measured: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for symptoms of depression (Korenke 2001)
Questions about symptoms of depression. Scale 0(not at all) to 3 (Almost Always)
Measured: baseline, 12, 24 and 36 weeks from the baseline
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.
Measured: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for lifestyle
Questions about exercise, usage of caffeine, alcohol, nicotine.
Measured: baseline, 12, 24 and 36 weeks from the baseline
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.
Measured: baseline, 12, 24 and 36 weeks from the baseline
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.
Measured: 12 weeks
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
Measured: baseline (1 week) and week 12(1 week)
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
Measured: baseline (1 week) and week 12(1 week)
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.
Measured: baseline (1 week) and week 12(1 week)
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.
Measured: baseline to week 13
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.
Measured: baseline to week 13
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
Measured: baseline, 12, 24 and 36 weeks from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start19 Dec 2019
- Primary completion6 Sep 2024 (estimated)
- Study completion6 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Finnish Institute for Health and Welfare, Finnish Institute of Occupational Health
- Responsible party
- Principal investigator, Tiina M. Paunio, Helsinki University Central Hospital
- Investigators
- Tiina M. Paunio, M.D., Ph.D., Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144231
- Sponsor's protocol ID
- 1129003, TYH2018219, 30000
- Acronym
- SLEEPINS
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2019
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon completion of the clinical trial, data will be made available upon reasonable request and by the review of ethics Committee of the Hospital District of Helsinki and Uusimaa, Finland
Publications
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.
PubMed 21532951Edinger 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.
PubMed 10473315Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
PubMed 1027738Kroenke 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.
PubMed 11556941Lundqvist 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.
PubMed 18041487Morin 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.
PubMed 21532953Partinen 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.
PubMed 10607192Sandman 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.
PubMed 25325474Sintonen 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.
PubMed 11491191Tuomi 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia (CBT-I) in Schizophrenia - A Randomized Controlled Clinical Trial (SLEEPINS)
- ClinicalTrials.gov ID
- NCT04144231
- Acronym / sponsor ID
- SLEEPINS / 1129003, TYH2018219, 30000
- Conditions
- Insomnia, Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki, Finnish Institute for Health and Welfare, Finnish Institute of Occupational Health
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 6 Sep 2024 (estimated)
- Study completion
- 6 Sep 2024 (estimated)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: iCBT-ITAU 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. |
| Cognitive Behavioral Group Therapy for Insomnia | Experimental | Behavioral: GCBT-ITAU 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCBT-IInternet-Based Cognitive Behavioral Therapy for Insomnia (ICBT-I) with the support of a therapist, delivered by mobile application (HUS iCBT-I) | Behavioural | Internet-Based Cognitive Behavioral Therapy for Insomnia |
| GCBT-ICognitive Behavioral Group Therapy for Insomnia (GCBT-I) | Behavioural | Cognitive Behavioral Group Therapy for Insomnia |
Primary outcome
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).
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).
19 secondary outcomes
Self-reported subjective sleep quality collected through a digital smartphone app (AIDO Healthcare)
Time frame: baseline to week 36
Self-reported subjective fatigue collected through a digital smartphone app (AIDO Healthcare)
Time frame: baseline to week 36
Self-reported subjective mood collected through a digital smartphone app (AIDO Healthcare)
Time frame: baseline to week 36
Self-reported variables for sleep quantity and quality (adapted from Partinen 1996)
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for chronotype (Horne 1976)
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for dreaming and nightmares (adapted from Sandman 2015)
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for tiredness, fatigue, subjective memory, stress and recovery (Lundqvist 2016)
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for functional ability (adapted from Tuomi 1998).
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for symptoms of depression (Korenke 2001)
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for symptoms of psychosis (adapted from Haddoc 1999),
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported variables for lifestyle
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Subjective measures of Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) (Morin 2007)
Time frame: baseline, 12, 24 and 36 weeks from the baseline
Self-reported Feedback Questionnaire
Time frame: 12 weeks
Objective information on sleep from Actigraphy (ACG) data
Time frame: baseline (1 week) and week 12(1 week)
Objective information on circadian rhythms from Actigraphy (ACG) data
Time frame: baseline (1 week) and week 12(1 week)
Subjective sleep diary tracking
Time frame: baseline (1 week) and week 12(1 week)
Objective information on activity from EMFIT Sleep Tracker data (Emfit Ltd)
Time frame: baseline to week 13
Objective information on recovery of the autonomic nervous system from EMFIT Sleep Tracker data (Emfit Ltd)
Time frame: baseline to week 13
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Background: PubMed 21532951Basner 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.
- BackgroundEdinger JD, Carney CE 2015. Overcoming Insomnia: A Cognitive-Behavioral Therapy Approach. Workbook.Oxford University Press 2015
- Background: PubMed 10473315Haddock 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.
- Background: PubMed 1027738Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
- Background: PubMed 11556941Kroenke 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.
- BackgroundLundqvist A, Mäki-Opas T (eds.). Health 2011 Survey - Methods. Terveyden ja hyvinvoinnin laitos, Raportti 8/2016. Helsinki 2016
- BackgroundMorin C, Espie C 2003. Insomnia: A clinical Guide to assessment and treatment. New York. Springer.
- BackgroundMorin 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: PubMed 18041487Morin 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.
- Background: PubMed 21532953Morin 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.
- Background: PubMed 10607192Partinen 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.
- Background: PubMed 25325474Sandman 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.
- a study on genetic mechanisms of psychotic disorders and a part of the Stanley Global InitiativeLink provided by the sponsor.
- Individual participant dataSharing planned: No. Upon completion of the clinical trial, data will be made available upon reasonable request and by the review of ethics Committee of the Hospital District of Helsinki and Uusimaa, Finland
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiina M. Paunio, M.D., Ph.D. principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCBT-I and GCBT-I in people with Insomnia and Schizophrenia, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiina M. Paunio, M.D., Ph.D. (+358503507936, tiina.paunio@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index score (ISI) (Morin 2011) (time frame: baseline, 12, 24 and 36 weeks from the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04144231, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.