Insomnia ChronicSote-VURHOTNCT06827626

Tailored Treatment of Insomnia in Social and Health Care Sector Shift Workers in Occupational Health Care

A study testing Cognitive behavioral therapy for insomnia and Sleep hygiene counselling in people with Insomnia Chronic and Shift Work Sleep Disorder, run by Finnish Institute of Occupational Health at 4 sites in Finland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Insomnia Chronic, Shift Work Sleep Disorder
What is being tested?: Cognitive behavioral therapy for insomnia and Sleep hygiene counselling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 4 sitesFinland
Study dates: 17 Feb 2025to 31 Mar 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age 18-65 years
working in social and heath care sector
3- or 2-shift work including night shift at least once per month
full time or nearly full time shift work (75-100 %)
Insomnia Severity Index score > 10
duration of insomnia symptoms at least 3 months
shift work continuing for at least the next year
sufficient Finnish language skills (coaching materials in Finnish only)

Who cannot join

non-assessed or untreated clinically significant somatic or mental symptoms or illnesses or other sleep disorders that could explain current insomnia symptoms
earlier participation to CBT-I
other ongoing or planned psychotherapeutic/psychological intervention

Trial locations and contacts

4 sites in 1 country.

Finland4 sites

Joint Authority HUS
Helsinki, Uusimaa, FI-00029
Finnish Institute of Occupational Health
Helsinki, Uusimaa, FI-00032
Terveystalo Oyj
Helsinki, Uusima, FI-00100
The Wellbeing Services County of South Ostrobotnia and TT Botnia Oy
Seinäjoki

Other trials in Finland

About this study

The goal of this clinical trial is to evaluate the usefulness of cognitive behavioural therapy for insomnia (CBT-I) tailored to shift workers in the social and health care sector. The study will also learn about the shift workers' experiences of the acceptability and feasibility of CBT-I and investigate which features of shift work and individual characteristics promote or interfere with the effectiveness of the tailored CBT-I.

The main question the study aims to answer is:

Does CBT-I tailored to shift workers in the social and health care sector improve perceived insomnia severity, insomnia symptoms, mental health and quality of life?

Researchers will compare CBT-I to a control intervention (short sleep hygiene counselling) to see if CBT-I works to treat insomnia in shift workers.

Participants will:

Participate in the research intervention (CBT-I tailored to the shift work context; six individual sessions) or the control intervention (sleep hygiene counselling; one individual session)
Complete the measures (sleep diary, actigraphy and questionnaires) at baseline, after the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.

Read the detailed description

Disturbed sleep and insomnia are common among shift workers, and disturbed sleep is considered a key factor in other health risks associated with shift work. However, there are no established treatment practices for treating insomnia in shift workers. This study aims to evaluate the effectiveness of Cognitive-Behavioural Therapy for Insomnia (CBT-I) tailored for social and health care sector shift workers whose work includes night shifts. Furthermore, the study will assess the shift workers' experiences of the acceptability and feasibility of CBT-I from their perspective. The study will also examine which features of shift work and employee characteristics promote or interfere with the effectiveness of the tailored CBT-I.

The study is a randomised controlled trial. Participants will be shift workers in the social and health care sector who work in three or two shifts, including night shifts, and have significant insomnia symptoms. Participants will be recruited through occupational health services (OHS) and social media posts. The FIOH study group will carry out the measurements of the participants. Participants will complete the baseline measures (sleep diary, actigraphy and questionnaires) and then will be randomly assigned to receive the research intervention (CBT-I tailored to the shift work context; six individual sessions) or the control intervention (sleep hygiene counselling; one individual session). The interventions will be delivered by the nurses of the participants´ OHS and the FIOH. Participants will complete the follow-up measures after the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.

The results of the study can be utilised in OHS to guide and treat shift workers with insomnia as part of supporting their work ability.

Conditions: Insomnia Chronic, Shift Work Sleep Disorder
Being tested: Cognitive behavioral therapy for insomnia, Sleep hygiene counselling
Keywords: Shift work, Insomnia, Shift work sleep disorder, CBT-I, Occupational Health Services
Medical subject headings: Sleep Initiation and Maintenance Disorders, Sleep Disorders, Circadian Rhythm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive behavioral therapy for insomniaBehavioural
Also called CBT-I
Cognitive-Behavioural Therapy for Insomnia (CBT-I) includes behavioral methods, cognitive methods, and sleep hygiene counselling.
Sleep hygiene counsellingBehavioural
Also called Sleep hygiene
Sleep hygiene counselling includes common instructions to improve sleep.

Study groups in NCT06827626
Study group	Role	What they receive
Cognitive Behavioral Therapy for Insomnia	Experimental	Cognitive-Behavioural Therapy for Insomnia (CBT-I) is tailored for shift workers in social and health care sector. CBT-I is delivered individually (six sessions) by trained nurses. It includes behavioral methods (sleep compression tailored for shift work context), cognitive methods, and shift work related sleep hygiene counselling. Receives: Behavioral: Cognitive behavioral therapy for insomnia
Sleep hygiene counselling	Active comparator	Sleep hygiene counselling is delivered individually (one session) by trained nurses. It includes sleep hygiene instructions tailored to the context of shift work. Receives: Behavioral: Sleep hygiene counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in mean of Insomnia Severity Index at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Insomnia Severity Index (ISI) contains seven items about insomnia during the last month [item scale 0 (not at all) -4 (very severe)]. The sum of the scores serves as the ISI score.
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.

Secondary outcomes (12)

Change from baseline in means of insomnia symptoms assessed by sleep diary at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Insomnia symptoms are assessed by sleep diary. It is completed using a mobile phone app (Experience Sampling Platform - movisensXS - movisens GmbH). The sleep diary contains questions about the timing of the sleep period, sleep onset latency, wake after sleep onset, number of awakenings after sleep onset, sleep quality, time spent in bed, restedness after sleep, use of sleep-promoting medication, working times, recovery from work, naps and their timing. Total sleep time and sleep efficiency are calculated from the responses. The averages will serve as the outcomes. Participants will keep the sleep diary for 1-2 weeks at each measurement period.
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in means of insomnia symptoms assessed by actigraphy at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Insomnia symptoms are also assessed using the Actigraphy Link GT9X. Actigraphy recording is conducted for 1-2 weeks at the same time as the sleep diary. From the actigraphy data, we analyse sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency, naps and their timing. The averages will serve as the outcomes.
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in shift work disorder case at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Shift-specific questions on insomnia and sleepiness (SS-Q) -questionnaire measures separately sleepiness and insomnia symptoms in three different shifts (morning, evening and night shifts) and while on holiday over two weeks [item scale 1 (never) - 5 (always)]. Shift work disorder (SWD) cases has to report sleepiness and/or insomnia "never" or "rarely" while on holiday and the never or rarely occurring symptom "often" or "always" in connection to some shift type/types. SWD score [0 (no SWD) or 1(SWD case)] is used as outcome.
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean insomnia reactivity at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
The Ford Insomnia Response to Stress Test (FIRST) contains nine items about insomnia reactivity in potentially stressful situations [item scale 1 (not likely) - 4 (very likely)]. The sum of the scores serves as the FIRST score.
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean of sleep-related dysfunctional cognitions at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Sleep-related Beliefs and Attitudes about Sleep (DBAS-16) -questionnaire contains 16 items to assesses sleep-related dysfunctional cognitions [item scale 0 (strongly disagree) - 10 (strongly agree)]. The average of the scores serve as the DBAS score.
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean daytime sleepiness at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
The Epworth Sleepiness Scale (ESS) contains eight items to measure the subject's general level of daytime sleepiness in different situations [item scale 0 (would never nod off) - 3 (high chance of nodding off)]. The sum of the scores serves as the ESS score.
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean depression severity at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
The Patient Health Questionnaire (PHQ-9) contains nine items to measure depression severity [item scale 0 (not at all) - 3 (nearly every day)]. The sum of the scores serves as the PHQ-9 score.
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean anxiety disorder symptoms at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
The GAD-7 contains seven items measuring the severity of the symptoms of generalised anxiety disorder [item scale 0 (not at all) - 3 (nearly every day)]. The sum of the scores serves as the GAD-7 score.
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean burnout symptoms at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
The Burnout Assessment Tool (BAT-12) contains 12 items measuring burnout symptoms [item scale 1 (never) - 5 (always)]. The average of the scores serves as the BAT-12 score.
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean quality of life at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
EuroHIS-8 contains 8 items measuring the quality of life [item scale 1 (worst outcome) - 5 (best outcome)]. The sum of the scores serves as the EUROHIS-8 score.
Power, M. (2003). Development of a common instrument for quality of life. In A. Nosikov \& C. Gudex (edit.), EUROHIS: Developing Common Instruments for Health Surveys (145-159). Amsterdam, Holland: IOS Press.
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean self-rated work ability at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Work ability measure includes an item measuring self-rated work ability (item scale 0 (not at all) - 10 (very good)].
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean recovery at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
The recovery measure includes an item measuring recovery from work [item scale 1 (badly) - 5 (well)]. In this study, recovery is measured separately in four different shifts (morning, day, evening and night shifts).
Measured: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 202531 Mar 2027

First posted14 Feb 2025
Study start17 Feb 2025
Primary completion15 Mar 2027 (estimated)
Study completion31 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Insomnia ChronicStudies of the same condition, open and under way.
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: Single blind
Who is masked: Investigator
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06827626
Sponsor's protocol ID: 4025601
Acronym: Sote-VURHOT
Status last verified: Apr 2026
First submitted: 7 Feb 2025
Last updated: 13 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Study participants do not give informed consent to have their IPD published (anonymised).

Publications

Ell J, Bruckner HA, Johann AF, Steinmetz L, Guth LJ, Feige B, Jarnefelt H, Vallieres A, Frase L, Domschke K, Riemann D, Lehr D, Spiegelhalder K. Digital cognitive behavioural therapy for insomnia reduces insomnia in nurses suffering from shift work disorder: A randomised-controlled pilot trial. J Sleep Res. 2024 Dec;33(6):e14193. doi: 10.1111/jsr.14193. Epub 2024 Mar 14.
PubMed 38485134
Seligman ME. The effectiveness of psychotherapy. The Consumer Reports study. Am Psychol. 1995 Dec;50(12):965-74. doi: 10.1037//0003-066x.50.12.965.
PubMed 8561380
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459
Hadzibajramovic E, Schaufeli W, De Witte H. Shortening of the Burnout Assessment Tool (BAT)-from 23 to 12 items using content and Rasch analysis. BMC Public Health. 2022 Mar 22;22(1):560. doi: 10.1186/s12889-022-12946-y.
PubMed 35313849
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.
PubMed 11556941
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PubMed 1798888
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 18041487
Kalmbach DA, Pillai V, Arnedt JT, Drake CL. Identifying At-Risk Individuals for Insomnia Using the Ford Insomnia Response to Stress Test. Sleep. 2016 Feb 1;39(2):449-56. doi: 10.5665/sleep.5462.
PubMed 26446111
Vanttola P, Puttonen S, Karhula K, Oksanen T, Harma M. Prevalence of shift work disorder among hospital personnel: A cross-sectional study using objective working hour data. J Sleep Res. 2020 Jun;29(3):e12906. doi: 10.1111/jsr.12906. Epub 2019 Aug 14.
PubMed 31410909
Natale V, Plazzi G, Martoni M. Actigraphy in the assessment of insomnia: a quantitative approach. Sleep. 2009 Jun;32(6):767-71. doi: 10.1093/sleep/32.6.767.
PubMed 19544753
Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
PubMed 22294820
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.
PubMed 21532953

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tailored Treatment of Insomnia in Social and Health Care Sector Shift Workers in Occupational Health Care
ClinicalTrials.gov ID: NCT06827626
Acronym / sponsor ID: Sote-VURHOT / 4025601
Conditions: Insomnia Chronic, Shift Work Sleep Disorder
Keywords: Shift work, Insomnia, Shift work sleep disorder, CBT-I, Occupational Health Services
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 84 participants (estimated)
Lead sponsor: Finnish Institute of Occupational HealthUniversity, hospital or other
Collaborators: Finnish Work Environment Fund, Terveystalo Oyj, Joint Authority HUS, The Wellbeing Services County of South Ostrobotnia and TT Botnia Oy
Study start: 17 Feb 2025 (actual)
Primary completion: 15 Mar 2027 (estimated)
Study completion: 31 Mar 2027 (estimated)
First posted: 14 Feb 2025 (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.

The main question the study aims to answer is:

Does CBT-I tailored to shift workers in the social and health care sector improve perceived insomnia severity, insomnia symptoms, mental health and quality of life?

Researchers will compare CBT-I to a control intervention (short sleep hygiene counselling) to see if CBT-I works to treat insomnia in shift workers.

Participants will:

Participate in the research intervention (CBT-I tailored to the shift work context; six individual sessions) or the control intervention (sleep hygiene counselling; one individual session)
Complete the measures (sleep diary, actigraphy and questionnaires) at baseline, after the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.

Detailed description

The results of the study can be utilised in OHS to guide and treat shift workers with insomnia as part of supporting their work ability.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Cognitive Behavioral Therapy for Insomnia	Experimental	Behavioral: Cognitive behavioral therapy for insomniaCognitive-Behavioural Therapy for Insomnia (CBT-I) is tailored for shift workers in social and health care sector. CBT-I is delivered individually (six sessions) by trained nurses. It includes behavioral methods (sleep compression tailored for shift work context), cognitive methods, and shift work related sleep hygiene counselling.
Sleep hygiene counselling	Active comparator	Behavioral: Sleep hygiene counsellingSleep hygiene counselling is delivered individually (one session) by trained nurses. It includes sleep hygiene instructions tailored to the context of shift work.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

age 18-65 years
working in social and heath care sector
3- or 2-shift work including night shift at least once per month
full time or nearly full time shift work (75-100 %)
Insomnia Severity Index score > 10

Key exclusion criteria (3 listed)

non-assessed or untreated clinically significant somatic or mental symptoms or illnesses or other sleep disorders that could explain current insomnia symptoms
earlier participation to CBT-I
other ongoing or planned psychotherapeutic/psychological intervention

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
Cognitive behavioral therapy for insomniaAlso: CBT-ICognitive-Behavioural Therapy for Insomnia (CBT-I) includes behavioral methods, cognitive methods, and sleep hygiene counselling.	Behavioural	Cognitive Behavioral Therapy for Insomnia
Sleep hygiene counsellingAlso: Sleep hygieneSleep hygiene counselling includes common instructions to improve sleep.	Behavioural	Sleep hygiene counselling

Primary outcome

Change from baseline in mean of Insomnia Severity Index at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Insomnia Severity Index (ISI) contains seven items about insomnia during the last month [item scale 0 (not at all) -4 (very severe)]. The sum of the scores serves as the ISI score.

12 secondary outcomes

Change from baseline in means of insomnia symptoms assessed by sleep diary at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in means of insomnia symptoms assessed by actigraphy at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in shift work disorder case at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean insomnia reactivity at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean of sleep-related dysfunctional cognitions at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean daytime sleepiness at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean depression severity at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean anxiety disorder symptoms at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean burnout symptoms at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean quality of life at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean self-rated work ability at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.
Change from baseline in mean recovery at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment.
Time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
Results publication: PubMed 38485134Ell J, Bruckner HA, Johann AF, Steinmetz L, Guth LJ, Feige B, Jarnefelt H, Vallieres A, Frase L, Domschke K, Riemann D, Lehr D, Spiegelhalder K. Digital cognitive behavioural therapy for insomnia reduces insomnia in nurses suffering from shift work disorder: A randomised-controlled pilot trial. J Sleep Res. 2024 Dec;33(6):e14193. doi: 10.1111/jsr.14193. Epub 2024 Mar 14.
Results publication: PubMed 8561380Seligman ME. The effectiveness of psychotherapy. The Consumer Reports study. Am Psychol. 1995 Dec;50(12):965-74. doi: 10.1037//0003-066x.50.12.965.
Results publication: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
Results publication: PubMed 35313849Hadzibajramovic E, Schaufeli W, De Witte H. Shortening of the Burnout Assessment Tool (BAT)-from 23 to 12 items using content and Rasch analysis. BMC Public Health. 2022 Mar 22;22(1):560. doi: 10.1186/s12889-022-12946-y.
Results publication: 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.
Results publication: PubMed 1798888Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
Results publication: 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.
Results publication: PubMed 26446111Kalmbach DA, Pillai V, Arnedt JT, Drake CL. Identifying At-Risk Individuals for Insomnia Using the Ford Insomnia Response to Stress Test. Sleep. 2016 Feb 1;39(2):449-56. doi: 10.5665/sleep.5462.
Results publication: PubMed 31410909Vanttola P, Puttonen S, Karhula K, Oksanen T, Harma M. Prevalence of shift work disorder among hospital personnel: A cross-sectional study using objective working hour data. J Sleep Res. 2020 Jun;29(3):e12906. doi: 10.1111/jsr.12906. Epub 2019 Aug 14.
Results publication: PubMed 19544753Natale V, Plazzi G, Martoni M. Actigraphy in the assessment of insomnia: a quantitative approach. Sleep. 2009 Jun;32(6):767-71. doi: 10.1093/sleep/32.6.767.
Results publication: PubMed 22294820Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
Results publication: 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.
Project web pageLink provided by the sponsor.
Individual participant dataSharing planned: No. Study participants do not give informed consent to have their IPD published (anonymised).

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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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in mean of Insomnia Severity Index at the end of treatment (12 weeks after the first session) and at 6 months after the end of treatment. (time frame: From baseline to the end of treatment (12 weeks after the first session) and to the 6 months after the end of treatment.). 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 NCT06827626, which also lists 12 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 13 Apr 2026.