Tailored Treatment of Insomnia in Social and Health Care Sector Shift Workers in Occupational Health Care
NCT ID: NCT06827626
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
84 participants
INTERVENTIONAL
2025-02-17
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cognitive Behavioral Therapy for Insomnia Among Different Types of Shift Workers
NCT02523079
Self-help Cognitive Behavioral Therapy (CBT) for Insomnia
NCT01105052
Sleep Restriction Therapy for Insomnia in Primary Health Care
NCT04975776
Cognitive Behavior Therapy for Insomnia in Primary Care
NCT01655797
Smartphone-delivered CBT-I
NCT05065242
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cognitive Behavioral Therapy for Insomnia
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.
Cognitive behavioral therapy for insomnia
Cognitive-Behavioural Therapy for Insomnia (CBT-I) includes behavioral methods, cognitive methods, and sleep hygiene counselling.
Sleep hygiene counselling
Sleep hygiene counselling is delivered individually (one session) by trained nurses. It includes sleep hygiene instructions tailored to the context of shift work.
Sleep hygiene counselling
Sleep hygiene counselling includes common instructions to improve sleep.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cognitive behavioral therapy for insomnia
Cognitive-Behavioural Therapy for Insomnia (CBT-I) includes behavioral methods, cognitive methods, and sleep hygiene counselling.
Sleep hygiene counselling
Sleep hygiene counselling includes common instructions to improve sleep.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* earlier participation to CBT-I
* other ongoing or planned psychotherapeutic/psychological intervention
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Finnish Work Environment Fund
OTHER
Terveystalo Oyj
UNKNOWN
Joint Authority HUS
UNKNOWN
The Wellbeing Services County of South Ostrobotnia and TT Botnia Oy
UNKNOWN
Finnish Institute of Occupational Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Joint Authority HUS
Helsinki, Uusimaa, Finland
Finnish Institute of Occupational Health
Helsinki, Uusimaa, Finland
Terveystalo Oyj
Helsinki, Uusima, Finland
The Wellbeing Services County of South Ostrobotnia and TT Botnia Oy
Seinäjoki, , Finland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4025601
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.