Clinical trial NCT04290117: Chronobiological and ACT-based Training to Handle Stress at Work
Official title: Chronobiological and Acceptance and Commitment Based Training for the Successful Handling of Stress in the Workplace. A Randomised Crossover Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Keywords: Sleep Hygiene
Morning Light
Acceptance and Commitment Training
Lead sponsor: Psychiatric Hospital of the University of Basel
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the present project is to combine "Acceptance and Commitment Therapy" and "sleep hygiene + light-therapy (so-called chronotherapy)" serially in a sample of employees to reduce levels of subjective exhaustion.


Eligibility criteria: Inclusion Criteria:

* working in an office mainly (i.e., \> 60% of work time)
* Age: ≥18 years old
* Sex: male and female individuals
* Ownership of cell phone with internet connection
* informed consent as documented by signature

Exclusion Criteria:

* diseases of the retina or related diseases such as diabetes mellitus
* taking drugs which heighten photosensitivity
* inability to understand and follow procedures in German

Primary outcomes:
measure: Change in subjective exhaustion measured by the German Version of the Shirom-Melamed Burnout Measure
timeFrame: approx. every two weeks, and at follow up (i.e., approx. 5 weeks after last training session)
Secondary outcomes:
measure: Change in Subjective well-being as assessed by General Health Questionnaire (GHQ-12)
timeFrame: approx. every two weeks, and at follow up (i.e., approx. 5 weeks after last training session)
measure: Change in subjective well-being as assessed by the Patient Health Questionnaire (PHQ-D)
timeFrame: approx. every 4 weeks
measure: Change in quality of circadian rhythm
timeFrame: Actimetric devices are worn during 2 x 28 days continuously. The outcome of actimetric data are aggregated per person and training episode
measure: Change in subjective and objective sleep quality: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: PSQI is collected approx. every four weeks and at follow up (i.e. approx 5 weeks after last training), the single question and actimetric data are measured daily
measure: Change in Subjective sleepiness in the morning
timeFrame: KSS is measured daily
measure: Change in daytime subjective sleepiness
timeFrame: ESS approx every four weeks
measure: Change in Chronotype
timeFrame: approx. every 4 weeks and at follow up (i.e., approx. 5 weeks after last training session)
measure: Change in Burnout severity
timeFrame: every 4 weeks
measure: Change in Absences
timeFrame: Assessed daily
measure: Change in Implementation of treatment
timeFrame: approx. every two weeks, and at follow up (i.e., approx. 5 weeks after last training session)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Centre for Chronobiology, UPK Basel
Study officials:
affiliation: Centre for Chronobiology
name: Carolin Reichert, PhD
role: PRINCIPAL_INVESTIGATOR
References: