Chronobiological and ACT-based Training to Handle Stress at Work

Stress Clinical Trial

Official title:

Chronobiological and Acceptance and Commitment Based Training for the Successful Handling of Stress in the Workplace. A Randomised Crossover Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04290117
• Other study ID #: 2019-01318
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: April 2020

Study information

• Verified date: February 2020
• Source: Psychiatric Hospital of the University of Basel
• Contact: Carolin Reichert, PhD
• Phone: +41 61 325 5508
• Email: carolin.reichert[@]upk.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Acceptance and Commitment Training
During the ACT-based intervention, participants will get 4 training sessions in groups, once a week for an hour. Additionally, participants will be asked to implement behavioural exercises such as mindfulness and value-based exercises into their daily schedule.
• Sleep Hygiene and bright light in the morning
During the chronobiological intervention, participants will get 4 training sessions in groups, one hour per week. Additionally, they will use a daylight lamp at home, for 30 minutes per day after waking up.

Locations

Country	Name	City	State
Switzerland	Centre for Chronobiology, UPK Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Psychiatric Hospital of the University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in subjective exhaustion measured by the German Version of the Shirom-Melamed Burnout Measure	Overall mean score as well as three subscales of Shirom-Melamed Burnout Measure ( P = physical fatigue; E= emotional exhaustion; and C= cognitive weariness, each ranging from 1-7).; Note: Higher scores indicate higher levels of exhaustion (overall as well as on each scale P, E and C)	approx. every two weeks, and at follow up (i.e., approx. 5 weeks after last training session)
Secondary	Change in Subjective well-being as assessed by General Health Questionnaire (GHQ-12)	Sum over twelve items, higher scores indicate worse psychological well-being	approx. every two weeks, and at follow up (i.e., approx. 5 weeks after last training session)
Secondary	Change in subjective well-being as assessed by the Patient Health Questionnaire (PHQ-D)	Sum over each of the subscales assessing somatic, depressive, anxiety and stress symptoms. The subscale assessing panic symptoms, alcohol abuse and intake of medication will be categorically evaluated.	approx. every 4 weeks
Secondary	Change in quality of circadian rhythm	Actimetric devices are worn during 2 x 28 days continuously. These devices store the amount of activity in a resolution of 30 Hz 24/7. For data analyses, these activity data will be aggregated to three values (stability, variability and relative amplitude) per participant and training episode by non-parametric circadian rhythm analyses; higher values indicate higher stability, variability and amplitude	Actimetric devices are worn during 2 x 28 days continuously. The outcome of actimetric data are aggregated per person and training episode
Secondary	Change in subjective and objective sleep quality: Pittsburgh Sleep Quality Index (PSQI)	Subjectively assessed by the Pittsburgh Sleep Quality Index (PSQI, higher scores indicate worse subjective sleep quality), by a single question about sleep quality (higher scores indicate worse quality) and by actimetric analyses	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
Secondary	Change in Subjective sleepiness in the morning	Measured by Karolinska Sleepiness Scale (KSS), higher scores indicate higher sleepiness	KSS is measured daily
Secondary	Change in daytime subjective sleepiness	Measured by Epworth Sleepiness Scale (ESS): higher scores indicate higher sleepiness	ESS approx every four weeks
Secondary	Change in Chronotype	Measured by a short version of the Munich Chronotype Questionnaire, higher scores indicate a later chronotype	approx. every 4 weeks and at follow up (i.e., approx. 5 weeks after last training session)
Secondary	Change in Burnout severity	Measured by Maslach Burnout Inventory using sumscores of the subscales emotional exhaustion, depersonalization and personal achievement. Higher scores indicate higher exhaustion, depersonalization and better personal achievement	every 4 weeks
Secondary	Change in Absences	Numbers of days absent if available from the employer	Assessed daily
Secondary	Change in Implementation of treatment	Questions about frequency implementation of treatment in daily life	approx. every two weeks, and at follow up (i.e., approx. 5 weeks after last training session)