Chronobiological and ACT-based Training to Handle Stress at Work

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

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.

Study Overview

• Status: Unknown
• Conditions: Stress
• Intervention / Treatment: Behavioral: Acceptance and Commitment Training; Behavioral: Sleep Hygiene and bright light in the morning

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolin Reichert, PhD; Phone Number: +41 61 325 5508; Email: carolin.reichert@upk.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4002
    • Recruiting
    • Centre for Chronobiology, UPK Basel
    • Contact: Carolin Reichert, PhD; Email: carolin.reichert@upk.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT-Chrono; First Acceptance and Commitment (ACT) training, followed by chronobiological training	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.; Behavioral: 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.
Experimental: Chrono-ACT; First chronobiological training, followed by ACT training	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.; Behavioral: 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.
Other: Chrono; First no training, followed by chronobiological training	Behavioral: 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.
Other: ACT; First no training, followed by ACT training	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
Change in Subjective sleepiness in the morning	Measured by Karolinska Sleepiness Scale (KSS), higher scores indicate higher sleepiness	KSS is measured daily
Change in daytime subjective sleepiness	Measured by Epworth Sleepiness Scale (ESS): higher scores indicate higher sleepiness	ESS approx every four weeks
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)
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
Change in Absences	Numbers of days absent if available from the employer	Assessed daily
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)

Collaborators and Investigators

• Sponsor: Psychiatric Hospital of the University of Basel
• Investigators: Principal Investigator: Carolin Reichert, PhD, Centre for Chronobiology

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Sleep Hygiene; Morning Light; Acceptance and Commitment Training
• Other Study ID Numbers: 2019-01318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No