Chronobiological and ACT-based Training to Handle Stress at Work

February 26, 2020 updated by: Carolin Reichert, Psychiatric Hospital of the University of Basel

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in subjective exhaustion measured by the German Version of the Shirom-Melamed Burnout Measure
Time Frame: approx. every two weeks, and at follow up (i.e., approx. 5 weeks after last training session)

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Subjective well-being as assessed by General Health Questionnaire (GHQ-12)
Time Frame: approx. every two weeks, and at follow up (i.e., approx. 5 weeks after last training session)
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)
Time Frame: approx. every 4 weeks
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
Time Frame: Actimetric devices are worn during 2 x 28 days continuously. The outcome of actimetric data are aggregated per person and training episode
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)
Time Frame: 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
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
Time Frame: KSS is measured daily
Measured by Karolinska Sleepiness Scale (KSS), higher scores indicate higher sleepiness
KSS is measured daily
Change in daytime subjective sleepiness
Time Frame: ESS approx every four weeks
Measured by Epworth Sleepiness Scale (ESS): higher scores indicate higher sleepiness
ESS approx every four weeks
Change in Chronotype
Time Frame: approx. every 4 weeks and at follow up (i.e., approx. 5 weeks after last training session)
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
Time Frame: every 4 weeks
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
Time Frame: Assessed daily
Numbers of days absent if available from the employer
Assessed daily
Change in Implementation of treatment
Time Frame: approx. every two weeks, and at follow up (i.e., approx. 5 weeks after last training session)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Psychiatric Hospital of the University of Basel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carolin Reichert, PhD, Centre for Chronobiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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