Chronobiological and ACT-based Training to Handle Stress at Work

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Training
* Behavioral: Sleep Hygiene and bright light in the morning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT-Chrono<br>First Acceptance and Commitment (ACT) training, followed by chronobiological training | Behavioral: Acceptance and Commitment Training<br>* 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.<br>Behavioral: Sleep Hygiene and bright light in the morning<br>* 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.<br>|
| Experimental: Chrono-ACT<br>First chronobiological training, followed by ACT training | Behavioral: Acceptance and Commitment Training<br>* 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.<br>Behavioral: Sleep Hygiene and bright light in the morning<br>* 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.<br>|
| Other: Chrono<br>First no training, followed by chronobiological training | Behavioral: Sleep Hygiene and bright light in the morning<br>* 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.<br>|
| Other: ACT<br>First no training, followed by ACT training | Behavioral: Acceptance and Commitment Training<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Hygiene, Morning Light, Acceptance and Commitment Training