StressNCT04290117
Chronobiological and ACT-based Training to Handle Stress at Work
A study testing Acceptance and Commitment Training and Sleep Hygiene and bright light in the morning in people with Stress, run by Psychiatric Hospital of the University of Basel at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Acceptance and Commitment Training and Sleep Hygiene and bright light in the morning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Oct 2019to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- diseases of the retina or related diseases such as diabetes mellitus
- taking drugs which heighten photosensitivity
- inability to understand and follow procedures in German
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Centre for Chronobiology, UPK Basel
Basel, 4002
Carolin Reichert, PhD, carolin.reichert@upk.ch
About this study
Official title: 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.
- Conditions
- Stress
- Being tested
- Acceptance and Commitment Training, Sleep Hygiene and bright light in the morning
- Keywords
- Sleep Hygiene, Morning Light, Acceptance and Commitment Training
- Medical subject headings
- Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TrainingBehavioural
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 morningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACT-Chrono | Experimental | First Acceptance and Commitment (ACT) training, followed by chronobiological training Receives: Behavioral: Acceptance and Commitment Training; Behavioral: Sleep Hygiene and bright light in the morning |
| Chrono-ACT | Experimental | First chronobiological training, followed by ACT training Receives: Behavioral: Acceptance and Commitment Training; Behavioral: Sleep Hygiene and bright light in the morning |
| Chrono | Other | First no training, followed by chronobiological training Receives: Behavioral: Sleep Hygiene and bright light in the morning |
| ACT | Other | First no training, followed by ACT training Receives: Behavioral: Acceptance and Commitment Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: approx. every two weeks, and at follow up (i.e., approx. 5 weeks after last training session)
Secondary outcomes (10)
Change in Subjective well-being as assessed by General Health Questionnaire (GHQ-12)
Sum over twelve items, higher scores indicate worse psychological well-being
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: KSS is measured daily
Change in daytime subjective sleepiness
Measured by Epworth Sleepiness Scale (ESS): higher scores indicate higher sleepiness
Measured: ESS approx every four weeks
Change in Chronotype
Measured by a short version of the Munich Chronotype Questionnaire, higher scores indicate a later chronotype
Measured: 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
Measured: every 4 weeks
Change in Absences
Numbers of days absent if available from the employer
Measured: Assessed daily
Change in Implementation of treatment
Questions about frequency implementation of treatment in daily life
Measured: approx. every two weeks, and at follow up (i.e., approx. 5 weeks after last training session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start16 Oct 2019
- Primary completionMar 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatric Hospital of the University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolin Reichert, Psychiatric Hospital of the University of Basel
- Investigators
- Carolin Reichert, PhD, Principal investigator, Centre for Chronobiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290117
- Sponsor's protocol ID
- 2019-01318
- Other IDs
- 2019
- Status last verified
- Feb 2020
- First submitted
- 5 Sep 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronobiological and Acceptance and Commitment Based Training for the Successful Handling of Stress in the Workplace. A Randomised Crossover Clinical Study
- ClinicalTrials.gov ID
- NCT04290117
- Acronym / sponsor ID
- 2019-01318
- Conditions
- Stress
- Keywords
- Sleep Hygiene, Morning Light, Acceptance and Commitment Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Psychiatric Hospital of the University of BaselUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ACT-Chrono | Experimental | Behavioral: Acceptance and Commitment Training, Behavioral: Sleep Hygiene and bright light in the morningFirst Acceptance and Commitment (ACT) training, followed by chronobiological training |
| Chrono-ACT | Experimental | Behavioral: Acceptance and Commitment Training, Behavioral: Sleep Hygiene and bright light in the morningFirst chronobiological training, followed by ACT training |
| Chrono | Other | Behavioral: Sleep Hygiene and bright light in the morningFirst no training, followed by chronobiological training |
| ACT | Other | Behavioral: Acceptance and Commitment TrainingFirst no training, followed by ACT training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- diseases of the retina or related diseases such as diabetes mellitus
- taking drugs which heighten photosensitivity
- inability to understand and follow procedures in German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TrainingDuring 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. | Behavioural | ACT, ACT-Chrono, Chrono-ACT |
| Sleep Hygiene and bright light in the morningDuring 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. | Behavioural | ACT-Chrono, Chrono, Chrono-ACT |
Primary outcome
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)
10 secondary outcomes
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)
Change in subjective well-being as assessed by the Patient Health Questionnaire (PHQ-D)
Time frame: 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
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
Change in Subjective sleepiness in the morning
Time frame: KSS is measured daily
Change in daytime subjective sleepiness
Time frame: 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)
Change in Burnout severity
Time frame: every 4 weeks
Change in Absences
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolin Reichert, PhD principal investigator
Centre for Chronobiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Training and Sleep Hygiene and bright light in the morning in people with Stress, run by Psychiatric Hospital of the University of Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolin Reichert, PhD (+41 61 325 5508, carolin.reichert@upk.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.