NCT04290117

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 16, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

September 5, 2019

Last Update Submit

February 26, 2020

Conditions

Keywords

Sleep HygieneMorning LightAcceptance and Commitment Training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Change in Subjective well-being as assessed by General Health Questionnaire (GHQ-12)

    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)

    approx. every 4 weeks

  • Change in quality of circadian rhythm

    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)

    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

    KSS is measured daily

  • +5 more secondary outcomes

Study Arms (4)

ACT-Chrono

EXPERIMENTAL

First Acceptance and Commitment (ACT) training, followed by chronobiological training

Behavioral: Acceptance and Commitment TrainingBehavioral: Sleep Hygiene and bright light in the morning

Chrono-ACT

EXPERIMENTAL

First chronobiological training, followed by ACT training

Behavioral: Acceptance and Commitment TrainingBehavioral: Sleep Hygiene and bright light in the morning

Chrono

OTHER

First no training, followed by chronobiological training

Behavioral: Sleep Hygiene and bright light in the morning

ACT

OTHER

First no training, followed by ACT training

Behavioral: Acceptance and Commitment Training

Interventions

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.

ACTACT-ChronoChrono-ACT

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.

ACT-ChronoChronoChrono-ACT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • diseases of the retina or related diseases such as diabetes mellitus
  • taking drugs which heighten photosensitivity
  • inability to understand and follow procedures in German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Chronobiology, UPK Basel

Basel, 4002, Switzerland

RECRUITING

MeSH Terms

Conditions

Sleep Hygiene

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Carolin Reichert, PhD

    Centre for Chronobiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolin Reichert, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 5, 2019

First Posted

February 28, 2020

Study Start

October 16, 2019

Primary Completion

March 1, 2020

Study Completion

April 1, 2020

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations