Clinical trial NCT05874856: Heart Rate Variability, Physical Activity and Exhaustion in the Inpatient Treatment of Stress-Related Disorders
Official title: Heart Rate Variability, Physical Activity and Exhaustion in the Inpatient Treatment of Stress-Related Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Burnout
Stress Related Disorder
Keywords: Stress Related Disorder
Heart Rate Variability
Physical Activity
Exhaustion
Inpatient Treatment
Cardiorespiratory fitness
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited among patients referred to the rehabilitation clinic with the diagnosis of an ICD-10 depressive episode (F32 or F33) and burnout (Z73), confirmed by experienced psychiatrists working in the clinic.

Brief summary: The goal of this observational study is to learn about heart rate variability and physical activity in inpatients with stress-related disorder. The main questions to answer are:

* whether heart rate variability shows the severity of certain symptoms.
* whether physical activity has an influence on heart rate variability and symptoms of stress-related disorder.

Participants will be asked to take part in 5 examinations during their up to 8-week inpatient treatment:

* Participate in an interview
* Measurement of heart rate variability, blood pressure and health of the arteries (pulse wave velocity)
* Tests of endurance, strength, balance and cognitive abilities
* Completion of two additional short questionnaires
* Wearing a 24-hour electrocardiogram
* Wearing a fitness watch and daily self-assessment of fatigue, mood and tension via an app on participant's mobile phone during their stay.


Eligibility criteria: Inclusion Criteria:

* diagnosis of an ICD-10 depressive episode (F32 or F33) and burnout (Z73) without psychotic symptoms
* German language skills
* mobile phone ownership
* age 18-35 years

Exclusion Criteria according to medical history:

* comorbid psychiatric disorder, including post-traumatic stress disorder as well as anxiety and panic disorder
* current treatment with antiarrhythmic drugs and tricyclic antidepressant medication
* factors precluding submaximal endurance test: history of cardiac diseases such as myocardial infarction, stroke and unstable heart failure within the previous six months impairing exercise testing and training, and heart failure (New York Heart Association functional class III and IV)
* factors severely affecting HRV parameters: type 1 \& 2 diabetes mellitus with clinically proven cardiovascular autonomic neuropathy, chronic obstructive pulmonary disease Global Initiative for Obstructive Lung Disease stage ≥ III, ongoing cancer treatment, moderate to severe chronic kidney disease (estimated Glomerular Filtration Rate stage 3a (G3a) or worse (≤ 45 ml/min)), current eating disorders such as anorexia nervosa and bulimia nervosa, excessive drug or alcohol abuse
* known pregnancy
* suicidal thoughts precluding informed consent

Primary outcomes:
measure: Change from Baseline Orthostatic Test Heart Rate Variability (HRV) at 8 weeks.
timeFrame: Orthostatic Test HRV will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Change from Baseline 24-hour Heart Rate Variability (HRV) at 8 weeks.
timeFrame: 24-hour HRV will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Change from Baseline Exercise Test Heart Rate Variability (HRV) at 8 weeks.
timeFrame: Exercise Test HRV will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary outcomes:
measure: Change from baseline cardiorespiratory fitness at 8 weeks.
timeFrame: Cardiorespiratory fitness will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Global score of the Hamburger Burnout Inventory (HBI) to assess the severity of the burnout syndrome.
timeFrame: Severity of Burnout syndrome will be measured in the first week of up to 8-week inpatient treatment.
measure: Total score of the Shirom-Melamed-Burnout-Measure (SMBM) will be used measure exhaustion at the beginning of inpatient treatment.
timeFrame: Exhaustion will be measured in the first week of up to 8-week inpatient treatment.
measure: Depression severity will be evaluated with a total score of the German version of the 21-item Beck Depression Inventory-II.
timeFrame: Depression severity will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Change of Vital exhaustion with a total score of the 9-item short form of the original 21-item Maastricht Vital Exhaustion Questionnaire (MVEQ).
timeFrame: Vital exhaustion will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Anxiety severity will be displayed with a total score of the 21-item Beck Anxiety Inventory.
timeFrame: Anxiety severity will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Mood with a total score of the 14-item German version of the Snaith-Hamilton-Pleasure Scale.
timeFrame: Mood will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Current mood will be shown in total scores of the Multidimensional Mood Questionnaire.
timeFrame: Current mood will be measured in the first and last week of up to 8-week inpatient treatment before the HRV measurement.
measure: Daily tiredness displayed with a daily score rated with the single item "How tired do you feel at the moment?"
timeFrame: Level of tiredness daily during up to 8-week inpatient treatment
measure: Daily mentally exhaustion displayed with the score rated with the single item "How mentally exhausted do you feel at the moment?".
timeFrame: Level of mentally exhaustion daily during up to 8-week inpatient treatment
measure: Daily tension level will be measured with a daily score rated with the single item "How tense do you feel at the moment?".
timeFrame: Level of tension daily during up to 8-week inpatient treatment
measure: Total score of the self-rated 5-item Perceived Deficits Questionnaire.
timeFrame: Cognitive function will be self-rated in the first and last week of up to 8-week inpatient treatment.
measure: Attention function will be measured in mean latency for correct responses in milliseconds.
timeFrame: Cognitive function, such as attention function will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Working memory will be displayed in number of correct responses to the Symbol Check test.
timeFrame: Cognitive function, such as working memory will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Ability to concentrate will be tested with the total number of correct responses to the Codebreaker test.
timeFrame: Cognitive function, such as ability to concentrate will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Executive function will be shown in time taken to complete the Trails test in seconds.
timeFrame: Cognitive function, such as executive function will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Self-reported physical activity, objective measured physical activity and sleep displayed in average minutes per day.
timeFrame: Self-reported physical activity will be screened ones during first week of inpatient treatment. Objective measured physical activity and sleep daily during up to 8-week inpatient treatment.
measure: Balance performance in seconds, tested with a variation of the One-Leg Standing test.
timeFrame: Balance will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Leg strength in time needed to complete the test in seconds, tested with the 10-time chair-rise test.
timeFrame: Leg strength will be measured in the first and last week of up to 8-week inpatient treatment.
measure: Hand grip strength in kg.
timeFrame: Hand grip strength will be assessed in the first and last week of up to 8-week inpatient treatment.
measure: Cardiovascular health will be depicted as brachial systolic and diastolic blood pressure (in mm Hg).
timeFrame: Cardiovascular health, such as brachial systolic and diastolic blood pressure will be assessed in the first and last week of up to 8-week inpatient treatment.
measure: Cardiovascular health will be depicted as central systolic and diastolic blood pressure (in mm Hg).
timeFrame: Cardiovascular health, such as central systolic and diastolic blood pressure will be assessed in the first and last week of up to 8-week inpatient treatment.
measure: Cardiovascular health will be depicted with pulse wave velocity in m/s.
timeFrame: Cardiovascular health, such as pulse wave velocity will be assessed in the first and last week of up to 8-week inpatient treatment.
Other outcomes:
Locations:
city: Susch
country: Switzerland
facility: Clinica Holistica Engiadina
state: Graubünden
Study officials:
affiliation: University of Basel
name: Arno Schmidt-Trucksäss, Prof.
role: PRINCIPAL_INVESTIGATOR
References: