Heart Rate Variability, Physical Activity and Exhaustion in the Inpatient Treatment of Stress-Related Disorders

Depression Clinical Trial

— HARMODI  

Official title:

Heart Rate Variability, Physical Activity and Exhaustion in the Inpatient Treatment of Stress-Related Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874856
• Other study ID #: 2022-01871
• Status: Recruiting
• Start date: February 8, 2023
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: University of Basel
• Contact: Arno Schmidt-Trucksäss, Prof.
• Phone: +41612074741
• Email: arno.schmidt-trucksaess[@]unibas.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 153
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burnout
• Depression
• Disease
• Psychophysiologic Disorders
• Stress Related Disorder

Intervention

Diagnostic Test:
• Heart rate variability, blood pressure and pulse wave velocity
Resting HRV in supine and standing position, blood pressure and pulse wave velocity in supine position at first and last week of inpatient treatment
• Assessment of cognitive function, balance, strength and cardiorespiratory fitness
THINC-it test for cognitive function; One-leg Standing test for balance assessment; 10-time chair rise test and hand grip test for strength assessment; Åstrand-Ryhming Test for cardiorespiratory fitness. All assessments will be performed at first and last week of inpatient treatment.

Behavioral:
• Monitoring of physical activity and sleep
GENEActiv accelerometer will be worn on the wrist daily during 8-week inpatient treatment.
• Monitoring of self-rated exhaustion, mood and tension
Using the customized PsyMate app.

Locations

Country	Name	City	State
Switzerland	Clinica Holistica Engiadina	Susch	Graubünden

Sponsors (1)

Lead Sponsor	Collaborator
Arno Schmidt-Trucksäss

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Orthostatic Test Heart Rate Variability (HRV) at 8 weeks.	Particular focus is RMSSD in milliseconds, a robust parasympathetic nervous system parameter that is less influenced by body movement and breathing.	Orthostatic Test HRV will be measured in the first and last week of up to 8-week inpatient treatment.
Primary	Change from Baseline 24-hour Heart Rate Variability (HRV) at 8 weeks.	Particular focus is RMSSD in milliseconds, a robust parasympathetic nervous system parameter that is less influenced by body movement and breathing.	24-hour HRV will be measured in the first and last week of up to 8-week inpatient treatment.
Primary	Change from Baseline Exercise Test Heart Rate Variability (HRV) at 8 weeks.	Particular focus is RMSSD in milliseconds, a robust parasympathetic nervous system parameter that is less influenced by body movement and breathing.	Exercise Test HRV will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary	Change from baseline cardiorespiratory fitness at 8 weeks.	Calculated maximal oxygen uptake (VO2max) in (ml/kg/min) based on submaximal testing (Åstrand-Ryhming Test).	Cardiorespiratory fitness will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary	Global score of the Hamburger Burnout Inventory (HBI) to assess the severity of the burnout syndrome.	One item of the 40-item Hamburger Burnout Inventory (HBI) represents a global score on the severity of crisis, which can be rated on a 9-point Likert scale. The Global score can range between 1 and 9, with higher scores indicating worse outcome (worse severity): 1-3 harmless, 4-6 medium and 7-9 need for action.	Severity of Burnout syndrome will be measured in the first week of up to 8-week inpatient treatment.
Secondary	Total score of the Shirom-Melamed-Burnout-Measure (SMBM) will be used measure exhaustion at the beginning of inpatient treatment.	Exhaustion with the three dimensions physical, emotional and cognitive exhaustion will be self-rated on a 7-point Likert scale, ranging from 1 (never) to 7 (always). A total score can vary between 14 and 98, with higher scores reflecting a higher degree of exhaustion / worse outcome.	Exhaustion will be measured in the first week of up to 8-week inpatient treatment.
Secondary	Depression severity will be evaluated with a total score of the German version of the 21-item Beck Depression Inventory-II.	Participants will rate their depressive symptoms over the past two weeks on a 4-point Likert scale. Cut-off scores for patients diagnosed with an affective disorder are calculated by the sum of the total score: 0-10 indicates minimal depression, 10-18 mild to moderate depression, 19-29 moderate to severe depression and 30-63 severe depression.	Depression severity will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary	Change of Vital exhaustion with a total score of the 9-item short form of the original 21-item Maastricht Vital Exhaustion Questionnaire (MVEQ).	Participants will report whether they feel exhausted 0 (no), 1 (uncertain) and 2 (yes), with a total score ranging from 0 to 18; with 4-10 indicating mild, 11-14 substantial and 15-18 severe vital exhaustion.	Vital exhaustion will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary	Anxiety severity will be displayed with a total score of the 21-item Beck Anxiety Inventory.	The 21-item Beck Anxiety Inventory (BAI) will assess anxiety symptoms of the last seven days on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely). A total score can vary between 0 to 63, with 0-7 points indicating minimal anxiety, 8-15 mild, 16-25 moderate and 26-63 clinical anxiety.	Anxiety severity will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary	Mood with a total score of the 14-item German version of the Snaith-Hamilton-Pleasure Scale.	The Snaith-Hamilton-Pleasure Scale (SHAPS-D) will be used to assess self-reported mood on a 4-point Likert scale ranging from "I fully agree" to "I do not agree at all". The participants are asked, related to the last days, to imagine if they feel pleasure in different situations, with a higher total score, ranging between 0 and 14, indicating increased anhedonia.	Mood will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary	Current mood will be shown in total scores of the Multidimensional Mood Questionnaire.	The Multidimensional Mood Questionnaire is a self-rated questionnaire (5-Point Likert Scale) with three dimensions: good-bad mood, alertness-fatigue and calmness-restlessness, with high scores (range between 4 and 20) indicating a positive direction, good mood, alertness and calm state.	Current mood will be measured in the first and last week of up to 8-week inpatient treatment before the HRV measurement.
Secondary	Daily tiredness displayed with a daily score rated with the single item "How tired do you feel at the moment?"	The item "How tired do you feel at the moment?" is an adapted version of one item of the Multidimensional Mood Questionnaire. Participants rate on a 5-Point Likert scale ranging from 1 (not at all) to 5 (completely) how physical tired they feel at the end of the day to capture symptom fluctuations throughout inpatient treatment, with higher scores indicating worse outcome (worse tiredness).	Level of tiredness daily during up to 8-week inpatient treatment
Secondary	Daily mentally exhaustion displayed with the score rated with the single item "How mentally exhausted do you feel at the moment?".	The item "How mentally exhausted do you feel at the moment?" is adapted from the German version of the Perceived Stress Questionnaire.; Participants rate their answers on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely) to capture symptom fluctuations throughout inpatient treatment, with higher scores indicating worse outcome (worse mentally exhaustion).	Level of mentally exhaustion daily during up to 8-week inpatient treatment
Secondary	Daily tension level will be measured with a daily score rated with the single item "How tense do you feel at the moment?".	The item "How tense do you feel at the moment?" is adapted from the German version of the Perceived Stress Questionnaire. Participants rate their answers on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely) to capture symptom fluctuations throughout inpatient treatment, with higher scores indicating worse outcome (higher tension).	Level of tension daily during up to 8-week inpatient treatment
Secondary	Total score of the self-rated 5-item Perceived Deficits Questionnaire.	The abbreviated 5-item version of the Perceived Deficits Questionnaire is part of the THINC-Integrated Tool and can be completed in 2-3 minutes. The total score can range between 5 and 25, with higher scores indicating worse outcome (worse cognitive function).	Cognitive function will be self-rated in the first and last week of up to 8-week inpatient treatment.
Secondary	Attention function will be measured in mean latency for correct responses in milliseconds.	Mean latency for correct responses will be tested with the Spotter test, which is part of the THINC-Integrated tool. The Spotter test is inspired by the Choice Reaction Time Test to measure attention function. Higher values indicate worse outcome (worse attention function).	Cognitive function, such as attention function will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary	Working memory will be displayed in number of correct responses to the Symbol Check test.	The Symbol Check test is part of the THINC-Integrated Tool and inspired by the One-back test to measure working memory, with higher number of correct responses indicating greater outcome (higher working memory).	Cognitive function, such as working memory will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary	Ability to concentrate will be tested with the total number of correct responses to the Codebreaker test.	The Codebreaker test is part of the THINC-Integrated Tool and inspired by the Digit Symbol Substitution Test to identify the ability to concentrate, with higher number of correct responses indicating greater outcome (better ability to concentrate).	Cognitive function, such as ability to concentrate will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary	Executive function will be shown in time taken to complete the Trails test in seconds.	The Trails test is part of the THINC-Integrated Tool and inspired by the Trail Making Test to test executive function, with higher values indicating worse outcome (reduced executive function).	Cognitive function, such as executive function will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary	Self-reported physical activity, objective measured physical activity and sleep displayed in average minutes per day.	Exercise recommendations are expressed in activity intensity and minutes, e.g. 150 minutes of moderate aerobic activity intensity per week.	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.
Secondary	Balance performance in seconds, tested with a variation of the One-Leg Standing test.	The sum in seconds of the left and right leg will be used to show balance performance, with higher values indicating greater outcome (better balance performance).	Balance will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary	Leg strength in time needed to complete the test in seconds, tested with the 10-time chair-rise test.	The reciprocal of time needed to complete the test will be multiplied by 100; consequently, good outcome (strength) will be represented by high scores.	Leg strength will be measured in the first and last week of up to 8-week inpatient treatment.
Secondary	Hand grip strength in kg.	Handheld dynamometer (Jamar Smart Hand Dynamometer, Performance Health Supply Inc., Cedarburg, USA) will be used to test hand grip strength with higher values indicating greater outcome (higher hand grip strength).	Hand grip strength will be assessed in the first and last week of up to 8-week inpatient treatment.
Secondary	Cardiovascular health will be depicted as brachial systolic and diastolic blood pressure (in mm Hg).	Oscillometric cuff-based sphygmomanometer on the right arm (Custo screen 310, custo med GmbH, Ottobrunn, Germany) will be used.	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.
Secondary	Cardiovascular health will be depicted as central systolic and diastolic blood pressure (in mm Hg).	Oscillometric cuff-based sphygmomanometer on the right arm (Custo screen 310, custo med GmbH, Ottobrunn, Germany) will be used.	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.
Secondary	Cardiovascular health will be depicted with pulse wave velocity in m/s.	Oscillometric cuff-based sphygmomanometer on the right arm (Custo screen 310, custo med GmbH, Ottobrunn, Germany) will be used.	Cardiovascular health, such as pulse wave velocity will be assessed in the first and last week of up to 8-week inpatient treatment.