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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:
Participants will be asked to take part in 5 examinations during their up to 8-week inpatient treatment:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart rate variability, blood pressure and pulse wave velocity | Diagnostic Test | 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 | Diagnostic Test | 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; Ã…strand-Ryhming Test for cardiorespiratory fitness. All assessments will be performed at first and last week of inpatient treatment. | ||
| Monitoring of physical activity and sleep | Behavioral | GENEActiv accelerometer will be worn on the wrist daily during 8-week inpatient treatment. | ||
| Monitoring of self-rated exhaustion, mood and tension | Behavioral | Using the customized PsyMate app. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline cardiorespiratory fitness at 8 weeks. | Calculated maximal oxygen uptake (VO2max) in (ml/kg/min) based on submaximal testing (Ã…strand-Ryhming Test). | Cardiorespiratory fitness will be measured in the first and last week of up to 8-week inpatient treatment. |
| Global score of the Hamburger Burnout Inventory (HBI) to assess the severity of the burnout syndrome. |
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Inclusion Criteria:
Exclusion Criteria according to medical history:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arno Schmidt-Trucksäss, Prof. | Contact | +41612074741 | arno.schmidt-trucksaess@unibas.ch | |
| Michael Pfaff, Dr. | Contact | +41 81 300 20 37 | m.pfaff@clinica-holistica.ch |
| Name | Affiliation | Role |
|---|---|---|
| Arno Schmidt-Trucksäss, Prof. | University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Holistica Engiadina | Recruiting | Süs | Kanton Graubünden | 7542 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42000525 | Derived | Turner W, La Marca R, Infanger D, Schwendinger F, Bruhl AB, Marschall K, Schulze B, Pfaff M, Boker H, Russmann T, Schmidt-Trucksass A. Heart rate variability across recording conditions: Associations with depression and burnout in inpatients with stress-related disorders. J Psychosom Res. 2026 Aug;207:112674. doi: 10.1016/j.jpsychores.2026.112674. Epub 2026 Apr 12. | |
| 38925684 |
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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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Turner W, Bruhl A, Boker H, Schulze B, Marschall K, La Marca R, Pfaff M, Russmann T, Schmidt-Trucksass A. Heart rate vARiability and physical activity in inpatient treatMent of burnOut and DepressIon (HARMODI): protocol of a cross-sectional study with up to 8-week follow up. BMJ Open. 2024 Jun 25;14(6):e081299. doi: 10.1136/bmjopen-2023-081299. |
| ID | Term |
|---|---|
| D003863 | Depression |
| D000077062 | Burnout, Psychological |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013315 | Stress, Psychological |
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| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| D063177 | Pulse Wave Analysis |
| D000072599 | Cardiorespiratory Fitness |
| D012890 | Sleep |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D010809 | Physical Fitness |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006262 | Health |
| D011154 | Population Characteristics |
| D009424 | Nervous System Physiological Phenomena |
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