An observational study in Depression, Burnout and Stress Related Disorder, sponsored by Arno Schmidt-Trucksäss. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Arno Schmidt-Trucksäss · Observational
Among 91 studies in Depression with a site in Switzerland — 26 open to participants now, 27 under way, 1 of them phase 3. Depression · Switzerland.
Among the 91 studies in Depression with a site in Switzerland, this one is the 9th largest by planned enrollment of the 19 observational ones that give a count, is one of 4 that started in 2023, is one of 19 observational ones, reaches primary completion later than 0 of the 26 other live ones, and was the 65th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
Browse Depression studies →26 of the 91 studies in Depression with a site in Switzerland are open now. Recruiting first, the newest first:
Lindenhofgruppe AG · Sites in Switzerland
Ages 18+
Clinica Holistica Engiadina · Sites in Switzerland
Ages 18–80
University of Zurich · Sites in Switzerland
Ages 18–70
Insel Gruppe AG, University Hospital Bern · Sites in Switzerland
Ages 18+
University of Bern · Sites in Switzerland
Ages 18+
A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
91 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 9 · Phase 3 2 · Phase 4 4
First in 2002; this study’s year is marked. 4 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 153 is below the median of 175 across 1,257 observational studies indexed under Depression.
Median enrollment 82 across the 71 interventional studies, 143 across the 19 observational. Of the 52 that completed or were terminated, 1 (2%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 91 have an industry lead sponsor. The 10 most frequent:
Arno Schmidt-Trucksäss is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Arno Schmidt-Trucksäss has 1 study filed under Depression — fewer than ten, so there is no comparison to draw.
9 of the studies in Depression with a site in Switzerland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07757997Clinica Holistica EngiadinaHealth and Work Ability Following Inpatient Treatment for Stress-related Disorders - Follow-up Study of the HARMODI Cohort | 2026-11 |
| NCT07471529University of ZurichActivating Social Resources in Psychotherapy-Seeking Individuals: Effectiveness and Timing of a Social Support Just-in-Time Adaptive Intervention | 2026-12 |
| NCT06324864Prof. Christina StadlerSTART NOW Adapted: Culturally Adapted Version of START NOW | 2026-12 |
| NCT06305182Gabriella MilosMetreleptin in Anorexia Nervosa | 2026-12-31 |
| NCT06197711University of ZurichThe Short-term Effects of PRISMA on Mental Health | 2026-12-31 |
Among the 91 studies in Depression with a site in Switzerland, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria according to medical history:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Resting HRV in supine and standing position, blood pressure and pulse wave velocity in supine position at first and last week of inpatient treatment
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.
GENEActiv accelerometer will be worn on the wrist daily during 8-week inpatient treatment.
Using the customized PsyMate app.
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.
Time frame: 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.
Time frame: 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.
Time frame: Exercise Test HRV will be measured in the first and last week of up to 8-week inpatient treatment.
Change from baseline cardiorespiratory fitness at 8 weeks.
Calculated maximal oxygen uptake (VO2max) in (ml/kg/min) based on submaximal testing (Åstrand-Ryhming Test).
Time frame: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Cardiovascular health, such as pulse wave velocity will be assessed in the first and last week of up to 8-week inpatient treatment.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Apr 2024, 14 months after the start.
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Arno Schmidt-Trucksäss