Depression - Major Depressive DisorderNCT07757997
Health and Work Ability Following Inpatient Treatment for Stress-related Disorders - Follow-up Study of the HARMODI Cohort
An observational study of Depression - Major Depressive Disorder and Adjustment Disorder, run by Clinica Holistica Engiadina at 2 sites in Switzerland.
Trial summary
When treating stress-related conditions, it is important to understand how health and work ability develop over the long term. In our research project, we aim, firstly, to investigate how health and work ability develop over the three years following inpatient treatment, and, secondly, to identify the factors that… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Adjustment Disorder, Burnout Syndrome
- How many people
- 143 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Aug 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants of the HARMODI study had the following inclusion criteria: * diagnosis of depressive episode (F32 or F33) as well as burnout (Z73) without psychotic symptoms according to ICD-10, * German language skills, * smartphone ownership, * age 18-65 years. Exclusion criteria: * comorbid post-traumatic stress disorder as well as anxiety and panic disorder * current treatment with antiarrhythmic drugs and tricyclic antidepressant medication * history of cardiac diseases such as myocardial infarction, stroke and unstable heart failure within the previous six months impairing exercise testing and training, * heart failure (NYHA III and IV) * type 1 \& 2 diabetes mellitus with cardiovascular autonomic neuropathy, * COPD GOLD stage ≥ III, * ongoing cancer treatment, * moderate to severe chronic kidney disease (eGFR stage 3a (G3a) or worse (≤ 45 ml/min)), * current anorexia nervosa and bulimia nervosa, * drug or alcohol abuse, * known pregnancy, * suicidal thoughts
Who may be able to join
- Previously participatiom in the HARMODI study (No. 2022-01871)
- Completion of inpatient treatment at the Clinica Holistica Engiadina
Who cannot join
- Withdraw of consent for participation in the HARMODI study.
- Participants who cannot be reached despite predefined contact attempts (e.g., invalid email or postal address or telephone number)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Clinica Holistica Engiadina
Süs, 7542
Namir Lababidi, Dipl., +41 81 300 20 30, Namir.Lababidi@clinica-holistica.ch
- Recruiting
Clinica Holistica Engiadina
Süs, 7542
Namir Lababidi, Dipl., +41 81 300 20 30, Namir.Lababidi@clinica-holistica.ch
About this study
When treating stress-related conditions, it is important to understand how health and work ability develop over the long term. In our research project, we aim, firstly, to investigate how health and work ability develop over the three years following inpatient treatment, and, secondly, to identify the factors that influence a return to work and work ability. Former inpatients undergoing treatment for stress-related disorders who took part in the HARMODI-study will be invited to complete online questionnaires up to three years after their discharge from the clinic. The online questionnaires contain questions regarding current work ability, mental and physical health as well as the process of return to work after discharge.
Read the detailed description
Burnout and depression are associated with substantial personal suffering as well as high societal and economic costs due to prolonged sick leave and reduced productivity. While inpatient multimodal treatment is effective in reducing symptoms at discharge, less is known about long-term mental and physical health, occupational functioning, and return to work (RTW). Existing evidence suggests that mental and physical health generally improve following treatment, but nevertheless symptoms often persist in the long term. Moreover, there is limited evidence on RTW after inpatient treatment, particularly regarding long-term trajectories and relapse. A better understanding of predictive indicators of work ability and RTW after treatment is therefore required.
To address this gap, this follow-up study of the HARMODI cohort aims to investigate psychophysiological health, work ability, and RTW up to three years after treatment at the Clinica Holistica Engiadina. By combining self-reported outcomes with previously assessed post-treatment cardiorespiratory fitness, HRV, and cognitive function, this study provides a comprehensive perspective on long-term recovery. The findings aim to inform the optimization of treatment programs and support public health policymaking.
This study is a monocentric retrospective longitudinal exploratory cohort study conducted at the Clinica Holistica Engiadina.Questionnaire data on psychophysiological health, RTW, and work ability will be assessed from former study participants of the HARMODI study (No. 2022-01871) up to three years after discharge from inpatient treatment. In addition, existing data from the HARMODI study will be used to investigate potential associations between time to RTW and post-treatment changes in depression severity, cardiorespiratory fitness, HRV, and cognitive function.
All former HARMODI participants who did not withdraw informed consent will be invited to comple online questionnaires up to three years after their discharge from the clinic.
- Keywords
- Depression, Burnout, Return to Work, long-term treatment effects, work ability, mental health
- Medical subject headings
- Adjustment Disorders, Burnout, Psychological, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| former participants of the HARMODI cohort | The study population consists of former participants of the HARMODI study who underwent inpatient treatment for stress-related disorders at the Clinica Holistica Engiadina. HARMODI participants were diagnosed with either a depressive disorder or an adjustment disorder and provieded a burnout syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Return to Work (RTW)
Primary endpoint will be time to RTW, assessed as the number of days between discharge from inpatient treatment and the first documented partial, respectively full RTW, assessed up to 40 months.
Partial RTW is defined as returning to any occupational position with reduced working hours. Full RTW is defined as resuming the originally contractually agreed workload that was held prior to admission to the clinic.
Measured: From discharge from inpatient treatment until the first documented partial, respectively full RTW, assessed up to 40 months.
Secondary outcomes (6)
Trajectories of work ability
Participants will rate their work ability, respectively, sick leave from one up to 25 months after discharge from the clinic on a 10-point Likert scale ranging from 0 incapacity to work to 10 fully able to work.
Measured: Retrospective rating at follow-up: work ability from one up to 25 months after discharge from the clinic
Work ability at follow-up
Work ability will be self-rated up to three years after discharge using the first item of the Work Ability Index (Hasselhorn \& Freude, 2007; Tuomi et al., 1998), named the work ability score. The work ability score assesses the subjective estimation of one's present work ability compared with one's lifetime best and has been proven to be a simple, valid, and distinctive indicator to assess work ability (Ahlstrom et al., 2010; Ebener \& Hasselhorn, 2019; Kinnunen \& Nätti, 2018; Mokarami et al., 2022), with higher scores reflecting more favourable work ability.
Measured: Up to three years after discharge
Symptom burden at follow-up
Somatic, depression, and anxiety symptoms will be self-rated up to three years after discharge using the German version of the 18-item version (BSI-18) (Spitzer et al., 2011) of the 53-item Brief Symptom Inventory (BSI) (Geisheim et al., 2002). Participants will rate their symptom severity on a 5-point Likert scale, ranging from 0 not at all to 4 very strongly, during the past seven days. Somatic, depression, and anxiety symptoms are each rated with six items, summarized to a global severity index, with higher scores indicating higher symptom burden (Spitzer et al., 2011).
Measured: Up to three years after discharge
Sleep quality at follow-up
Sleep quality of the last month will be self-rated up to three years after discharge using the 6-item Brief Version (Sancho-Domingo et al., 2021) of the Pittsburgh Sleep Quality Index (Buysse et al., 1989) (B-PSQI). The B-PSQI is a brief, reliable, and valid measure to assess sleep efficiency, sleep quality, night awakening, hours of sleep, and sleep latency, resulting in a total score ranging from 0 to 15, with higher scores reflecting reduced sleep quality (Sancho-Domingo et al., 2021).
Measured: Up to three years after discharge
Physical activity at follow-up
Physical activity (PA) will be self-rated up to three years after discharge using two adapted items from the short version of the International Physical Activity Questionnaire (IPAQ) (Craig et al., 2003). The adapted items will assess frequency and duration of moderate to vigorous PA during the past 7 days.
Measured: Up to three years after discharge
Resilience at follow-up
Resilience will be self-rated up to three years after discharge using the 2-item abbreviated version (Vaishnavi et al., 2007) of the Connor-Davidson Resilience Scale (Connor \& Davidson, 2003) (CD-RISC2). The CD-RISC2 is a brief measure of resilience with sound psychometric properties (Vaishnavi et al., 2007). Participants will be asked to rate how well they were able to adapt to change, respectively, tend to bounce back after illness or hardship during the past month, on a 5-point Likert scale, ranging from 0 not true at all to 4 almost always true, with higher scores indicating greater resilience.
Measured: Up to three years after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Holistica Engiadina
- Sponsor type
- University, hospital or other
- Collaborators
- University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health
- Responsible party
- Sponsor
- Investigators
- Namir Lababidi, Dipl., Principal investigator, Clinica Holistica Engiadina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757997
- Sponsor's protocol ID
- HARMODI Follow-up
- Other IDs
- CHE
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38925684
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Work Ability Following Inpatient Treatment for Stress-related Disorders - Follow-up Study of the HARMODI Cohort
- ClinicalTrials.gov ID
- NCT07757997
- Acronym / sponsor ID
- HARMODI Follow-up
- Keywords
- Depression, Burnout, Return to Work, long-term treatment effects, work ability, mental health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Clinica Holistica EngiadinaUniversity, hospital or other
- Collaborators
- University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health
- Study start
- Aug 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When treating stress-related conditions, it is important to understand how health and work ability develop over the long term. In our research project, we aim, firstly, to investigate how health and work ability develop over the three years following inpatient treatment, and, secondly, to identify the factors that influence a return to work and work ability. Former inpatients undergoing treatment for stress-related disorders who took part in the HARMODI-study will be invited to complete online questionnaires up to three years after their discharge from the clinic. The online questionnaires contain questions regarding current work ability, mental and physical health as well as the process of return to work after discharge.
Detailed description
Burnout and depression are associated with substantial personal suffering as well as high societal and economic costs due to prolonged sick leave and reduced productivity. While inpatient multimodal treatment is effective in reducing symptoms at discharge, less is known about long-term mental and physical health, occupational functioning, and return to work (RTW). Existing evidence suggests that mental and physical health generally improve following treatment, but nevertheless symptoms often persist in the long term. Moreover, there is limited evidence on RTW after inpatient treatment, particularly regarding long-term trajectories and relapse. A better understanding of predictive indicators of work ability and RTW after treatment is therefore required.
To address this gap, this follow-up study of the HARMODI cohort aims to investigate psychophysiological health, work ability, and RTW up to three years after treatment at the Clinica Holistica Engiadina. By combining self-reported outcomes with previously assessed post-treatment cardiorespiratory fitness, HRV, and cognitive function, this study provides a comprehensive perspective on long-term recovery. The findings aim to inform the optimization of treatment programs and support public health policymaking.
This study is a monocentric retrospective longitudinal exploratory cohort study conducted at the Clinica Holistica Engiadina.Questionnaire data on psychophysiological health, RTW, and work ability will be assessed from former study participants of the HARMODI study (No. 2022-01871) up to three years after discharge from inpatient treatment. In addition, existing data from the HARMODI study will be used to investigate potential associations between time to RTW and post-treatment changes in depression severity, cardiorespiratory fitness, HRV, and cognitive function.
All former HARMODI participants who did not withdraw informed consent will be invited to comple online questionnaires up to three years after their discharge from the clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| former participants of the HARMODI cohort | – | –The study population consists of former participants of the HARMODI study who underwent inpatient treatment for stress-related disorders at the Clinica Holistica Engiadina. HARMODI participants were diagnosed with either a depressive disorder or an adjustment disorder and provieded a burnout syndrome. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants of the HARMODI study had the following inclusion criteria: * diagnosis of depressive episode (F32 or F33) as well as burnout (Z73) without psychotic symptoms according to ICD-10, * German language skills, * smartphone ownership, * age 18-65 years. Exclusion criteria: * comorbid post-traumatic stress disorder as well as anxiety and panic disorder * current treatment with antiarrhythmic drugs and tricyclic antidepressant medication * history of cardiac diseases such as myocardial infarction, stroke and unstable heart failure within the previous six months impairing exercise testing and training, * heart failure (NYHA III and IV) * type 1 \& 2 diabetes mellitus with cardiovascular autonomic neuropathy, * COPD GOLD stage ≥ III, * ongoing cancer treatment, * moderate to severe chronic kidney disease (eGFR stage 3a (G3a) or worse (≤ 45 ml/min)), * current anorexia nervosa and bulimia nervosa, * drug or alcohol abuse, * known pregnancy, * suicidal thoughts
Key inclusion criteria (2 listed)
- Previously participatiom in the HARMODI study (No. 2022-01871)
- Completion of inpatient treatment at the Clinica Holistica Engiadina
Key exclusion criteria (2 listed)
- Withdraw of consent for participation in the HARMODI study.
- Participants who cannot be reached despite predefined contact attempts (e.g., invalid email or postal address or telephone number)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Return to Work (RTW)
Time frame: From discharge from inpatient treatment until the first documented partial, respectively full RTW, assessed up to 40 months.
Primary endpoint will be time to RTW, assessed as the number of days between discharge from inpatient treatment and the first documented partial, respectively full RTW, assessed up to 40 months. Partial RTW is defined as returning to any occupational position with reduced working hours. Full RTW is defined as resuming the originally contractually agreed workload that was held prior to admission to the clinic.
6 secondary outcomes
Trajectories of work ability
Time frame: Retrospective rating at follow-up: work ability from one up to 25 months after discharge from the clinic
Work ability at follow-up
Time frame: Up to three years after discharge
Symptom burden at follow-up
Time frame: Up to three years after discharge
Sleep quality at follow-up
Time frame: Up to three years after discharge
Physical activity at follow-up
Time frame: Up to three years after discharge
Resilience at follow-up
Time frame: Up to three years after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 38925684Turner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Namir Lababidi, Dipl. principal investigator
Clinica Holistica Engiadina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression - Major Depressive Disorder and Adjustment Disorder, run by Clinica Holistica Engiadina at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wiebke Turner, MoA (0813002030 ext. +41 81 300 26, wiebke.turner@clinica-holistica.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Return to Work (RTW) (time frame: From discharge from inpatient treatment until the first documented partial, respectively full RTW, assessed up to 40 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07757997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.