An observational study in Depression - Major Depressive Disorder, Adjustment Disorder and Burnout Syndrome, sponsored by Clinica Holistica Engiadina. Recruiting at 2 sites in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Clinica Holistica Engiadina · Observational
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.
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.
63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.
This study's planned enrollment of 143 is below the median of 231 across 10 observational studies indexed under Adjustment Disorders.
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Participants of the HARMODI study had the following inclusion criteria:
Exclusion criteria:
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Exclusion Criteria:
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.
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.
Time frame: From discharge from inpatient treatment until the first documented partial, respectively full RTW, assessed up to 40 months.
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.
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
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Up to three years after discharge
Cardiorespiratory fitness during inpatient treatment
Cardiorespiratory fitness was assessed during the HARMODI study with the submaximal Åstrand-Ryhming Test to calculate maximal oxygen uptake VO2max in ml/kg/min.
Time frame: Baseline and end of inpatient treatment (up to 8 weeks).
Exhaustion during inpatient treatment
Exhaustion symptoms were assessed during the HARMODI study at baseline and end of inpatient treatment (up to 8 weeks) using the German version of the 9-item short form (Kopp et al., 1998; Schnorpfeil et al., 2002) of the original 21-item Maastricht Vital Exhaustion Questionnaire (MVEQ) (Appels et al., 1987). Participants reported whether they feel exhausted 0 (no), 1 (uncertain) and 2 (yes), with total scores 4-10 indicating mild, 11-14 substantial and 15-18 severe vital exhaustion (Kopp et al., 1998).
Time frame: Baseline and end of inpatient treatment (up to 8 weeks).
Depression during inpatient treatment
Depression severity was self-rated during the HARMODI study at baseline and end of inpatient treatment (up to 8 weeks) with the German version of the (Wang \& Gorenstein, 2013) 21-item Beck Depression Inventory-II (BDI-II) (Kühner et al., 2007). Participants were asked to describe their depressive symptoms over the past two weeks on a 4-point Likert scale, ranging from 0 (no presence of a symptom) to 3 (strong presence of a symptom) (Aaron T. Beck et al., 1988), with higher scores indicating worse depression.
Time frame: Baseline and end of inpatient treatment (up to 8 weeks).
Anxiety during inpatient treatment
Anxiety symptoms were assessed during the HARMODI study using the German version of the 21-item Beck Anxiety Inventory (BAI) at baseline and end of inpatient treatment (up to 8 weeks). Participants were asked to rate their anxiety symptoms during the last seven days on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely) (Aaron T Beck et al., 1988). The BAI is a user-friendly, valid international used inventory, with total scores 0-7 indicating minimal anxiety, 8-15 mild, 16-25 moderate and 26-63 clinical anxiety (Aaron T Beck et al., 1988; Geissner \& Huetteroth, 2018).
Time frame: Baseline and end of inpatient treatment (up to 8 weeks).
Sleep quality during inpatient treatment
Sleep quality was evaluated during the HARMODI study with the German version of the 19-item Pittsburgh Sleep Quality Index (PSQI) (Buysse et al., 1989) at baseline and end of inpatient treatment (up to 8 weeks). A total score \>5 separates between good and poor sleep (Buysse et al., 1989).
Time frame: Baseline and end of inpatient treatment (up to 8 weeks).
Somatic and psychiatric symptoms during inpatient treatment
Somatic and psychiatric symptoms were assessed during the HARMODI study using the German version of the 53-item Brief Symptom Checklist (BSCL) at baseline and end of inpatient treatment (up to 8 weeks). Participants were asked to rate their symptoms during the past seven days on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely), with a higher total score indicating worse symptom severity (Derogatis \& Melisaratos, 1983)
Time frame: Baseline and end of inpatient treatment (up to 8 weeks).
Heart rate variability during inpatient treatment
Heart rate variability (HRV) was assessed during the HARMODI study at baseline and end of inpatient treatment (up to 8 weeks). Particular focus is on RMSSD in ms, a robust parasympathetic nervous system parameter that is less influenced by body movement and breathing (Fouradoulas et al., 2019; Laborde et al., 2017).
Time frame: Baseline and end of inpatient treatment (up to 8 weeks).
Cognitive function tests
Cognitive function was tested with the THINC-it tool during the HARMODI study at baseline and end of inpatient treatment (up to 8 weeks). THINC-it tool consists of a self-rated questionnaire, the Perceived Deficits Questionnaire (PDQ-5) and variants of four cognitive tests: Choice Reaction Time Identification Task (Spotter), the One-Back Test (Symbol Check), Digit Symbol Substitution Test (Codebreaker) and the Trail Making Test-Part B (Trails) (McIntyre et al., 2017).
Time frame: Baseline and end of inpatient treatment (up to 8 weeks).
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