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Health and Work Ability Following Inpatient Treatment for Stress-related Disorders - Follow-up Study of the HARMODI Cohort

6. srpna 2026 aktualizováno: Clinica Holistica Engiadina
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.

Přehled studie

Postavení

Nábor

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

143

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

Inclusion Criteria:

  • Previously participatiom in the HARMODI study (No. 2022-01871)
  • Completion of inpatient treatment at the Clinica Holistica Engiadina

Exclusion Criteria:

  • 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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to Return to Work (RTW)
Časové okno: 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.
From discharge from inpatient treatment until the first documented partial, respectively full RTW, assessed up to 40 months.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Trajectories of work ability
Časové okno: Retrospective rating at follow-up: work ability from one up to 25 months after discharge from the clinic
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.
Retrospective rating at follow-up: work ability from one up to 25 months after discharge from the clinic
Work ability at follow-up
Časové okno: Up to three years after discharge
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.
Up to three years after discharge
Symptom burden at follow-up
Časové okno: Up to three years after discharge
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).
Up to three years after discharge
Sleep quality at follow-up
Časové okno: Up to three years after discharge
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).
Up to three years after discharge
Physical activity at follow-up
Časové okno: Up to three years after discharge
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.
Up to three years after discharge
Resilience at follow-up
Časové okno: Up to three years after discharge
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.
Up to three years after discharge

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cardiorespiratory fitness during inpatient treatment
Časové okno: Baseline and end of inpatient treatment (up to 8 weeks).
Cardiorespiratory fitness was assessed during the HARMODI study with the submaximal Åstrand-Ryhming Test to calculate maximal oxygen uptake VO2max in ml/kg/min.
Baseline and end of inpatient treatment (up to 8 weeks).
Exhaustion during inpatient treatment
Časové okno: Baseline and end of inpatient treatment (up to 8 weeks).
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).
Baseline and end of inpatient treatment (up to 8 weeks).
Depression during inpatient treatment
Časové okno: Baseline and end of inpatient treatment (up to 8 weeks).
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.
Baseline and end of inpatient treatment (up to 8 weeks).
Anxiety during inpatient treatment
Časové okno: Baseline and end of inpatient treatment (up to 8 weeks).
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).
Baseline and end of inpatient treatment (up to 8 weeks).
Sleep quality during inpatient treatment
Časové okno: Baseline and end of inpatient treatment (up to 8 weeks).
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).
Baseline and end of inpatient treatment (up to 8 weeks).
Somatic and psychiatric symptoms during inpatient treatment
Časové okno: Baseline and end of inpatient treatment (up to 8 weeks).
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)
Baseline and end of inpatient treatment (up to 8 weeks).
Heart rate variability during inpatient treatment
Časové okno: Baseline and end of inpatient treatment (up to 8 weeks).
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).
Baseline and end of inpatient treatment (up to 8 weeks).
Cognitive function tests
Časové okno: Baseline and end of inpatient treatment (up to 8 weeks).

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).
Baseline and end of inpatient treatment (up to 8 weeks).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Clinica Holistica Engiadina

Spolupracovníci

University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health

Vyšetřovatelé

  • Vrchní vyšetřovatel: Namir Lababidi, Dipl., Clinica Holistica Engiadina

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

1. listopadu 2026

Dokončení studie (Odhadovaný)

1. prosince 2026

Termíny zápisu do studia

První předloženo

28. července 2026

První předloženo, které splnilo kritéria kontroly kvality

6. srpna 2026

První zveřejněno (Aktuální)

11. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. srpna 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • HARMODI Follow-up
  • CHE (Jiný identifikátor: Clinica Holistica Engiadina)

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