Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

6 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

143

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Return to Work (RTW)
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Trajectories of work ability
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cardiorespiratory fitness during inpatient treatment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Clinica Holistica Engiadina

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Namir Lababidi, Dipl., Clinica Holistica Engiadina

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

28 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 augustus 2026

Eerst geplaatst (Werkelijk)

11 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

6 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HARMODI Follow-up
  • CHE (Andere identificatie: Clinica Holistica Engiadina)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren