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

6 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

143

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Suiza
      • Süs, Suiza, 7542
        • Aún no reclutando
        • Clinica Holistica Engiadina
        • Contacto:
      • Süs, Suiza, 7542

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Return to Work (RTW)
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Trajectories of work ability
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Cardiorespiratory fitness during inpatient treatment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Clinica Holistica Engiadina

Colaboradores

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

Investigadores

  • Investigador principal: Namir Lababidi, Dipl., Clinica Holistica Engiadina

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de noviembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

28 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de agosto de 2026

Publicado por primera vez (Actual)

11 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de agosto de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HARMODI Follow-up
  • CHE (Otro identificador: Clinica Holistica Engiadina)

Plan de datos de participantes individuales (IPD)

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INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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