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

NCT07757997 | Recruiting DMC

• 2 other identifiers: HARMODI Follow-upCHE
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Depression - Major Depressive Disorder; Adjustment Disorder; Burnout Syndrome

Keywords

Depression; Burnout; Return to Work; long-term treatment effects; work ability; mental health

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Retrospective rating at follow-up: work ability from one up to 25 months after discharge from the clinic

• Work ability at follow-up

  Up to three years after discharge

• Symptom burden at follow-up

  Up to three years after discharge

• Sleep quality at follow-up

  Up to three years after discharge

• Physical activity at follow-up

  Up to three years after discharge

Other Outcomes (8)

• Cardiorespiratory fitness during inpatient treatment

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

• Exhaustion during inpatient treatment

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

• Depression during inpatient treatment

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinica Holistica Engiadina: lead
• University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health: collaborator

Study Sites (2)

Clinica Holistica Engiadina

Süs, 7542, Switzerland

NOT YET RECRUITING

Clinica Holistica Engiadina

Süs, 7542, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 38925684 BACKGROUND

MeSH Terms

Conditions

Adjustment Disorders; Burnout, Psychological; Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Namir Lababidi, Dipl.

  Clinica Holistica Engiadina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wiebke Turner, MoA

CONTACT

0813002030; wiebke.turner@clinica-holistica.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-07

Locations

CH (2)