About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Previously participatiom in the HARMODI study (No. 2022-01871)
Completion of inpatient treatment at the Clinica Holistica Engiadina
Disqualifiers
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)
Trial 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
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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).
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).
Other outcomes
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.
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).
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.
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).
Sponsors and contacts
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Clinica Holistica Engiadina
Lead sponsor
University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health
Collaborator