Health and Work Ability Following Inpatient Treatment for Stress-related Disorders - Follow-up Study of the HARMODI Cohort
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Wiebke Turner, MoA
- 电话号码：+41 81 300 26 0813002030
- 邮箱：wiebke.turner@clinica-holistica.ch
学习地点
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Süs、瑞士、7542
- 尚未招聘
- Clinica Holistica Engiadina
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接触：
- Namir Lababidi, Dipl.
- 电话号码：+41 81 300 20 30
- 邮箱：Namir.Lababidi@clinica-holistica.ch
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Süs、瑞士、7542
- 招聘中
- Clinica Holistica Engiadina
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接触：
- Namir Lababidi, Dipl.
- 电话号码：+41 81 300 20 30
- 邮箱：Namir.Lababidi@clinica-holistica.ch
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
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
描述
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)
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Time to Return to Work (RTW)
大体时间：From discharge from inpatient treatment until the first documented partial, respectively full RTW, assessed up to 40 months.
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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.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Trajectories of work ability
大体时间：Retrospective rating at follow-up: work ability from one up to 25 months after discharge from the clinic
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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.
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Retrospective rating at follow-up: work ability from one up to 25 months after discharge from the clinic
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Work ability at follow-up
大体时间：Up to three years after discharge
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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.
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Up to three years after discharge
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Symptom burden at follow-up
大体时间：Up to three years after discharge
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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).
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Up to three years after discharge
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Sleep quality at follow-up
大体时间：Up to three years after discharge
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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).
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Up to three years after discharge
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Physical activity at follow-up
大体时间：Up to three years after discharge
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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.
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Up to three years after discharge
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Resilience at follow-up
大体时间：Up to three years after discharge
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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.
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Up to three years after discharge
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Cardiorespiratory fitness during inpatient treatment
大体时间：Baseline and end of inpatient treatment (up to 8 weeks).
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Cardiorespiratory fitness was assessed during the HARMODI study with the submaximal Åstrand-Ryhming Test to calculate maximal oxygen uptake VO2max in ml/kg/min.
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Baseline and end of inpatient treatment (up to 8 weeks).
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Exhaustion during inpatient treatment
大体时间：Baseline and end of inpatient treatment (up to 8 weeks).
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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).
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Baseline and end of inpatient treatment (up to 8 weeks).
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Depression during inpatient treatment
大体时间：Baseline and end of inpatient treatment (up to 8 weeks).
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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.
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Baseline and end of inpatient treatment (up to 8 weeks).
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Anxiety during inpatient treatment
大体时间：Baseline and end of inpatient treatment (up to 8 weeks).
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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).
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Baseline and end of inpatient treatment (up to 8 weeks).
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Sleep quality during inpatient treatment
大体时间：Baseline and end of inpatient treatment (up to 8 weeks).
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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).
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Baseline and end of inpatient treatment (up to 8 weeks).
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Somatic and psychiatric symptoms during inpatient treatment
大体时间：Baseline and end of inpatient treatment (up to 8 weeks).
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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)
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Baseline and end of inpatient treatment (up to 8 weeks).
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Heart rate variability during inpatient treatment
大体时间：Baseline and end of inpatient treatment (up to 8 weeks).
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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).
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Baseline and end of inpatient treatment (up to 8 weeks).
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Cognitive function tests
大体时间：Baseline and end of inpatient treatment (up to 8 weeks).
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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).
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合作者和调查者
调查人员
- 首席研究员：Namir Lababidi, Dipl.、Clinica Holistica Engiadina
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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