- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07620756
Burnout Intervention During War for Hospital Staff in Ukraine
Professional Burnout Among Socially Significant Services in Ukraine in Wartime and Its Dynamics Within the Framework of Training Intervention for Burnout Prevention
Přehled studie
Detailní popis
The investigators will identify eligible participants. An eligibility screening conducted in person or by telephone to ensure the inclusion criteria and to introduce the study is held by the study assistant. All participants must sign an informed consent after written and verbal study clarification. Participants will carry out self-reported measurements at baseline (T0), after the intervention phase of 2-5 days (T1; depending on the date of the second workshop day) and two weeks after finishing the intervention (T2). The group of participants participates in two workshop sessions lasting 2.5-3 hours each and occuring on separate days.
The training is practical in nature and aims to build and/or increase motivation to implement effective strategies for preventing burnout syndrome. Participants learn about scientifically proven methods of supporting mental health and receive tools for applying them in their professional and everyday lives.
The training program covers, in particular, the following areas: managing working time and workload; effective professional communication; developing stress-resistant thinking patterns; forming healthy lifestyle habits; methods of relaxation and overcoming stressful situations. .
The data management plan includes standard procedures for data-handling such as using anonymized identification codes for patient data. The data is being saved in an online database, only allowing researchers involved in the study to access the data.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Solveig Kemna, Dr. med.
- Telefonní číslo: +49 30 450 517 542
- E-mail: solveig.kemna@charite.de
Studijní místa
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Kyiv Oblast
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Kyiv, Kyiv Oblast, Ukrajina, 01601
- Nábor
- National Medical University Bogomolets, Kyiv, Kyiv
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Kontakt:
- Lesia Sak
- Telefonní číslo: (044) 234-92-76
- E-mail: lesia.sak@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Respondents must be 18 years of age or older.
- Sufficient command of the Ukrainian language to understand the materials and complete the questionnaires.
- Voluntary informed consent to participate in the study and data processing.
- Permanent residence in Ukraine at the time of participation in the study.
- Belonging to the working civilian population (medical or non-medical workers).
- Technical ability to participate online (access to the internet and an electronic device for completing questionnaires and participating in training).
- Skills/ability to attend online sessions and use smartphone chat for communication.
- Willingness to complete questionnaires at specified time points (T0, T1, T2).
Exclusion Criteria:
- Inability to provide informed consent or limited legal capacity.
- Presence at the time of inclusion of a condition that significantly complicates participation in the study or adherence to the protocol (acute psychotic episodes, manic states, severe cognitive impairment, decompensated somatic diseases, active dependence on psychoactive substances), Severe mental state or pronounced mental distress requiring urgent specialized care.
- Current intensive psychotherapeutic or psychiatric treatment that may significantly affect the assessed indicators.
- Lack of technical ability to participate in online training or complete questionnaires at specified times.
- Inability to use a smartphone or significant visual, hearing, or speech impairments that prevent interaction with the application and completion of questionnaires.
- Refusal to participate or withdrawal of informed consent at any stage of the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Burnout prevention intervention
The training is practical in nature and aims to build and/or increase motivation to implement effective strategies for preventing burnout syndrome. Participants learn about scientifically proven methods of supporting mental health and receive tools for applying them in their professional and everyday lives. The training program covers, in particular, the following areas: managing working time and workload; effective professional communication; developing stress-resistant thinking patterns; forming healthy lifestyle habits; methods of relaxation and overcoming stressful situations. |
The training is practical in nature and aims to build and/or increase motivation to implement effective strategies for preventing burnout syndrome. Participants learn about scientifically proven methods of supporting mental health and receive tools for applying them in their professional and everyday lives. The training program covers, in particular, the following areas: managing working time and workload; effective professional communication; developing stress-resistant thinking patterns; forming healthy lifestyle habits; methods of relaxation and overcoming stressful situations. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Acceptability of the intervention
Časové okno: Post-Intervention (after completion of 2 workshop sessions; 2-5 weeks from baseline)
|
Feasibility will be indexed by participants attendance of the workshop sessions (>25% of sessions).
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Post-Intervention (after completion of 2 workshop sessions; 2-5 weeks from baseline)
|
|
Feasibility of intervention
Časové okno: Post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline)
|
Feasibility will be indexed by drop-out rate (<50% of participants); dropout is defined as having attended none of the sessions
|
Post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline)
|
|
Acceptability of the intervention
Časové okno: Post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline)
|
Acceptability will be indexed by the retention rate (having filled out the post-intervention questionnaire) of participants to the study (>30% of questionnaires).
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Post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline)
|
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Acceptability of the intervention
Časové okno: Post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline)
|
Acceptability will be assessed by using the Client Satisfaction Questionnaire (Attkisson & Zwick, 1982)
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Post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Stress, anxiety and depression
Časové okno: At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 from baseline), and follow-up (2 weeks after last workshop session)
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The Depression Anxiety Stress Scale (Nilges & Essau, 2015) will be used to analyse symptoms of stress, anxiety and depression.
The main score ranges from 0 to 63, with higher scores indicating higher levels of depressive and anxiety symptoms.
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At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 from baseline), and follow-up (2 weeks after last workshop session)
|
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Resilience
Časové okno: At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 from baseline), and follow-up (2 weeks after last workshop session)
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The Brief Resilience Scale (Smith 2009) will be used to assess the ability to bounce back or recover from stress.
The scale consists of six items rated on a 5-point Likert scale.
For interpretation, a mean score is calculated ranging from 1 to 5, with higher scores indicating greater resilience.
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At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 from baseline), and follow-up (2 weeks after last workshop session)
|
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Traumatic stress
Časové okno: At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline), and follow-up (2 weeks after last workshop session)
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The International Trauma Questionnaire (Cloitre 2018) will be used to assess traumatic stress.
Scores range from 0 to 25, with higher scores indicating greater somatic symptom burden
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At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline), and follow-up (2 weeks after last workshop session)
|
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Burnout - Exhaustion
Časové okno: At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline), and follow-up (2 weeks after last workshop session)
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The Masslach Burnout Inventory (Masslach et al., 1997) will be used to assess burnout, with the domain of emotional exhaustion ranging from 0-54.
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At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline), and follow-up (2 weeks after last workshop session)
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Burnout - Depersonalization
Časové okno: At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline), and follow-up (2 weeks after last workshop session)
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The Masslach Burnout Inventory (Masslach et al., 1997) will be used to assess burnout, with the domain of depersonalization ranging from 0-30.
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At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline), and follow-up (2 weeks after last workshop session)
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Burnout - Personal Accomplishment
Časové okno: At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline), and follow-up (2 weeks after last workshop session)
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The Masslach Burnout Inventory (Masslach et al., 1997) will be used to assess burnout, with the domain of Personal Accomplishment ranging from 0-48.
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At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 days from baseline), and follow-up (2 weeks after last workshop session)
|
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Burnout (custom measure)
Časové okno: At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 from baseline), and follow-up (2 weeks after last workshop session)
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The questionnaire consists of a dichotomous (yes/no) with variable scoring (ranging from 0 to 5) depending on the content of each item. Total score: the overall level of emotional burnout is calculated as the sum of scores across 50 items, with a total score range from 0 to 75. |
At baseline, post-intervention (after completion of 2 workshop sessions; 2-5 from baseline), and follow-up (2 weeks after last workshop session)
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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