- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04817995
Stress Recovery Program FOREST for Healthcare Staff (FOREST)
Stress Recovery Program FOREST for Healthcare Staff: A Randomized Controlled Trial
Study Overview
Detailed Description
Intervention is going to take the form of an internet-based stress recovery intervention consisting of six modules. The themes include introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. These themes were chosen after considering topics that might be the most useful for healthcare staff experiencing high levels of stress. Each module consists of psychoeducation and exercise parts. Psychologist provide individual feedback on completed exercises as well as can be reached on demand.
The effect of the intervention will be compared against a waiting list control group. Intervention is in Lithuanian.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Vilnius, Lithuania
- Vilnius University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- at least 18 years old;
- comprehending Lithuanian language;
- access to internet;
- high levels of stress.
Exclusion Criteria:
- acute psychiatric crisis;
- high suicide risk;
- interpersonal violence;
- alcohol / drug addiction.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
The waiting list will get no intervention while the intervention group is getting the intervention.
The waiting list has the possibility to get an intervention after the intervention group finishes it.
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Experimental: Intervention group
The intervention group will get a 6-week internet-based stress recovery intervention.
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Intervention is going to take the form of an internet-based stress recovery intervention consisting of six modules.
The themes include introduction, psychological detachment, distancing, mastery, control, and keeping the change alive.
These themes were chosen after considering topics that might be the most useful for healthcare staff experiencing high levels of stress.
Each module consists of psychoeducation and exercise parts.
Psychologist provide individual feedback on completed exercises as well as can be reached on demand.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change on Recovery Experience Questionnaire
Time Frame: Pre-treatment, after 6 weeks, 3 months post-treatment
|
Changes on stress recovery are measured.
Recovery Experiences Questionnaire (Sonnentag & Fritz, 2007) is a self-report measure and consists of 16 questions.
All items are answered on a 5-point Likert scale that ranges from 1 (Totally disagree) to 5 (Totally agree).
Higher score indicates more pronounced recovery.
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Pre-treatment, after 6 weeks, 3 months post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change on International Trauma Questionnaire
Time Frame: Pre-treatment, after 6 weeks, 3 months post-treatment
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Changes on post-traumatic stress disorder are measured.
International Trauma Questionanaire (ITQ, Cloitre et al., 2018) is a self-report measure and consists of 18 questions.
All items are answered on a 5-point Likert scale that ranges from 0 (not at all) to 4 (extremely).
Higher score indicates more pronounced symptoms.
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Pre-treatment, after 6 weeks, 3 months post-treatment
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Change on Moral Injury Outcome Scale
Time Frame: Pre-treatment, after 6 weeks, 3 months post-treatment
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Changes on moral injury are measured.
Moral Injury Outcome Scale (MIOS, Litz et al., 2020) is a self-report measure and consists of 15 questions.
All items are answered on a 5-point Likert scale that ranges from 0 (Strongly disagree) to 4 (Strongly agree).
Higher score indicates more pronounced moral injury.
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Pre-treatment, after 6 weeks, 3 months post-treatment
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Change on Perceived Stress Scale
Time Frame: Pre-treatment, after 6 weeks, 3 months post-treatment
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Changes on perceived stress are measured.
Perceived Stress Scale (PSS-4, Cohen et al., 1983) is a self-report measure and consists of 4 questions.
All items are answered on a 5-point Likert scale that ranges from 0 (Never) to 4 (Very often).
Higher score indicates more pronounced perceived stress.
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Pre-treatment, after 6 weeks, 3 months post-treatment
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Change on Patient Health Questionnaire
Time Frame: Pre-treatment, after 6 weeks, 3 months post-treatment
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Changes on depression and anxiety are measured.
Patient Health Questionnaire-4 (PHQ-4, Kroenke et al., 2009) is a self-report measure and consists of 4 questions.
All items are answered on a 4-point Likert scale that ranges from 0 (Not at all) to 3 (Nearly every day).
Higher score indicates more pronounced depression and anxiety.
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Pre-treatment, after 6 weeks, 3 months post-treatment
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Change on Well-being Index
Time Frame: Pre-treatment, after 6 weeks, 3 months post-treatment
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Changes on well-being are measured.
Well-being Index (WHO-5, Bech, 2004) is a self-report measure and consists of 5 questions.
All items are answered on a 6-point Likert scale that ranges from 0 (At no time) to 5 (All of the time).
Higher score indicates more pronounced well-being.
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Pre-treatment, after 6 weeks, 3 months post-treatment
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Jovarauskaite L, Murphy D, Truskauskaite-Kuneviciene I, Dumarkaite A, Andersson G, Kazlauskas E. Associations between moral injury and ICD-11 post-traumatic stress disorder (PTSD) and complex PTSD among help-seeking nurses: a cross-sectional study. BMJ Open. 2022 May 9;12(5):e056289. doi: 10.1136/bmjopen-2021-056289.
- Jovarauskaite L, Dumarkaite A, Truskauskaite-Kuneviciene I, Jovaisiene I, Andersson G, Kazlauskas E. Internet-based stress recovery intervention FOREST for healthcare staff amid COVID-19 pandemic: study protocol for a randomized controlled trial. Trials. 2021 Aug 21;22(1):559. doi: 10.1186/s13063-021-05512-1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021-03-22/61
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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