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Stress Recovery Program FOREST for Healthcare Staff (FOREST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04817995
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : October 5, 2021
Sponsor:
Collaborator:
Linkoeping University
Information provided by (Responsible Party):
Evaldas Kazlauskas, Vilnius University

Brief Summary:
The aim of the study is to assess the efficacy of an internet-based stress recovery intervention among healthcare staff during COVID-19 pandemic.

Condition or disease Intervention/treatment Phase
Perceived Stress Behavioral: FOREST Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly allocated either to the intervention or control groups. The control group is a waiting list. The control group will participate in the intervention after it will be completed for the intervention group.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stress Recovery Program FOREST for Healthcare Staff: A Randomized Controlled Trial
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Arm Intervention/treatment
Experimental: Intervention group
The intervention group will get a 6-week internet-based stress recovery intervention.
Behavioral: FOREST
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.

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change on International Trauma Questionnaire [ Time Frame: Pre-treatment, after 6 weeks, 3 months post-treatment ]
    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.

  2. Change on Moral Injury Outcome Scale [ Time Frame: Pre-treatment, after 6 weeks, 3 months post-treatment ]
    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.

  3. Change on Perceived Stress Scale [ Time Frame: Pre-treatment, after 6 weeks, 3 months post-treatment ]
    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.

  4. Change on Patient Health Questionnaire [ Time Frame: Pre-treatment, after 6 weeks, 3 months post-treatment ]
    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.

  5. Change on Well-being Index [ Time Frame: Pre-treatment, after 6 weeks, 3 months post-treatment ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04817995


Locations
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Lithuania
Vilnius University Recruiting
Vilnius, Lithuania
Contact: Austeja Dumarkaite, M.A.    +37052686952    austeja.dumarkaite@fsf.vu.lt   
Contact: Evaldas Kazlauskas, Ph.D.    +37052686952    evaldas.kazlauskas@fsf.vu.lt   
Sponsors and Collaborators
Vilnius University
Linkoeping University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Evaldas Kazlauskas, Professor, Vilnius University
ClinicalTrials.gov Identifier: NCT04817995    
Other Study ID Numbers: 2021-03-22/61
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evaldas Kazlauskas, Vilnius University:
Healthcare staff
Perceived stress
Internet intervention
Recovery
Efficacy