NCT04817995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

April 22, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

March 23, 2021

Last Update Submit

January 17, 2023

Conditions

Perceived Stress

Keywords

Healthcare staffPerceived stressInternet interventionRecoveryEfficacy

Outcome Measures

Primary Outcomes (1)

  • Change on Recovery Experience Questionnaire

    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.

    Pre-treatment, after 6 weeks, 3 months post-treatment

Secondary Outcomes (5)

  • Change on International Trauma Questionnaire

    Pre-treatment, after 6 weeks, 3 months post-treatment

  • Change on Moral Injury Outcome Scale

    Pre-treatment, after 6 weeks, 3 months post-treatment

  • Change on Perceived Stress Scale

    Pre-treatment, after 6 weeks, 3 months post-treatment

  • Change on Patient Health Questionnaire

    Pre-treatment, after 6 weeks, 3 months post-treatment

  • Change on Well-being Index

    Pre-treatment, after 6 weeks, 3 months post-treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will get a 6-week internet-based stress recovery intervention.

Behavioral: FOREST

Control group

NO INTERVENTION

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.

Interventions

FORESTBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years old;
  • comprehending Lithuanian language;
  • access to internet;
  • high levels of stress.

You may not qualify if:

  • acute psychiatric crisis;
  • high suicide risk;
  • interpersonal violence;
  • alcohol / drug addiction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University

Vilnius, Lithuania

Location

Related Publications (3)

  • Dumarkaite A, Truskauskaite I, Andersson G, Jovarauskaite L, Jovaisiene I, Nomeikaite A, Kazlauskas E. The efficacy of the internet-based stress recovery intervention FOREST for nurses amid the COVID-19 pandemic: A randomized controlled trial. Int J Nurs Stud. 2023 Feb;138:104408. doi: 10.1016/j.ijnurstu.2022.104408. Epub 2022 Nov 24.

    PMID: 36527859DERIVED

  • 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.

    PMID: 35534083DERIVED

  • 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.

    PMID: 34419114DERIVED

MeSH Terms

Interventions

Forests

Intervention Hierarchy (Ancestors)

EcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 26, 2021

Study Start

April 22, 2021

Primary Completion

April 22, 2022

Study Completion

December 31, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

LI(1)