NCT05272774

Brief Summary

The aim of the study is to assess the efficacy of an online stress recovery intervention for healthcare workers receiving therapist-assisted or on-demand support.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

March 22, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2022

Completed
Last Updated

January 25, 2023

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

February 17, 2022

Last Update Submit

January 24, 2023

Conditions

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 consisting of 16 questions. All items are answered on a 5-point Likert scale ranging from 1 (Totally disagree) to 5 (Totally agree). A higher score indicates more pronounced recovery.

    Pre-treatment, post-treatment, 3 months follow-up

Secondary Outcomes (5)

  • Change on Perceived Stress Scale

    Pre-treatment, post-treatment, 3 months follow-up

  • Change on Patient Health Questionnaire

    Pre-treatment, post-treatment, 3 months follow-up

  • Change on Generalized Anxiety Disorder Questionnaire

    Pre-treatment, post-treatment, 3 months follow-up

  • Change on Well-being Index

    Pre-treatment, post-treatment, 3 months follow-up

  • Change on Moral Injury Outcome Scale

    Pre-treatment, post-treatment, 3 months follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will get a 6-week online stress recovery intervention with the support from therapist.

Behavioral: FOREST+

Control group

EXPERIMENTAL

The control group will use the intervention with on-demand support. The control group will participate in the program at the same time as the intervention group.

Behavioral: FOREST+

Interventions

FOREST+BEHAVIORAL

The intervention will be delivered as an online stress recovery intervention consisting of six weekly modules. Modules include an introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. These modules have been chosen after considering the themes that could be most useful for healthcare workers under high stress. Each module consists of a psychoeducational and an exercise component.

Control groupIntervention group

Eligibility Criteria

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

You may qualify if:

  • licensed healthcare professionals currently working under license;
  • at least 18 years old;
  • comprehending Lithuanian language;
  • access to internet.

You may not qualify if:

  • acute psychiatric crisis;
  • high suicide risk;
  • interpersonal violence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University

Vilnius, Lithuania

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Forests

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

EcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Evaldas Kazlauskas, Ph.D.

    Vilnius University

    PRINCIPAL INVESTIGATOR

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 will use the intervention without feedback from therapist but with support on-demand. The control group will participate in the program at the same time as the intervention group with therapist support.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 9, 2022

Study Start

March 22, 2022

Primary Completion

October 11, 2022

Study Completion

October 11, 2022

Last Updated

January 25, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations