Stress Recovery Program FOREST+ for Healthcare Workers (FOREST+)

January 24, 2023 updated by: Vilnius University

Efficacy of the FOREST+ Stress Recovery Program for Healthcare Workers: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The intervention will be delivered as an online stress recovery program for healthcare workers, consisting of six modules. Modules include an introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. These modules have been chosen after considering themes that could be most useful for healthcare workers under high stress. Each module consists of a psychoeducational and an exercise component. During the program, a therapist provides individual feedback on the exercises completed and can also be available on request.

The effect of the intervention will be compared with a control group that will use the program with support on-demand. The intervention will be delivered in Lithuanian.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vilnius, Lithuania
        • Vilnius University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Recovery Experience Questionnaire
Time Frame: Pre-treatment, post-treatment, 3 months follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Perceived Stress Scale
Time Frame: Pre-treatment, post-treatment, 3 months follow-up
Changes on perceived stress are measured. Perceived Stress Scale (PSS-10, Cohen et al., 1983) is a self-report measure and consists of 10 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.
Pre-treatment, post-treatment, 3 months follow-up
Change on Patient Health Questionnaire
Time Frame: Pre-treatment, post-treatment, 3 months follow-up
Changes on depression symptoms are measured. Patient Health Questionnaire-9 (PHQ-9, Kroenke et al., 2001) is a self-report measure and consists of 9 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 symptoms.
Pre-treatment, post-treatment, 3 months follow-up
Change on Generalized Anxiety Disorder Questionnaire
Time Frame: Pre-treatment, post-treatment, 3 months follow-up
Changes on anxiety symptoms are measured. Generalized Anxiety Disorder Questionnaire-7 (GAD-7, Kroenke et al., 2001) is a self-report measure and consists of 7 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 anxiety symptoms.
Pre-treatment, post-treatment, 3 months follow-up
Change on Well-being Index
Time Frame: Pre-treatment, post-treatment, 3 months follow-up
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.
Pre-treatment, post-treatment, 3 months follow-up
Change on Moral Injury Outcome Scale
Time Frame: Pre-treatment, post-treatment, 3 months follow-up
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.
Pre-treatment, post-treatment, 3 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Evaldas Kazlauskas, Ph.D., Vilnius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2022

Primary Completion (Actual)

October 11, 2022

Study Completion (Actual)

October 11, 2022

Study Registration Dates

First Submitted

February 17, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25 / (1.3) 250000-KP-22-II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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