Stress Recovery Program FOREST for Healthcare Staff (FOREST)

January 17, 2023 updated by: Evaldas Kazlauskas, Vilnius University

Stress Recovery Program FOREST for Healthcare Staff: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

208

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:

  • 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

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
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.
Experimental: Intervention group
The intervention group will get a 6-week internet-based stress recovery intervention.
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.
Pre-treatment, after 6 weeks, 3 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-treatment, after 6 weeks, 3 months post-treatment
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.
Pre-treatment, after 6 weeks, 3 months post-treatment
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.
Pre-treatment, after 6 weeks, 3 months post-treatment
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.
Pre-treatment, after 6 weeks, 3 months post-treatment
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.
Pre-treatment, after 6 weeks, 3 months post-treatment

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

April 22, 2021

Primary Completion (Actual)

April 22, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

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

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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