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

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
FOREST+
Sponsored by
Vilnius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Vilnius University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change on Perceived Stress Scale
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.
Change on Patient Health Questionnaire
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.
Change on Generalized Anxiety Disorder Questionnaire
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.
Change on Well-being Index
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.
Change on Moral Injury Outcome Scale
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.

Full Information

First Posted
February 17, 2022
Last Updated
January 24, 2023
Sponsor
Vilnius University
Collaborators
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT05272774
Brief Title
Stress Recovery Program FOREST+ for Healthcare Workers
Acronym
FOREST+
Official Title
Efficacy of the FOREST+ Stress Recovery Program for Healthcare Workers: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
October 11, 2022 (Actual)
Study Completion Date
October 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vilnius University
Collaborators
Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group will get a 6-week online stress recovery intervention with the support from therapist.
Arm Title
Control group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
FOREST+
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change on Recovery Experience Questionnaire
Description
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.
Time Frame
Pre-treatment, post-treatment, 3 months follow-up
Secondary Outcome Measure Information:
Title
Change on Perceived Stress Scale
Description
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.
Time Frame
Pre-treatment, post-treatment, 3 months follow-up
Title
Change on Patient Health Questionnaire
Description
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.
Time Frame
Pre-treatment, post-treatment, 3 months follow-up
Title
Change on Generalized Anxiety Disorder Questionnaire
Description
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.
Time Frame
Pre-treatment, post-treatment, 3 months follow-up
Title
Change on Well-being Index
Description
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.
Time Frame
Pre-treatment, post-treatment, 3 months follow-up
Title
Change on Moral Injury Outcome Scale
Description
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.
Time Frame
Pre-treatment, post-treatment, 3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evaldas Kazlauskas, Ph.D.
Organizational Affiliation
Vilnius University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vilnius University
City
Vilnius
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
No

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Stress Recovery Program FOREST+ for Healthcare Workers

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