Stress Recovery Program FOREST+ for Healthcare Workers

Study Overview
=================
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.

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

Conditions
-----------------
Stress, Psychological

Intervention / Treatment
-----------------
* Behavioral: FOREST+


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention group will get a 6-week online stress recovery intervention with the support from therapist. | Behavioral: FOREST+<br>* 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.<br>|
| Experimental: Control group<br>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+<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-treatment, post-treatment, 3 months follow-up | 
| 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. | Pre-treatment, post-treatment, 3 months follow-up | 
| 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. | Pre-treatment, post-treatment, 3 months follow-up | 
| 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. | Pre-treatment, post-treatment, 3 months follow-up | 
| 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. | Pre-treatment, post-treatment, 3 months follow-up |