- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05553210
Internet-Based Stress Recovery Program FOREST+ for Healthcare Workers (FOREST+)
Effects of Intervention Plan on Outcomes of Stress Recovery Program FOREST+ for Healthcare Workers: A Randomized Controlled Trial
Study Overview
Detailed Description
The intervention will be delivered as an internet-based stress recovery program for healthcare workers, comprising of six modules: 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. An intervention plan will be drawn up with the therapist prior to the start of the program, setting the intensity of engagement and the frequency of reminders. During the program, a therapist provides individual feedback on the completed exercises and can also be available on request.
The effect of the intervention will be compared with a control group that will use the program without an intervention plan. The intervention will be delivered in Lithuanian.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vilnius, Lithuania
- Vilnius University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 therapist-guided online stress recovery intervention with an intervention plan.
|
The intervention will be delivered as an internet-based stress recovery intervention consisting of six weekly modules: introduction, psychological detachment, distancing, mastery, control, and keeping the change alive.
Each module consists of a psychoeducational and an exercise component.
During the program, a therapist provides individual feedback on the completed exercises and can also be available on request.
|
|
Experimental: Control group
The control group will get a 6-week therapist-guided online stress recovery intervention without an intervention plan.
The control group will participate in the program at the same time as the intervention group.
|
The intervention will be delivered as an internet-based stress recovery intervention consisting of six weekly modules: introduction, psychological detachment, distancing, mastery, control, and keeping the change alive.
Each module consists of a psychoeducational and an exercise component.
During the program, a therapist provides individual feedback on the completed exercises and can also be available on request.
|
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 (after 6 weeks), 6 months follow-up
|
Changes on stress recovery are measured.
Recovery Experiences Questionnaire (Sonnentag & Fritz, 2007) is a selfreport 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 (after 6 weeks), 6 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change on Perceived Stress Scale
Time Frame: Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
|
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, post-treatment (after 6 weeks), 6 months follow-up
|
|
Change on Patient Health Questionnaire
Time Frame: Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
|
Changes on anxiety and depression symptoms are measured.
Patient Health Questionnaire-4 (PHQ-4, Kroenke et al., 2001) 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 anxiety or depression symptoms.
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Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
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Change on Well-being Index
Time Frame: Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
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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 (after 6 weeks), 6 months follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Evaldas Kazlauskas, Ph.D., Vilnius University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25 / (1.3) 250000-KP-22-III
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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