Stress, PsychologicalFOREST+NCT05553210
Internet-Based Stress Recovery Program FOREST+ for Healthcare Workers
A study testing FOREST+ in people with Stress, Psychological, run by Vilnius University at 1 site in Lithuania.
Trial summary
The study aims to assess the efficacy of an internet-based stress recovery intervention for healthcare workers receiving therapist support with or without an intervention plan. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- FOREST+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteLithuania
- Study dates
- 11 Sep 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- licensed healthcare professionals currently working under license;
- at least 18 years old;
- comprehending Lithuanian language;
- access to internet.
Who cannot join
- acute psychiatric crisis;
- high suicide risk;
- interpersonal violence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intervention Plan on Outcomes of Stress Recovery Program FOREST+ for Healthcare Workers: A Randomized Controlled Trial
The study aims to assess the efficacy of an internet-based stress recovery intervention for healthcare workers receiving therapist support with or without an intervention plan.
Read the 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.
- Conditions
- Stress, Psychological
- Being tested
- FOREST+
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOREST+Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will get a 6-week therapist-guided online stress recovery intervention with an intervention plan. Receives: Behavioral: FOREST+ |
| Control group | Experimental | 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. Receives: Behavioral: FOREST+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Recovery Experience Questionnaire
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.
Measured: Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
Secondary outcomes (3)
Change on Perceived Stress Scale
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.
Measured: Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
Change on Patient Health Questionnaire
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.
Measured: Pre-treatment, post-treatment (after 6 weeks), 6 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.
Measured: Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start11 Sep 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated either to the intervention or control groups. The intervention group will use the intervention with an intervention plan and the control - without an intervention plan. Both groups will participate in the program at the same time.
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Sponsor
- Investigators
- Evaldas Kazlauskas, Ph.D., Principal investigator, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553210
- Sponsor's protocol ID
- 25 / (1.3) 250000-KP-22-III
- Acronym
- FOREST+
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nomeikaite A, Gelezelyte O, Bottche M, Andersson G, Kazlauskas E. Role of Tailored Timing and Frequency Prompts on the Efficacy of an Internet-Delivered Stress Recovery Intervention for Health Care Workers: Randomized Controlled Trial. JMIR Ment Health. 2025 Jan 28;12:e62782. doi: 10.2196/62782.
PubMed 39874572
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intervention Plan on Outcomes of Stress Recovery Program FOREST+ for Healthcare Workers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05553210
- Acronym / sponsor ID
- FOREST+ / 25 / (1.3) 250000-KP-22-III
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 11 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to assess the efficacy of an internet-based stress recovery intervention for healthcare workers receiving therapist support with or without an intervention plan.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated either to the intervention or control groups. The intervention group will use the intervention with an intervention plan and the control - without an intervention plan. Both groups will participate in the program at the same time.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: FOREST+The intervention group will get a 6-week therapist-guided online stress recovery intervention with an intervention plan. |
| Control group | Experimental | Behavioral: FOREST+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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- licensed healthcare professionals currently working under license;
- at least 18 years old;
- comprehending Lithuanian language;
- access to internet.
Key exclusion criteria (3 listed)
- acute psychiatric crisis;
- high suicide risk;
- interpersonal violence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOREST+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. | Behavioural | Control group, Intervention group |
Primary outcome
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.
3 secondary outcomes
Change on Perceived Stress Scale
Time frame: 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
Change on Well-being Index
Time frame: Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Derived from this study: PubMed 39874572Nomeikaite A, Gelezelyte O, Bottche M, Andersson G, Kazlauskas E. Role of Tailored Timing and Frequency Prompts on the Efficacy of an Internet-Delivered Stress Recovery Intervention for Health Care Workers: Randomized Controlled Trial. JMIR Ment Health. 2025 Jan 28;12:e62782. doi: 10.2196/62782.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evaldas Kazlauskas, Ph.D. principal investigator
Vilnius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOREST+ in people with Stress, Psychological, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on Recovery Experience Questionnaire (time frame: Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05553210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.