Stress, PsychologicalFOREST+NCT05272774
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 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. 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
- 220 participants
- Where
- 1 siteLithuania
- Study dates
- 22 Mar 2022to 11 Oct 2022
- 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: Efficacy of the FOREST+ Stress Recovery Program for Healthcare Workers: A Randomized Controlled Trial
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.
Read the 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.
- 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will get a 6-week online stress recovery intervention with the support from therapist. Receives: Behavioral: FOREST+ |
| Control group | Experimental | 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. 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 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.
Measured: Pre-treatment, post-treatment, 3 months follow-up
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-treatment, post-treatment, 3 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 posted9 Mar 2022
- Study start22 Mar 2022
- Primary completion11 Oct 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 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)
- Enrolment
- 220 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
- NCT05272774
- Sponsor's protocol ID
- 25 / (1.3) 250000-KP-22-II
- Acronym
- FOREST+
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the FOREST+ Stress Recovery Program for Healthcare Workers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05272774
- Acronym / sponsor ID
- FOREST+ / 25 / (1.3) 250000-KP-22-II
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 9 Mar 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 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.
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 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: FOREST+The intervention group will get a 6-week online stress recovery intervention with the support from therapist. |
| Control group | Experimental | Behavioral: FOREST+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. |
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 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. | Behavioural | Control group, Intervention group |
Primary outcome
Change on Recovery Experience Questionnaire
Time frame: Pre-treatment, post-treatment, 3 months follow-up
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.
5 secondary outcomes
Change on Perceived Stress Scale
Time frame: Pre-treatment, post-treatment, 3 months follow-up
Change on Patient Health Questionnaire
Time frame: Pre-treatment, post-treatment, 3 months follow-up
Change on Generalized Anxiety Disorder Questionnaire
Time frame: Pre-treatment, post-treatment, 3 months follow-up
Change on Well-being Index
Time frame: Pre-treatment, post-treatment, 3 months follow-up
Change on Moral Injury Outcome Scale
Time frame: Pre-treatment, post-treatment, 3 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 25 Jan 2023.
- 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 25 Jan 2023. 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, 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2023.