Perceived StressFORESTNCT04817995
Stress Recovery Program FOREST for Healthcare Staff
A study testing FOREST in people with Perceived Stress, run by Vilnius University at 1 site in Lithuania.
Trial summary
The aim of the study is to assess the efficacy of an internet-based stress recovery intervention among healthcare staff during COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perceived Stress
- 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
- 208 participants
- Where
- 1 siteLithuania
- Study dates
- 22 Apr 2021to 31 Dec 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
- at least 18 years old;
- comprehending Lithuanian language;
- access to internet;
- high levels of stress.
Who cannot join
- acute psychiatric crisis;
- high suicide risk;
- interpersonal violence;
- alcohol / drug addiction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Recovery Program FOREST for Healthcare Staff: A Randomized Controlled Trial
The aim of the study is to assess the efficacy of an internet-based stress recovery intervention among healthcare staff during COVID-19 pandemic.
Read the detailed description
Intervention is going to take the form of an internet-based stress recovery intervention consisting of six modules. The themes include introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. These themes were chosen after considering topics that might be the most useful for healthcare staff experiencing high levels of stress. Each module consists of psychoeducation and exercise parts. Psychologist provide individual feedback on completed exercises as well as can be reached on demand.
The effect of the intervention will be compared against a waiting list control group. Intervention is in Lithuanian.
- Conditions
- Perceived Stress
- Being tested
- FOREST
- Keywords
- Healthcare staff, Perceived stress, Internet intervention, Recovery, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FORESTBehavioural
Intervention is going to take the form of an internet-based stress recovery intervention consisting of six modules. The themes include introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. These themes were chosen after considering topics that might be the most useful for healthcare staff experiencing high levels of stress. Each module consists of psychoeducation and exercise parts. Psychologist provide individual feedback on completed exercises as well as can be reached on demand.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will get a 6-week internet-based stress recovery intervention. Receives: Behavioral: FOREST |
| Control group | No intervention | The waiting list will get no intervention while the intervention group is getting the intervention. The waiting list has the possibility to get an intervention after the intervention group finishes it. |
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 and consists of 16 questions. All items are answered on a 5-point Likert scale that ranges from 1 (Totally disagree) to 5 (Totally agree). Higher score indicates more pronounced recovery.
Measured: Pre-treatment, after 6 weeks, 3 months post-treatment
Secondary outcomes (5)
Change on International Trauma Questionnaire
Changes on post-traumatic stress disorder are measured. International Trauma Questionanaire (ITQ, Cloitre et al., 2018) is a self-report measure and consists of 18 questions. All items are answered on a 5-point Likert scale that ranges from 0 (not at all) to 4 (extremely). Higher score indicates more pronounced symptoms.
Measured: Pre-treatment, after 6 weeks, 3 months post-treatment
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, after 6 weeks, 3 months post-treatment
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, after 6 weeks, 3 months post-treatment
Change on Patient Health Questionnaire
Changes on depression and anxiety are measured. Patient Health Questionnaire-4 (PHQ-4, Kroenke et al., 2009) 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 depression and anxiety.
Measured: Pre-treatment, after 6 weeks, 3 months post-treatment
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, after 6 weeks, 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start22 Apr 2021
- Primary completion22 Apr 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perceived StressStudies 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 is a waiting list. The control group will participate in the intervention after it will be completed for the intervention group.
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Evaldas Kazlauskas, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817995
- Sponsor's protocol ID
- 2021-03-22/61
- Acronym
- FOREST
- Status last verified
- Jan 2023
- First submitted
- 23 Mar 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dumarkaite A, Truskauskaite I, Andersson G, Jovarauskaite L, Jovaisiene I, Nomeikaite A, Kazlauskas E. The efficacy of the internet-based stress recovery intervention FOREST for nurses amid the COVID-19 pandemic: A randomized controlled trial. Int J Nurs Stud. 2023 Feb;138:104408. doi: 10.1016/j.ijnurstu.2022.104408. Epub 2022 Nov 24.
PubMed 36527859Jovarauskaite L, Murphy D, Truskauskaite-Kuneviciene I, Dumarkaite A, Andersson G, Kazlauskas E. Associations between moral injury and ICD-11 post-traumatic stress disorder (PTSD) and complex PTSD among help-seeking nurses: a cross-sectional study. BMJ Open. 2022 May 9;12(5):e056289. doi: 10.1136/bmjopen-2021-056289.
PubMed 35534083Jovarauskaite L, Dumarkaite A, Truskauskaite-Kuneviciene I, Jovaisiene I, Andersson G, Kazlauskas E. Internet-based stress recovery intervention FOREST for healthcare staff amid COVID-19 pandemic: study protocol for a randomized controlled trial. Trials. 2021 Aug 21;22(1):559. doi: 10.1186/s13063-021-05512-1.
PubMed 34419114
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Recovery Program FOREST for Healthcare Staff: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04817995
- Acronym / sponsor ID
- FOREST / 2021-03-22/61
- Conditions
- Perceived Stress
- Keywords
- Healthcare staff, Perceived stress, Internet intervention, Recovery, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Mar 2021 (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 internet-based stress recovery intervention among healthcare staff during COVID-19 pandemic.
Detailed description
Intervention is going to take the form of an internet-based stress recovery intervention consisting of six modules. The themes include introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. These themes were chosen after considering topics that might be the most useful for healthcare staff experiencing high levels of stress. Each module consists of psychoeducation and exercise parts. Psychologist provide individual feedback on completed exercises as well as can be reached on demand.
The effect of the intervention will be compared against a waiting list control group. Intervention is 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 is a waiting list. The control group will participate in the intervention after it will be completed for the intervention group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: FORESTThe intervention group will get a 6-week internet-based stress recovery intervention. |
| Control group | No intervention | –The waiting list will get no intervention while the intervention group is getting the intervention. The waiting list has the possibility to get an intervention after the intervention group finishes it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years old;
- comprehending Lithuanian language;
- access to internet;
- high levels of stress.
Key exclusion criteria (4 listed)
- acute psychiatric crisis;
- high suicide risk;
- interpersonal violence;
- alcohol / drug addiction.
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 |
|---|---|---|
| FORESTIntervention is going to take the form of an internet-based stress recovery intervention consisting of six modules. The themes include introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. These themes were chosen after considering topics that might be the most useful for healthcare staff experiencing high levels of stress. Each module consists of psychoeducation and exercise parts. Psychologist provide individual feedback on completed exercises as well as can be reached on demand. | Behavioural | Intervention group |
Primary outcome
Change on Recovery Experience Questionnaire
Time frame: Pre-treatment, after 6 weeks, 3 months post-treatment
Changes on stress recovery are measured. Recovery Experiences Questionnaire (Sonnentag \& Fritz, 2007) is a self-report measure and consists of 16 questions. All items are answered on a 5-point Likert scale that ranges from 1 (Totally disagree) to 5 (Totally agree). Higher score indicates more pronounced recovery.
5 secondary outcomes
Change on International Trauma Questionnaire
Time frame: Pre-treatment, after 6 weeks, 3 months post-treatment
Change on Moral Injury Outcome Scale
Time frame: Pre-treatment, after 6 weeks, 3 months post-treatment
Change on Perceived Stress Scale
Time frame: Pre-treatment, after 6 weeks, 3 months post-treatment
Change on Patient Health Questionnaire
Time frame: Pre-treatment, after 6 weeks, 3 months post-treatment
Change on Well-being Index
Time frame: Pre-treatment, after 6 weeks, 3 months post-treatment
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 18 Jan 2023.
- Derived from this study: PubMed 36527859Dumarkaite A, Truskauskaite I, Andersson G, Jovarauskaite L, Jovaisiene I, Nomeikaite A, Kazlauskas E. The efficacy of the internet-based stress recovery intervention FOREST for nurses amid the COVID-19 pandemic: A randomized controlled trial. Int J Nurs Stud. 2023 Feb;138:104408. doi: 10.1016/j.ijnurstu.2022.104408. Epub 2022 Nov 24.
- Derived from this study: PubMed 35534083Jovarauskaite L, Murphy D, Truskauskaite-Kuneviciene I, Dumarkaite A, Andersson G, Kazlauskas E. Associations between moral injury and ICD-11 post-traumatic stress disorder (PTSD) and complex PTSD among help-seeking nurses: a cross-sectional study. BMJ Open. 2022 May 9;12(5):e056289. doi: 10.1136/bmjopen-2021-056289.
- Derived from this study: PubMed 34419114Jovarauskaite L, Dumarkaite A, Truskauskaite-Kuneviciene I, Jovaisiene I, Andersson G, Kazlauskas E. Internet-based stress recovery intervention FOREST for healthcare staff amid COVID-19 pandemic: study protocol for a randomized controlled trial. Trials. 2021 Aug 21;22(1):559. doi: 10.1186/s13063-021-05512-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Perceived Stress, 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 4 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 18 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, after 6 weeks, 3 months post-treatment). 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 NCT04817995, which also lists 3 linked publications.
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 18 Jan 2023.