NCT Number: NCT07808762
The aim of the study is to assess the feasibility of implementing the internet-delivered stress recovery intervention FOREST for healthcare staff in a real-world healthcare setting and to obtain preliminary estimates of changes in stress recovery and mental health outcomes.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
The feasibility of implementing the evidence-based, internet-delivered stress recovery intervention FOREST for healthcare staff in a real-world healthcare setting will be evaluated using a single-arm pre-post study design. The study aims to assess the feasibility of implementing the intervention within a hospital setting and to obtain preliminary estimates of changes in stress recovery and mental health outcomes to inform broader implementation across healthcare settings. Information about the intervention and the study will be disseminated within participating healthcare settings. Interested healthcare staff will complete an online eligibility screening. Individuals who meet the inclusion criteria will be invited to provide informed consent and complete the baseline assessment before being enrolled in and granted access to the FOREST intervention.
The FOREST intervention consists of six sessions (Introduction, Psychological Detachment, Distancing, Mastery, Control, and Keeping the Change Alive) delivered over a four-week period. Each session includes psychoeducational content presented through text and video materials, as well as practical stress recovery exercises. Participants will also have access to support from a trained psychologist on demand throughout the intervention.
Assessments will be conducted at baseline, immediately after the four-week intervention, and at a 12-week follow-up after baseline. The study's primary outcomes will assess implementation at the individual level, guided by Proctor et al.'s Implementation Outcomes Framework to evaluate acceptability and appropriateness, alongside intervention uptake (initiation), and complemented by feasibility and process indicators capturing reach, recruitment, engagement, and retention. Secondary outcomes will provide preliminary estimates of changes in stress recovery and other mental health outcomes.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No additional exclusion criteria will be applied in order to maximize inclusiveness and reflect real-world implementation.
The internet-delivered stress recovery intervention FOREST consists of six sessions (Introduction, Psychological Detachment, Distancing, Mastery, Control, and Keeping the Change Alive) delivered over a four-week period. Each session includes psychoeducational content presented through text and video materials, as well as practical stress recovery exercises. Participants also have access to support from a trained psychologist on demand throughout the intervention.
Time frame: Through completion of recruitment, up to 9 months.
Measurement: study recruitment records.
Reach will be assessed as the proportion of the target healthcare workforce that enrolls in the intervention. It will be calculated as the number of enrolled participants divided by the estimated number of healthcare staff in the target workforce, expressed as a percentage.
Time frame: Through completion of recruitment, up to 9 months.
Measurement: Study screening, eligibility, and informed consent records.
Recruitment will be assessed as the number and proportion of eligible healthcare staff who provide informed consent and enroll in the study.
Time frame: Through completion of the intervention period, up to 10 months.
Measurement: FOREST intervention platform usage records.
Intervention uptake will be assessed as the number and proportion of enrolled participants who initiate the intervention by completing the first FOREST session.
Time frame: Through completion of the intervention period, up to 10 months.
Number of intervention sessions completed will be assessed using FOREST intervention platform usage records. The number of FOREST intervention sessions completed by each participant will be recorded.
Time frame: Through completion of the intervention period, up to 10 months.
Percentage of participants completing all six FOREST intervention sessions will be assessed using FOREST intervention platform usage records. The percentage of participants who complete all six FOREST intervention sessions will be calculated as the number of participants completing all six sessions divided by the total number of participants who initiated the intervention, multiplied by 100.
Time frame: Through completion of the 12-week follow-up, up to 12 months.
Measurement: Study assessment completion records.
Retention will be assessed as the number and proportion of enrolled participants who complete the post-intervention assessment and the 12-week follow-up assessment.
Unit of Measure: Number and percentage of participants completing each assessment time point.
Time frame: Through completion of the post-intervention assessment period, up to 10 months.
Measurement: Post-intervention acceptability questions developed by study researchers.
Acceptability will be assessed using post-intervention participant questions evaluating satisfaction with the FOREST intervention, perceived usefulness, and likelihood of recommending the intervention to colleagues. Each item will be reported according to its response scale, with descriptive summary statistics presented for participant responses. Higher scores indicate more pronounced acceptability.
Time frame: Post-intervention assessment, up to 10 months.
Measurement: Post-intervention appropriateness question developed by study researchers.
Appropriateness will be assessed using a post-intervention participant question evaluating participants' perceptions of whether the FOREST intervention is relevant and suitable for healthcare staff working in a hospital setting. The item will be reported according to its response scale, with descriptive summary statistics presented for participant responses. A higher score indicates more pronounced appropriateness.
Time frame: Baseline, post-test after four weeks, follow-up after 12 weeks
Changes in stress recovery are measured. The 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 stress recovery.
Time frame: Baseline, post-test after four weeks, follow-up after 12 weeks
Changes in perceived stress are measured. Perceived Stress Scale (PSS-4, Cohen et al., 1983) is a self-report measure consisting of four questions. All items are answered on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A higher score indicates more pronounced perceived stress.
Time frame: Baseline, post-test after four weeks, follow-up after 12 weeks
Changes in symptoms of anxiety and depression are measured. The Patient Health Questionnaire-4 (PHQ-4; Kroenke et al., 2009) is a self-report measure consisting of four questions. All items are answered on a 4-point Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A higher score indicates more pronounced symptoms of anxiety and depression.
Time frame: Baseline, post-test after four weeks, follow-up after 12 weeks
Changes in mental well-being are measured. Well-being Index (WHO-5, Bech, 2004) is a self-report measure consisting of five questions. All items are answered on a 6-point Likert scale ranging from 0 (At no time) to 5 (All of the time). A higher score indicates more pronounced mental well-being.
Contact information is provided by the study sponsor or research team.
Austeja Dumarkaite, PhD
CONTACT
Evaldas Kazlauskas, PhD
CONTACT
Vilnius University
Other
Acronym: FOREST-IN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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