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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05553210
Other study ID # 25 / (1.3) 250000-KP-22-III
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 11, 2022
Est. completion date June 30, 2023

Study information

Verified date September 2022
Source Vilnius University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Lithuania Vilnius University Vilnius

Sponsors (2)

Lead Sponsor Collaborator
Vilnius University Linkoeping University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
Secondary 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. Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
Secondary 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. Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
Secondary 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. Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up
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