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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05272774
Other study ID # 25 / (1.3) 250000-KP-22-II
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 22, 2022
Est. completion date October 11, 2022

Study information

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

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date October 11, 2022
Est. primary completion date October 11, 2022
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 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.

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 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. Pre-treatment, post-treatment, 3 months follow-up
Secondary 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. Pre-treatment, post-treatment, 3 months follow-up
Secondary 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. Pre-treatment, post-treatment, 3 months follow-up
Secondary 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. Pre-treatment, post-treatment, 3 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, 3 months follow-up
Secondary 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. Pre-treatment, post-treatment, 3 months follow-up
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