Stress Recovery Program FOREST for Healthcare Staff

Perceived Stress Clinical Trial

— FOREST  

Official title:

Stress Recovery Program FOREST for Healthcare Staff: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04817995
• Other study ID #: 2021-03-22/61
• Status: Completed
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 31, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 18 years old;
• comprehending Lithuanian language;
• access to internet;
• high levels of stress.

Exclusion Criteria:

• acute psychiatric crisis;
• high suicide risk;
• interpersonal violence;
• alcohol / drug addiction.

Related Conditions & MeSH terms

• Perceived Stress

Intervention

Behavioral:
• FOREST
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.

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 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.	Pre-treatment, after 6 weeks, 3 months post-treatment
Secondary	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.	Pre-treatment, after 6 weeks, 3 months post-treatment
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, after 6 weeks, 3 months post-treatment
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, after 6 weeks, 3 months post-treatment
Secondary	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.	Pre-treatment, after 6 weeks, 3 months post-treatment
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, after 6 weeks, 3 months post-treatment