Internet-Based Stress Recovery Program FOREST+ for Healthcare Workers

Sponsor
Vilnius University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05553210
Collaborator
Linkoeping University (Other)
91
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2
29.6
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: FOREST+
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
91 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly allocated either to the intervention or control groups. The intervention group will use the intervention with an intervention plan and the control - without an intervention plan. Both groups will participate in the program at the same time.Participants will be randomly allocated either to the intervention or control groups. The intervention group will use the intervention with an intervention plan and the control - without an intervention plan. Both groups will participate in the program at the same time.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Intervention Plan on Outcomes of Stress Recovery Program FOREST+ for Healthcare Workers: A Randomized Controlled Trial
Actual Study Start Date :
Sep 11, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

The intervention group will get a 6-week therapist-guided online stress recovery intervention with an intervention plan.

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.

Experimental: Control group

The control group will get a 6-week therapist-guided online stress recovery intervention without an intervention plan. The control group will participate in the program at the same time as the intervention group.

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.

Outcome Measures

Primary Outcome Measures

  1. Change on Recovery Experience Questionnaire [Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up]

    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.

Secondary Outcome Measures

  1. Change on Perceived Stress Scale [Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up]

    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.

  2. Change on Patient Health Questionnaire [Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up]

    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.

  3. Change on Well-being Index [Pre-treatment, post-treatment (after 6 weeks), 6 months follow-up]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vilnius University Vilnius Lithuania

Sponsors and Collaborators

  • Vilnius University
  • Linkoeping University

Investigators

  • Principal Investigator: Evaldas Kazlauskas, Ph.D., Vilnius University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vilnius University
ClinicalTrials.gov Identifier:
NCT05553210
Other Study ID Numbers:
  • 25 / (1.3) 250000-KP-22-III
First Posted:
Sep 23, 2022
Last Update Posted:
Jan 4, 2023
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2023