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Internet-Based Stress Recovery Program for Adolescents (FOREST-A)

Primary Purpose

Stress, Psychological

Status
Active
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
FOREST-A
Sponsored by
Vilnius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Recent exposure to life-stressor. Students of high schools in Lithuania. Comprehending Lithuanian. Parental and own consent for minor-aged participants (< 18 years)/only own consent for adolescents aged 18 years or older to participate in the study provided. Have access to a device (such as a tablet, phone or computer) with an internet connection. Exclusion Criteria: Acute psychiatric condition/crisis. No recent life-stressor exposure, or low levels of stress.

Sites / Locations

  • Vilnius University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

The intervention group will get a 4-week online stress recovery intervention.

The control group will take care as usual.

Outcomes

Primary Outcome Measures

The Recovery Experience Questionnaire
The Recovery Experience Questionnaire (Sonnentag & Fritz, 2007) adapted Child and Adolescent version will be used to measure the changes in recovery from stress experience. It is a self-report measure comprising 16 items, with provided 5-point Likert scale, ranging from Totally disagree (=1) to Totally agree (=5). Total scores may range from 16 to 80, and higher scores will indicate higher recovery.

Secondary Outcome Measures

The Adjustment Disorder New Module-8 Child and Adolescent Version Questionnaire
The Adjustment Disorder New Module-8 Child and Adolescent Version (Kazlauskas et al., 2018) will be used to measure the changes in symptoms of adjustment disorder, which are described in the International Classification of diseases 11th edition (WHO, 2018). The measure includes a list of 16 potentially stressful events (with binary answers Yes and No, indicating whether the participant has experienced a stressor) and 8 items for adjustment disorder symptoms evaluation (with a 4-point Likert scale ranging from Never (=1) to Often (=4)). Total scores may range from 8 to 32, and higher scores will indicate higher adjustment problems.
The Generalized Anxiety Disorder-7 scale
The Generalized Anxiety Disorder-7 scale (Spitzer, Kroenke, Williams, & Löwe, 2007) will be used to measure the changes in generalized anxiety symptoms.The measure comprises 7 items with the possible answers ranging on a 4-point Likert scale from Not at all (=0) to Nearly every day (=3). Total scores may range from 0 to 21. Higher scores will indicate higher generalized anxiety symptoms.
The Patient Health Questionnaire-9 questionnaire
The Patient Health Questionnaire-9 (Löwe, Kroenke, Herzog, & Gräfe, 2004) will be used to measure changes in depressive symptoms. The measure comprises 9 items, with provided a 4-point Likert scale, ranging from Not at all (=0) to Nearly every day (=3). Total scores may range from 0 to 27. Higher scores will indicate higher depressive symptoms.
The WHO-5 Well-being Index Questionnaire
The WHO-5 Well-being Index (Topp, Østergaard, Søndergaard, & Bech, 2015) will be used to measure changes in general psychological well-being. The measure comprises 5 items with a Likert scale ranging At no time (=0) to All of the time (=5). Total scores may range from 0 to 25. Higher scores will indicate better psychological well-being.
The Perceived Positive Social Support Scale
The Perceived Positive Social Support Scale (Kazlauskas et al., 2022) will be used to measure changes in social support. The measure comprises 4 items, with provided an 8-point Likert scale ranging from Never (=0) to Always (=7). Total scores may range from 0 to 28. Higher scores will indicate higher perceived positive support.

Full Information

First Posted
January 8, 2023
Last Updated
June 1, 2023
Sponsor
Vilnius University
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1. Study Identification

Unique Protocol Identification Number
NCT05688254
Brief Title
Internet-Based Stress Recovery Program for Adolescents
Acronym
FOREST-A
Official Title
Internet-Based Stress Recovery Program for Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vilnius University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study aims to evaluate the efficacy of the internet-based stress recovery program for adolescents.
Detailed Description
The FOREST-A is a third-wave cognitive behavioral therapy and mindfulness-based internet-delivered 4-week psychosocial intervention for recovery from stress, which was initially developed for healthcare workers and is now adapted for adolescents. The program comprises six modules: introduction, relaxation, psychological detachment, mastery, control, and summary, with psychologist engagement on-demand. Each module includes psychoeducation and exercises. The program will be delivered in Lithuanian. The intervention will be evaluated using the two-arm randomized controlled trial with intervention and care as usual condition at pre-test, post-test, and 3-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly allocated either to the intervention or control groups. The intervention group will use the intervention and the control will take care as usual.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group will get a 4-week online stress recovery intervention.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will take care as usual.
Intervention Type
Behavioral
Intervention Name(s)
FOREST-A
Intervention Description
The internet-based psychosocial intervention will be delivered. The intervention comprises six modules: introduction, relaxation, psychological detachment, mastery, control, and summary, within psychoeducation and exercises in each module. The interactions with psychologists will be on demand. The whole intervention duration will be 4 weeks.
Primary Outcome Measure Information:
Title
The Recovery Experience Questionnaire
Description
The Recovery Experience Questionnaire (Sonnentag & Fritz, 2007) adapted Child and Adolescent version will be used to measure the changes in recovery from stress experience. It is a self-report measure comprising 16 items, with provided 5-point Likert scale, ranging from Totally disagree (=1) to Totally agree (=5). Total scores may range from 16 to 80, and higher scores will indicate higher recovery.
Time Frame
Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Secondary Outcome Measure Information:
Title
The Adjustment Disorder New Module-8 Child and Adolescent Version Questionnaire
Description
The Adjustment Disorder New Module-8 Child and Adolescent Version (Kazlauskas et al., 2018) will be used to measure the changes in symptoms of adjustment disorder, which are described in the International Classification of diseases 11th edition (WHO, 2018). The measure includes a list of 16 potentially stressful events (with binary answers Yes and No, indicating whether the participant has experienced a stressor) and 8 items for adjustment disorder symptoms evaluation (with a 4-point Likert scale ranging from Never (=1) to Often (=4)). Total scores may range from 8 to 32, and higher scores will indicate higher adjustment problems.
Time Frame
Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Title
The Generalized Anxiety Disorder-7 scale
Description
The Generalized Anxiety Disorder-7 scale (Spitzer, Kroenke, Williams, & Löwe, 2007) will be used to measure the changes in generalized anxiety symptoms.The measure comprises 7 items with the possible answers ranging on a 4-point Likert scale from Not at all (=0) to Nearly every day (=3). Total scores may range from 0 to 21. Higher scores will indicate higher generalized anxiety symptoms.
Time Frame
Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Title
The Patient Health Questionnaire-9 questionnaire
Description
The Patient Health Questionnaire-9 (Löwe, Kroenke, Herzog, & Gräfe, 2004) will be used to measure changes in depressive symptoms. The measure comprises 9 items, with provided a 4-point Likert scale, ranging from Not at all (=0) to Nearly every day (=3). Total scores may range from 0 to 27. Higher scores will indicate higher depressive symptoms.
Time Frame
Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Title
The WHO-5 Well-being Index Questionnaire
Description
The WHO-5 Well-being Index (Topp, Østergaard, Søndergaard, & Bech, 2015) will be used to measure changes in general psychological well-being. The measure comprises 5 items with a Likert scale ranging At no time (=0) to All of the time (=5). Total scores may range from 0 to 25. Higher scores will indicate better psychological well-being.
Time Frame
Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Title
The Perceived Positive Social Support Scale
Description
The Perceived Positive Social Support Scale (Kazlauskas et al., 2022) will be used to measure changes in social support. The measure comprises 4 items, with provided an 8-point Likert scale ranging from Never (=0) to Always (=7). Total scores may range from 0 to 28. Higher scores will indicate higher perceived positive support.
Time Frame
Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Other Pre-specified Outcome Measures:
Title
Program evaluation questions
Description
Participants will be given questions regarding the usage, general satisfaction, usefulness of the program, and subjective impact on psychological and physical well-being.
Time Frame
Post-treatment (after 4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Recent exposure to life-stressor. Students of high schools in Lithuania. Comprehending Lithuanian. Parental and own consent for minor-aged participants (< 18 years)/only own consent for adolescents aged 18 years or older to participate in the study provided. Have access to a device (such as a tablet, phone or computer) with an internet connection. Exclusion Criteria: Acute psychiatric condition/crisis. No recent life-stressor exposure, or low levels of stress.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulina Zelviene, PhD
Organizational Affiliation
Vilnius University, Institute of Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vilnius University
City
Vilnius
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
No

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Internet-Based Stress Recovery Program for Adolescents

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