Internet-Based Stress Recovery Program for Adolescents

Stress, Psychological Clinical Trial

— FOREST-A  

Official title:

Internet-Based Stress Recovery Program for Adolescents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05688254
• Other study ID #: (1.5 E) 250000-S-646
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: December 2026

Study information

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

Clinical Trial Summary

The study aims to evaluate the efficacy of the internet-based stress recovery program for adolescents.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2026
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Behavioral:
• FOREST-A
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.

Locations

Country	Name	City	State
Lithuania	Vilnius University	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program evaluation questions	Participants will be given questions regarding the usage, general satisfaction, usefulness of the program, and subjective impact on psychological and physical well-being.	Post-treatment (after 4 weeks)
Primary	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.	Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Secondary	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.	Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Secondary	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.	Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Secondary	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.	Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Secondary	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.	Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
Secondary	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.	Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up