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Completed

NCT Number: NCT05688254

Internet-Based Stress Recovery Program for Adolescents

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

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Key information

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vilnius University

Vilnius, Lithuania

About this study

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 and post-test.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FOREST-A

Behavioral

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 outcomes

  1. The Recovery Experience Questionnaire

    Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up

    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 outcomes

  1. The Adjustment Disorder New Module-8 Child and Adolescent Version Questionnaire

    Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up

    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.

  2. The Generalized Anxiety Disorder-7 scale

    Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up

    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.

  3. The Patient Health Questionnaire-9 questionnaire

    Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up

    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.

  4. The WHO-5 Well-being Index Questionnaire

    Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up

    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.

  5. The Perceived Positive Social Support Scale

    Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up

    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.

Other outcomes

  1. Program evaluation questions

    Time frame: Post-treatment (after 4 weeks)

    Participants will be given questions regarding the usage, general satisfaction, usefulness of the program, and subjective impact on psychological and physical well-being.

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Registry information

Acronym: FOREST-A

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2023
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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