FOREST-A: Internet-Based Stress Recovery Program for Adolescents

Sponsor
Vilnius University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05688254
Collaborator
(none)
300
1
2
44
6.8

Study Details

Study Description

Brief Summary

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

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

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 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 and the control will take care as usual.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)
Primary Purpose:
Treatment
Official Title:
Internet-Based Stress Recovery Program for Adolescents
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

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

No Intervention: Control group

The control group will take care as usual.

Outcome Measures

Primary Outcome Measures

  1. The Recovery Experience Questionnaire [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 Outcome Measures

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

  1. Program evaluation questions [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vilnius University Vilnius Lithuania

Sponsors and Collaborators

  • Vilnius University

Investigators

  • Principal Investigator: Paulina Zelviene, PhD, Vilnius University, Institute of Psychology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vilnius University
ClinicalTrials.gov Identifier:
NCT05688254
Other Study ID Numbers:
  • (1.5 E) 250000-S-646
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
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 20, 2023