An interventional study of FOREST-A in Stress, Psychological, sponsored by Vilnius University. Completed at 1 site in Lithuania. Open to participants aged 15 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Vilnius University · Not applicable, Interventional, and Treatment
The study aims to evaluate the feasibility and efficacy of the internet-based stress recovery program for adolescents.
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.
806 studies on the registry are indexed under Stress, Psychological; 131 are open to participants now.
This study's enrollment of 82 is close to the median of 84 across 651 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →Vilnius University is the lead sponsor of 61 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
The intervention group will get a 4-week online stress recovery intervention.
Behavioral: FOREST-A
The control group will take care as usual.
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.
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.
Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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.
Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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.
Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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.
Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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.
Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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.
Time frame: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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.
Time frame: Post-treatment (after 4 weeks)
Plan to share: No
Ran from Apr 2023 to primary completion in Jun 2023, 2 months.
Of 444 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 2 months is below that.
Counting every sponsor, half of 456 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Vilnius University