- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05688254
Op internet gebaseerd programma voor stressherstel voor adolescenten (FOREST-A)
The study aims to evaluate the feasibility and efficacy of the internet-based stress recovery program for adolescents.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Vilnius, Litouwen
- Vilnius University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Intervention group
The intervention group will get a 4-week online stress recovery intervention. |
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. |
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Geen tussenkomst: Control group
The control group will take care as usual. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The Recovery Experience Questionnaire
Tijdsspanne: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The Adjustment Disorder New Module-8 Child and Adolescent Version Questionnaire
Tijdsspanne: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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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
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The Generalized Anxiety Disorder-7 scale
Tijdsspanne: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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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
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The Patient Health Questionnaire-9 questionnaire
Tijdsspanne: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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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
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The WHO-5 Well-being Index Questionnaire
Tijdsspanne: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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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
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The Perceived Positive Social Support Scale
Tijdsspanne: Pre-treatment, post-treatment (after 4 weeks), 3 months follow-up
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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
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Program evaluation questions
Tijdsspanne: Post-treatment (after 4 weeks)
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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)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Paulina Zelviene, PhD, Vilnius University, Institute of Psychology
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- (1.5 E) 250000-S-646
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
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