- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05688254
청소년을 위한 인터넷 기반 스트레스 회복 프로그램 (FOREST-A)
The study aims to evaluate the feasibility and efficacy of the internet-based stress recovery program for adolescents.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Vilnius, 리투아니아
- Vilnius University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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간섭 없음: Control group
The control group will take care as usual. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Recovery Experience Questionnaire
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Adjustment Disorder New Module-8 Child and Adolescent Version Questionnaire
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Program evaluation questions
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Paulina Zelviene, PhD, Vilnius University, Institute of Psychology
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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