청소년 재발 방지를 위한 디지털 중재 (DigiTIFF)
청소년 재발 방지를 위한 디지털 개입
Some adolescents experience periods of anxiety and/or depression, and some find that these periods return over time. The purpose of this study is to examine whether digital interventions-where individuals work systematically with their own thoughts and feelings during periods when they feel well-can help them maintain well-being for longer.
The study includes adolescents aged 16-19 who have previously experienced episodes of depression and/or anxiety to a degree that led them to seek help (e.g., from a school nurse, general practitioner, health clinic, or child and adolescent mental health service). Through a research app on their smartphones, participants complete tasks and answer questionnaires. The study is fully digital. Some participants meet with a therapist in digital group sessions, while others work independently with the digital content.
We will also examine the cost-benefit aspects of offering such interventions. If the study achieves its goals, digital interventions may eventually become a service offered to adolescents recovering from depression and anxiety.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ragnhild Bø, Ph.D.
- 전화번호: +47 41904595
- 이메일: ragnhild.bo@psykologi.uio.no
연구 장소
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Oslo, 노르웨이
- 모병
- University of Oslo
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연락하다:
- Ragnhild Bø, PhD
- 전화번호: +47 41904595
- 이메일: ragnhild.bo@psykologi.uio.no
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Currently in full or partial remission for a minimum of 2 months from a depressive disorder or an anxiety disorder as defined by self-reported scores on RCADS-47: previous episode(s) of t-score > 65 and current t-score =<65.
- Native or fluent Scandinavian language skills.
- Willingness to take part even when allocated to the non-preferred arm of the trial.
Exclusion Criteria:
- Ongoing depressive disorder, ongoing anxiety disorder as defined by current t-score =<65 on RCADS-47.
- Recent completion of one of the interventions in the two interventional arms.
- no available smartphone.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: App intervention
A transdiagnostic, self-guided CBT app:
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A transdiagnostic, self-guided CBT app, called TankeVirus (literally translated Thought Viruses), consisting of three components:
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실험적: Group intervention
A transdiagnostic, mastery course for groups, delivered weekly in webinar format over three sessions. It includes videos and group discussions. |
Group-based webinar offering psychoeducation based on principles of CBT. |
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간섭 없음: Assessment only
Only assessment will be conducted. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Relapse: Number of participants scoring above the diagnostic cut-off on the PHQ-9 modified for teens during the 12-month follow-up.
기간: From enrollment to the end of follow-up at 12-months.
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To use the PHQ-9 as a diagnostic aid for Major Depressive Disorder:
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From enrollment to the end of follow-up at 12-months.
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Time until relapse; reaching the diagnostic criteria of MDD according to PHQ-9 modified for teens
기간: From enrollment to 12-months follow-up
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Number of days until the diagnostic criteria of MDD as assessed PHQ-9 modified for teens has been reached. - Questions 1 and/or 2 need to be endorsed as a "2" or "3"
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From enrollment to 12-months follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Repetitive negative thinking (RNT-10)
기간: At enrollment, and at 3, 6 and 12 months follow-up
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Assess transdiagnostic repetitive negative thinking |
At enrollment, and at 3, 6 and 12 months follow-up
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Somatic complaints (SSS8)
기간: At enrollment, and at 3, 6, and 12-months follow-up.
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Somatic complaints based on sum score of all items |
At enrollment, and at 3, 6, and 12-months follow-up.
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EPOCH Measure of Adolescent Well-Being
기간: At baseline, 3, 6 and 12-months follow-up.
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A 20-item validated questionnaire (4 items per domain; Engagement, Perseverance, Optimism, Connectedness, Happiness) on a 1-5 Likert scale (1=Almost Never, 5=Almost Always) resulting in domain scores, reflecting strengths in these positive psychological areas crucial for youth well-being. |
At baseline, 3, 6 and 12-months follow-up.
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Health related quality of life
기간: At baseline, 3, 6 and 12-months follow-up.
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EQ-5D-5L will be used to assess five domains of patient reported outcomes and for economic evaluation of the interventions. |
At baseline, 3, 6 and 12-months follow-up.
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Health related quality of life - Visual Analog Scale
기간: At baseline, 3, 6 and 12-months follow-up.
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EQ VAS will be used to assess patient reported outcomes for self-rated health and for economic evaluation of the interventions. |
At baseline, 3, 6 and 12-months follow-up.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Client satisfaction questionnaires (CSQ-I)
기간: At 3 months follow-up.
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The 8-item questionnaire assesses how satisfied the participants are with the interventions, only administrated to those who are in the interventional arms. |
At 3 months follow-up.
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공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .