思春期における再発予防のためのデジタル介入 (DigiTIFF)
青年期における再発予防のためのデジタル介入
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ragnhild Bø, Ph.D.
- 電話番号：+47 41904595
- メール：ragnhild.bo@psykologi.uio.no
研究場所
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Oslo、ノルウェー
- 募集
- University of Oslo
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コンタクト：
- Ragnhild Bø, PhD
- 電話番号：+47 41904595
- メール：ragnhild.bo@psykologi.uio.no
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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介入なし：Assessment only
Only assessment will be conducted. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Repetitive negative thinking (RNT-10)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Client satisfaction questionnaires (CSQ-I)
時間枠：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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協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。