Digital Interventions for Relapse Prevention in Adolescence

Обзор

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.

Вмешательства

• Поведенческое Transdiagnostic app intervention
  A transdiagnostic, self-guided CBT app, called TankeVirus (literally translated Thought Viruses), consisting of three components: 1. Standardized self-assessment for mental health: 'Test your psychological immune system'. 2. Educational mini-series: A 30-minute, entertaining video series that teaches users to build resilience by addressing essential needs like sleep (psychological immune system), recognizing negative thought patterns (thought viruses), and developing healthier coping mechanisms
• Поведенческое Transdiagnostic mastery course
  Group-based webinar offering psychoeducation based on principles of CBT.

Первичные конечные точки

• Relapse: Number of participants scoring above the diagnostic cut-off on the PHQ-9 modified for teens during the 12-month follow-up. [Срок оценки: From enrollment to the end of follow-up at 12-months.]
• Time until relapse; reaching the diagnostic criteria of MDD according to PHQ-9 modified for teens [Срок оценки: From enrollment to 12-months follow-up]

Вторичные конечные точки (5)

• Repetitive negative thinking (RNT-10) [Срок оценки: At enrollment, and at 3, 6 and 12 months follow-up]
• Somatic complaints (SSS8) [Срок оценки: At enrollment, and at 3, 6, and 12-months follow-up.]
• EPOCH Measure of Adolescent Well-Being [Срок оценки: At baseline, 3, 6 and 12-months follow-up.]
• Health related quality of life [Срок оценки: At baseline, 3, 6 and 12-months follow-up.]
• Health related quality of life - Visual Analog Scale [Срок оценки: At baseline, 3, 6 and 12-months follow-up.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Норвегия · 1 центр

• University of Oslo — Oslo

Идентификаторы

NCT: NCT07346911 · 870757

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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