Digital Interventions for Relapse Prevention in Adolescence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 495
- 试验地点
- 1
- 主要终点
- Relapse: Number of participants scoring above the diagnostic cut-off on the PHQ-9 modified for teens during the 12-month follow-up.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 =<
- •Native or fluent Scandinavian language skills.
- •Willingness to take part even when allocated to the non-preferred arm of the trial.
排除标准
- •Ongoing depressive disorder, ongoing anxiety disorder as defined by current t-score =<65 on RCADS-
- •Recent completion of one of the interventions in the two interventional arms.
- •no available smartphone.
研究组 & 干预措施
App intervention
A transdiagnostic, self-guided CBT app:
- Standardized self-assessment for mental health: 'Test your psychological immune system'.
- 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 (psychological vitamins).
- Daily practice: Over 20 days, users receive a short, 1-2-minute video each morning. These videos provide practical tips, small experiments, or simple tasks designed to help users integrate healthier coping strategies into their daily lives.
干预措施: Transdiagnostic app intervention (Behavioral)
Group intervention
A transdiagnostic, mastery course for groups, delivered weekly in webinar format over three sessions. It includes videos and group discussions.
干预措施: Transdiagnostic mastery course (Behavioral)
Assessment only
Only assessment will be conducted.
结局指标
主要结局
Relapse: Number of participants scoring above the diagnostic cut-off on the PHQ-9 modified for teens during the 12-month follow-up.
时间窗: From enrollment to the end of follow-up at 12-months.
To use the PHQ-9 as a diagnostic aid for Major Depressive Disorder: * Questions 1 and/or 2 need to be endorsed as a "2" or "3" * Need five or more positive symptoms (positive is defined by a "2" or "3" in questions 1-8 and "1", "2", or "3" in question 9). * The functional impairment question (How difficult….) needs to be rated at least as "somewhat difficult."
Time until relapse; reaching the diagnostic criteria of MDD according to PHQ-9 modified for teens
时间窗: From enrollment to 12-months follow-up
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" * Need five or more positive symptoms (positive is defined by a "2" or "3" in questions 1-8 and by a "1", "2", or "3" in question 9). * The functional impairment question (How difficult….) needs to be rated at least as "somewhat difficult."
次要结局
- Repetitive negative thinking (RNT-10)(At enrollment, and at 3, 6 and 12 months follow-up)
- Somatic complaints (SSS8)(At enrollment, and at 3, 6, and 12-months follow-up.)
- EPOCH Measure of Adolescent Well-Being(At baseline, 3, 6 and 12-months follow-up.)
- Health related quality of life(At baseline, 3, 6 and 12-months follow-up.)
- Health related quality of life - Visual Analog Scale(At baseline, 3, 6 and 12-months follow-up.)
研究者
Ragnhild Bø
Researcher
University of Oslo