Development and Evaluation of a Digital Aftercare Program for Adolescents (12-17 Years) With Depressive Symptoms After Hospital Discharge (Mind-WIN Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- depressive symptoms (PHQ-A) at 12 weeks
研究概览
简要总结
Mind-WIN is a digitally supported (app- and web-based) aftercare program for young people between the ages of 12 and 17, which was developed for adolescent patients with depressive symptoms and is intended to be used after inpatient treatment. The aftercare program includes interactive psychoeducational content and exercises on topics such as daily planning, early warning signs, self-care, and goal setting.
This pilot study will assess the feasibility of the study design and methods. It will also examine the preliminary effectiveness of the Mind-WIN aftercare program on self-reported measures compared to the control group. These outcomes include the levels of depressive symptoms, mental health-related quality of life and psychosocial functioning.
Participants are randomly assigned to one of the three study conditions:
- Mind-WIN self-help only (intervention condition 1): Participants are given access to the Mind-WIN aftercare module. The content is completed in self-study including questions for reflection, quiz questions, videos of an experience expert, and audio exercises.
. 2. Mind-WIN blended care (intervention condition 2): Participants are given access to the Mind-WIN aftercare module and they get additional therapeutic support (video calls to support the young people during module completion, emotional support and therapeutic conversations). 3. Care-As-Usual (waiting control group): Participants have access to standard medical care through the national health insurance system. At the end of the 18-week comparison period, they also have access to the Mind-WIN aftercare module (without therapeutic support).
Researchers will compare the two Mind-WIN intervention groups (Mind-WIN self-help only and Mind-WIN blended care) to care-as-usual (waiting control group) to answer the following questions:
- Is the study design and methods feasible with the target group?
- Is access to the 12-week Mind-WIN aftercare program associated with greater stabilization in the assessed outcomes (at 12 and 18 weeks) compared to standard care?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recently (maximum four weeks ago) discharged from (partial) inpatient treatment in one of the participating Asklepios clinics
- •Age 12 to 17 years
- •Main depressive diagnosis:
- •F32.1 Moderate depressive episode; F32.2 Major depressive episode without psychotic symptoms; F33.1 Recurrent depressive disorder, currently moderate episode; F33.2 Recurrent depressive disorder, currently severe episode without psychotic symptoms
- •Ability to give written consent or assent by persons with custody
- •Access to a smartphone, tablet or computer with internet access
排除标准
- •Mental and behavioural disorders due to psychoactive substance use (ICD-10 codes F10-F19), Schizophrenia, schizotypal and delusional disorders (ICD-10 codes F20-29), major depressive episodes with psychotic symptoms (ICD-10 code F32.3), recurrent depressive disorder, current severe episode with psychotic symptoms (ICD-10 code F33.3)
- •acute suicidality
- •bipolar disorder
研究组 & 干预措施
Mind-Win self-help only
Participants are given access to the Mind-WIN aftercare module. The content is completed in self-study including questions for reflection, quiz questions, videos of an experience expert, and audio exercises.
干预措施: Mind-WIN self-help only (Other)
Mind-Win blended care
Participants are given access to the Mind-WIN aftercare module and they get additional therapeutic support (digital contacts). The content of the MIND-WIN aftercare module is completed in self-study including questions for reflection, quiz questions, videos of an experience expert, and audio exercises.
干预措施: Mind-WIN blended care (Other)
Care-As-Usual
Participants have access to standard medical care through the national health insurance system. After the end of the 18-week comparison period, they also have access to the Mind-WIN self-help module (without therapeutic support).
结局指标
主要结局
depressive symptoms (PHQ-A) at 12 weeks
时间窗: 12 weeks after baseline
Note: As this is a pilot study, no separation into primary and secondary outcomes are formulated at this stage. We define the current primary outcome due to system requirements. PHQ-A total score: 0-4 (minimal depression) 5-9 (mild depression) 10-14 (moderate depression) 15-19 (moderately severe depression) 20-27 (severe depression)
次要结局
- Avoiding school/training at 12 weeks(12 weeks after baseline)
- medication adherence at 18 weeks(18 weeks after baseline)
- transfer knowledge frompsychiatry treatment baseline at 18 weeks(18 weeks after baseline)
- inpatient treatment psychiatry at 18 weeks(18 weeks after baseline)
- psychosocial functioning (SDQ - self-completion) at 18 weeks(18 weeks after baseline)
- avoiding school/training at 18 weeks(18 weeks after baseline)
- anxiety and depressive symptoms (RCADS-25) at 12 weeks(12 weeks after baseline)
- anxiety symptoms (GAD-7) at 12 weeks(12 weeks after baseline)
- mental health-related quality of life (KIDSCREEN-10) at 12 weeks(12 weeks after baseline)
- psychosocial functioning (SDQ - self-completion) at 12 weeks(12 weeks after baseline)
- medication adherence at 12 weeks(12 weeks after baseline)
- transfer knowledge from psychiatry treatment baseline at 12 weeks(12 weeks after baseline)
- inpatient treatment psychiatry at 12 weeks(12 weeks after baseline)
- ZUF-8 at 12 weeks (only Intervention groups)(12 weeks after baseline)
- depressive symptoms (PHQ-A) at 18 weeks(18 weeks after baseline)
- anxiety and depressive symptoms (RCADS-25) at 18 weeks(18 weeks after baseline)
- anxiety symptoms (GAD-7) at 18 weeks(18 weeks after baseline)
- mental health-related quality of life (KIDSCREEN-10) at 18 weeks(18 weeks after baseline)