Development and Evaluation of a Digital Aftercare Program for Adolescents (12-17 Years) With Depressive Symptoms After Hospital Discharge (Mind-WIN Pilot Study) (Mind-WIN Pilot)

Официальное название

Development and Evaluation of a Digital Aftercare Program for Adolescents (12-17 Years) With Depressive Symptoms After Hospital Discharge (Mind-WIN Pilot Study)

Обзор

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: 1. 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?

Вмешательства

• Другое Mind-WIN self-help only
  The program lets participants work through the module content at their own speed. Part of the program involves keeping an online diary every two weeks to track symptoms. The results are categorized as mild, moderate, or severe depression. If participants have severe symptoms, the recommendation is to get professional help. If participants are taking medication to improve their depression, they can also use the online diary to track their mood and medication
• Другое Mind-WIN blended care
  The program lets participants work through the module content at their own speed. Part of the program involves keeping an online diary every two weeks to track symptoms. The results are categorized as mild, moderate, or severe depression. If participants have severe symptoms, the recommendation is to get professional help. If participants are taking medication to improve their depression, they can also use the online diary to track their mood and medication. In addition to the content provided b

Первичные конечные точки

• depressive symptoms (PHQ-A) at 12 weeks [Срок оценки: 12 weeks after baseline]

Вторичные конечные точки (12)

• anxiety and depressive symptoms (RCADS-25) at 12 weeks [Срок оценки: 12 weeks after baseline]
• anxiety symptoms (GAD-7) at 12 weeks [Срок оценки: 12 weeks after baseline]
• mental health-related quality of life (KIDSCREEN-10) at 12 weeks [Срок оценки: 12 weeks after baseline]
• psychosocial functioning (SDQ - self-completion) at 12 weeks [Срок оценки: 12 weeks after baseline]
• Avoiding school/training at 12 weeks [Срок оценки: 12 weeks after baseline]
• medication adherence at 12 weeks [Срок оценки: 12 weeks after baseline]
• transfer knowledge from psychiatry treatment baseline at 12 weeks [Срок оценки: 12 weeks after baseline]
• inpatient treatment psychiatry at 12 weeks [Срок оценки: 12 weeks after baseline]
• ZUF-8 at 12 weeks (only Intervention groups) [Срок оценки: 12 weeks after baseline]
• depressive symptoms (PHQ-A) at 18 weeks [Срок оценки: 18 weeks after baseline]
• anxiety and depressive symptoms (RCADS-25) at 18 weeks [Срок оценки: 18 weeks after baseline]
• anxiety symptoms (GAD-7) at 18 weeks [Срок оценки: 18 weeks after baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Германия · 3 центра

• Asklepios Klinikum Harburg — Hamburg
• Asklepios Fachklinikum Lübben — Lubin
• Asklepios Fachklinikum Stadtroda — Stadtroda

Идентификаторы

NCT: NCT07007247 · Mind-Win pilot study · 03DPS1033B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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