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)

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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 by the Mind-WIN aftercare module participants get six digital contacts with a psychotherapist.

Study summary

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.

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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?

Eligibility

Primary outcome measure(s)

• depressive symptoms (PHQ-A) at 12 weeks — 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)

Trial sites (3)

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