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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-13

Study Completion Date

2026-02-28

Brief Summary

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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?

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Detailed Description

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Conditions

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Depressive Disorder Depression, Unipolar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mind-WIN self-help only

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Mind-WIN blended care

Intervention Type OTHER

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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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MindWin blended care

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No