Clinical trial NCT07007247: 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)
Official title: Development and Evaluation of a Digital Aftercare Program for Adolescents (12-17 Years) With Depressive Symptoms After Hospital Discharge (Mind-WIN Pilot Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive Disorder
Depression, Unipolar
Keywords: depression
adolescents
aftercare
digital
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Minddistrict GmbH (E-Mental-Health platform)
name: Asklepios Fachklinikum Stadtroda GmbH
First posted: 2025-06-05
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: depressive symptoms (PHQ-A) at 12 weeks
timeFrame: 12 weeks after baseline
Secondary outcomes:
measure: anxiety and depressive symptoms (RCADS-25) at 12 weeks
timeFrame: 12 weeks after baseline
measure: anxiety symptoms (GAD-7) at 12 weeks
timeFrame: 12 weeks after baseline
measure: mental health-related quality of life (KIDSCREEN-10) at 12 weeks
timeFrame: 12 weeks after baseline
measure: psychosocial functioning (SDQ - self-completion) at 12 weeks
timeFrame: 12 weeks after baseline
measure: Avoiding school/training at 12 weeks
timeFrame: 12 weeks after baseline
measure: medication adherence at 12 weeks
timeFrame: 12 weeks after baseline
measure: transfer knowledge from psychiatry treatment baseline at 12 weeks
timeFrame: 12 weeks after baseline
measure: inpatient treatment psychiatry at 12 weeks
timeFrame: 12 weeks after baseline
measure: ZUF-8 at 12 weeks (only Intervention groups)
timeFrame: 12 weeks after baseline
measure: depressive symptoms (PHQ-A) at 18 weeks
timeFrame: 18 weeks after baseline
measure: anxiety and depressive symptoms (RCADS-25) at 18 weeks
timeFrame: 18 weeks after baseline
measure: anxiety symptoms (GAD-7) at 18 weeks
timeFrame: 18 weeks after baseline
measure: mental health-related quality of life (KIDSCREEN-10) at 18 weeks
timeFrame: 18 weeks after baseline
measure: psychosocial functioning (SDQ - self-completion) at 18 weeks
timeFrame: 18 weeks after baseline
measure: avoiding school/training at 18 weeks
timeFrame: 18 weeks after baseline
measure: medication adherence at 18 weeks
timeFrame: 18 weeks after baseline
measure: transfer knowledge frompsychiatry treatment baseline at 18 weeks
timeFrame: 18 weeks after baseline
measure: inpatient treatment psychiatry at 18 weeks
timeFrame: 18 weeks after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Holger Schulz, Prof.
role: STUDY_DIRECTOR
affiliation: Asklepios Clinic Stadtroda
name: Martin Schumm, Dr.
role: PRINCIPAL_INVESTIGATOR
References: