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)

NCT07007247 | Enrolling By Invitation

• 2 other identifiers: Mind-Win pilot study03DPS1033B
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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:

• 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?

Conditions

Depressive Disorder; Depression, Unipolar

Keywords

depression; adolescents; aftercare; digital

Outcome Measures

Primary Outcomes (1)

• depressive symptoms (PHQ-A) at 12 weeks

  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)

  12 weeks after baseline

Secondary Outcomes (18)

• 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

• Avoiding school/training at 12 weeks

  12 weeks after baseline

Study Arms (3)

Mind-Win self-help only

EXPERIMENTAL

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.

Other: Mind-WIN self-help only

Mind-Win blended care

EXPERIMENTAL

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.

Other: Mind-WIN blended care

Care-As-Usual

NO INTERVENTION

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).

Interventions

Mind-WIN self-help only 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 self-help only

Mind-WIN blended care 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.

Also known as: MindWin blended care

Mind-Win blended care

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Minddistrict GmbH (E-Mental-Health platform): collaborator
• Asklepios Fachklinikum Stadtroda GmbH: collaborator

Study Sites (3)

Asklepios Klinikum Harburg

Hamburg, 21075, Germany

Location

Asklepios Fachklinikum Lübben

Lubin, Germany

Location

Asklepios Fachklinikum Stadtroda

Stadtroda, 07647, Germany

Location

MeSH Terms

Conditions

Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Holger Schulz, Prof.

  Universitätsklinikum Hamburg-Eppendorf

  STUDY DIRECTOR

• Martin Schumm, Dr.

  Asklepios Clinic Stadtroda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: June 5, 2025
• Study Start: May 13, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)