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Depressive DisorderMindWinPilotNCT07007247

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)

A study testing Mind-WIN self-help only and Mind-WIN blended care in people with Depressive Disorder and Depression, Unipolar, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Depressive Disorder, Depression, Unipolar
What is being tested?
Mind-WIN self-help only and Mind-WIN blended care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesGermany
Study dates
13 May 2025to Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Germany3 sites

  • Asklepios Klinikum Harburg

    Hamburg, 21075

  • Asklepios Fachklinikum Lübben

    Lubin

  • Asklepios Fachklinikum Stadtroda

    Stadtroda, 07647

Other trials in Germany

About this study

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)

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.

Read more

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?
Being tested
Mind-WIN self-help only, Mind-WIN blended care
Keywords
depression, adolescents, aftercare, digital
Medical subject headings
Depressive Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mind-WIN self-help onlyOther

    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 careOther

    Also called MindWin 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 groups in NCT07007247
Study groupRoleWhat they receive
Mind-Win self-help onlyExperimentalParticipants 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.
Receives: Other: Mind-WIN self-help only
Mind-Win blended careExperimentalParticipants 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.
Receives: Other: Mind-WIN blended care
Care-As-UsualNo interventionParticipants 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 12 weeks after baseline

Secondary outcomes (18)

  1. anxiety and depressive symptoms (RCADS-25) at 12 weeks

    Revised Children's Anxiety and Depression Scale (RCADS-25) total depression and anxiety score (range 0 to 75, higher scores represent more symptoms)

    Measured: 12 weeks after baseline

  2. anxiety symptoms (GAD-7) at 12 weeks

    GAD-7 total score:

    0-4 (minimal anxiety) 5-9 (mild anxiety) 10-14 (moderate anxiety) 15-21 (severe anxiety)

    Measured: 12 weeks after baseline

  3. mental health-related quality of life (KIDSCREEN-10) at 12 weeks

    global Health-Related Quality-of-Life (HRQoL) index (T-values)

    Measured: 12 weeks after baseline

  4. psychosocial functioning (SDQ - self-completion) at 12 weeks

    total difficulties score (range 0 to 40, higher scores represent more difficulties)

    Measured: 12 weeks after baseline

  5. Avoiding school/training at 12 weeks

    number of days absent since baseline

    Measured: 12 weeks after baseline

  6. medication adherence at 12 weeks

    report if medication was taken as prescribed (yes or no response)

    Measured: 12 weeks after baseline

  7. transfer knowledge from psychiatry treatment baseline at 12 weeks

    level of transfer knowledge from psychiatry since baseline (score between 0 and 4, higher score represents higher transfer)

    Measured: 12 weeks after baseline

  8. inpatient treatment psychiatry at 12 weeks

    report of inpatient treatment in a psychiatric hospital since baseline (yes or no response)

    Measured: 12 weeks after baseline

  9. ZUF-8 at 12 weeks (only Intervention groups)

    total score ZUF-8 (indicating patients satisfaction): high scale values indicate high "satisfaction", low scale values indicate low "satisfaction".

    Measured: 12 weeks after baseline

  10. depressive symptoms (PHQ-A) at 18 weeks

    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)

    Measured: 18 weeks after baseline

  11. anxiety and depressive symptoms (RCADS-25) at 18 weeks

    RCADS-25 total depression and anxiety score (range 0 to 75, higher scores represent more symptoms)

    Measured: 18 weeks after baseline

  12. anxiety symptoms (GAD-7) at 18 weeks

    GAD-7 total score:

    0-4 (minimal anxiety) 5-9 (mild anxiety) 10-14 (moderate anxiety) 15-21 (severe anxiety)

    Measured: 18 weeks after baseline

  13. mental health-related quality of life (KIDSCREEN-10) at 18 weeks

    global HRQoL index (T-values)

    Measured: 18 weeks after baseline

  14. psychosocial functioning (SDQ - self-completion) at 18 weeks

    total difficulties score (range 0 to 40, higher scores represent more difficulties)

    Measured: 18 weeks after baseline

  15. avoiding school/training at 18 weeks

    number of days absent since baseline

    Measured: 18 weeks after baseline

  16. medication adherence at 18 weeks

    report if medication was taken as prescribed (yes or no response)

    Measured: 18 weeks after baseline

  17. transfer knowledge frompsychiatry treatment baseline at 18 weeks

    level of transfer knowledge from psychaitry since baseline (score between 0 and 4, higher score represents higher transfer)

    Measured: 18 weeks after baseline

  18. inpatient treatment psychiatry at 18 weeks

    report of inpatient treatment in a psychiatry hospital since baseline (yes or no response)

    Measured: 18 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2025
  2. Study start13 May 2025
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07007247
Sponsor's protocol ID
Mind-Win pilot study
Other IDs
03DPS1033B
Acronym
MindWinPilot
Status last verified
Jun 2025
First submitted
9 May 2025
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared due to data protection laws.

Questions about this trial

What is this clinical trial studying?

A study testing Mind-WIN self-help only and Mind-WIN blended care in people with Depressive Disorder and Depression, Unipolar, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

depressive symptoms (PHQ-A) at 12 weeks (time frame: 12 weeks after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07007247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.

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