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| ID | Type | Description | Link |
|---|---|---|---|
| 03DPS1033B | Other Grant/Funding Number | Federal Ministry of Education and Research |
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| Name | Class |
|---|---|
| Minddistrict GmbH (E-Mental-Health platform) | UNKNOWN |
| Asklepios Fachklinikum Stadtroda GmbH | UNKNOWN |
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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:
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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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 weeks after baseline |
| anxiety symptoms (GAD-7) at 12 weeks |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holger Schulz, Prof. | Universitätsklinikum Hamburg-Eppendorf | Study Director |
| Martin Schumm, Dr. | Asklepios Clinic Stadtroda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asklepios Klinikum Harburg | Hamburg | 21075 | Germany | |||
| Asklepios Fachklinikum Lübben |
IPD will not be shared due to data protection laws.
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| 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. |
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GAD-7 total score: 0-4 (minimal anxiety) 5-9 (mild anxiety) 10-14 (moderate anxiety) 15-21 (severe anxiety) |
| 12 weeks after baseline |
| mental health-related quality of life (KIDSCREEN-10) at 12 weeks | global Health-Related Quality-of-Life (HRQoL) index (T-values) | 12 weeks after baseline |
| psychosocial functioning (SDQ - self-completion) at 12 weeks | total difficulties score (range 0 to 40, higher scores represent more difficulties) | 12 weeks after baseline |
| Avoiding school/training at 12 weeks | number of days absent since baseline | 12 weeks after baseline |
| medication adherence at 12 weeks | report if medication was taken as prescribed (yes or no response) | 12 weeks after baseline |
| 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) | 12 weeks after baseline |
| inpatient treatment psychiatry at 12 weeks | report of inpatient treatment in a psychiatric hospital since baseline (yes or no response) | 12 weeks after baseline |
| 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". | 12 weeks after baseline |
| 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) | 18 weeks after baseline |
| 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) | 18 weeks after baseline |
| 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) | 18 weeks after baseline |
| mental health-related quality of life (KIDSCREEN-10) at 18 weeks | global HRQoL index (T-values) | 18 weeks after baseline |
| psychosocial functioning (SDQ - self-completion) at 18 weeks | total difficulties score (range 0 to 40, higher scores represent more difficulties) | 18 weeks after baseline |
| avoiding school/training at 18 weeks | number of days absent since baseline | 18 weeks after baseline |
| medication adherence at 18 weeks | report if medication was taken as prescribed (yes or no response) | 18 weeks after baseline |
| 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) | 18 weeks after baseline |
| inpatient treatment psychiatry at 18 weeks | report of inpatient treatment in a psychiatry hospital since baseline (yes or no response) | 18 weeks after baseline |
| Lubin |
| Germany |
| Asklepios Fachklinikum Stadtroda | Stadtroda | 07647 | Germany |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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