Depression, Unipolar, Depressive Disorder
Conditions
Keywords
depression, adolescents, aftercare, digital
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. . 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?
Interventions
OTHERMind-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
OTHERMind-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.
Sponsors
Minddistrict GmbH (E-Mental-Health platform)
Asklepios Fachklinikum Stadtroda GmbH
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| depressive symptoms (PHQ-A) at 12 weeks | 12 weeks after baseline | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anxiety symptoms (GAD-7) at 12 weeks | 12 weeks after baseline | GAD-7 total score: 0-4 (minimal anxiety) 5-9 (mild anxiety) 10-14 (moderate anxiety) 15-21 (severe anxiety) |
| mental health-related quality of life (KIDSCREEN-10) at 12 weeks | 12 weeks after baseline | global Health-Related Quality-of-Life (HRQoL) index (T-values) |
| psychosocial functioning (SDQ - self-completion) at 12 weeks | 12 weeks after baseline | total difficulties score (range 0 to 40, higher scores represent more difficulties) |
| Avoiding school/training at 12 weeks | 12 weeks after baseline | number of days absent since baseline |
| medication adherence at 12 weeks | 12 weeks after baseline | report if medication was taken as prescribed (yes or no response) |
| transfer knowledge from psychiatry treatment baseline at 12 weeks | 12 weeks after baseline | level of transfer knowledge from psychiatry since baseline (score between 0 and 4, higher score represents higher transfer) |
| inpatient treatment psychiatry at 12 weeks | 12 weeks after baseline | report of inpatient treatment in a psychiatric hospital since baseline (yes or no response) |
| ZUF-8 at 12 weeks (only Intervention groups) | 12 weeks after baseline | total score ZUF-8 (indicating patients satisfaction): high scale values indicate high satisfaction, low scale values indicate low satisfaction. |
| anxiety and depressive symptoms (RCADS-25) at 12 weeks | 12 weeks after baseline | Revised Children's Anxiety and Depression Scale (RCADS-25) total depression and anxiety score (range 0 to 75, higher scores represent more symptoms) |
| anxiety and depressive symptoms (RCADS-25) at 18 weeks | 18 weeks after baseline | RCADS-25 total depression and anxiety score (range 0 to 75, higher scores represent more symptoms) |
| anxiety symptoms (GAD-7) at 18 weeks | 18 weeks after baseline | GAD-7 total score: 0-4 (minimal anxiety) 5-9 (mild anxiety) 10-14 (moderate anxiety) 15-21 (severe anxiety) |
| mental health-related quality of life (KIDSCREEN-10) at 18 weeks | 18 weeks after baseline | global HRQoL index (T-values) |
| psychosocial functioning (SDQ - self-completion) at 18 weeks | 18 weeks after baseline | total difficulties score (range 0 to 40, higher scores represent more difficulties) |
| avoiding school/training at 18 weeks | 18 weeks after baseline | number of days absent since baseline |
| medication adherence at 18 weeks | 18 weeks after baseline | report if medication was taken as prescribed (yes or no response) |
| transfer knowledge frompsychiatry treatment baseline at 18 weeks | 18 weeks after baseline | level of transfer knowledge from psychaitry since baseline (score between 0 and 4, higher score represents higher transfer) |
| inpatient treatment psychiatry at 18 weeks | 18 weeks after baseline | report of inpatient treatment in a psychiatry hospital since baseline (yes or no response) |
| depressive symptoms (PHQ-A) at 18 weeks | 18 weeks after baseline | 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) |
Countries
Germany
Outcome results
None listed