NCT Number: NCT07007247
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?
Interested in participating?
Request Info12 year–17 year
All sexes
Interventional
Not applicable
Asklepios Klinikum Harburg, Hamburg, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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
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.
Other names: MindWin blended care
Time frame: 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)
Time frame: 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)
Time frame: 12 weeks after baseline
GAD-7 total score:
0-4 (minimal anxiety) 5-9 (mild anxiety) 10-14 (moderate anxiety) 15-21 (severe anxiety)
Time frame: 12 weeks after baseline
global Health-Related Quality-of-Life (HRQoL) index (T-values)
Time frame: 12 weeks after baseline
total difficulties score (range 0 to 40, higher scores represent more difficulties)
Time frame: 12 weeks after baseline
number of days absent since baseline
Time frame: 12 weeks after baseline
report if medication was taken as prescribed (yes or no response)
Time frame: 12 weeks after baseline
level of transfer knowledge from psychiatry since baseline (score between 0 and 4, higher score represents higher transfer)
Time frame: 12 weeks after baseline
report of inpatient treatment in a psychiatric hospital since baseline (yes or no response)
Time frame: 12 weeks after baseline
total score ZUF-8 (indicating patients satisfaction): high scale values indicate high "satisfaction", low scale values indicate low "satisfaction".
Time frame: 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)
Time frame: 18 weeks after baseline
RCADS-25 total depression and anxiety score (range 0 to 75, higher scores represent more symptoms)
Time frame: 18 weeks after baseline
GAD-7 total score:
0-4 (minimal anxiety) 5-9 (mild anxiety) 10-14 (moderate anxiety) 15-21 (severe anxiety)
Time frame: 18 weeks after baseline
global HRQoL index (T-values)
Time frame: 18 weeks after baseline
total difficulties score (range 0 to 40, higher scores represent more difficulties)
Time frame: 18 weeks after baseline
number of days absent since baseline
Time frame: 18 weeks after baseline
report if medication was taken as prescribed (yes or no response)
Time frame: 18 weeks after baseline
level of transfer knowledge from psychaitry since baseline (score between 0 and 4, higher score represents higher transfer)
Time frame: 18 weeks after baseline
report of inpatient treatment in a psychiatry hospital since baseline (yes or no response)
Universitätsklinikum Hamburg-Eppendorf
Other
Development and Evaluation of a Digital Aftercare Program for Adolescents (12-17 Years) With Depressive Symptoms After Hospital Discharge (Mind-WIN Pilot Study)
Acronym: MindWinPilot
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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