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) (MindWinPilot)

Universitätsklinikum Hamburg-Eppendorf

Status: Not yet enrolling

Conditions: Depression, Unipolar; Depressive Disorder

Treatments: Other: Mind-WIN blended care; Other: Mind-WIN self-help only

Study type: Interventional

Funder types: Other

Identifiers

NCT07007247

Mind-Win pilot study

03DPS1033B (Other Grant/Funding Number)

Details and patient eligibility

About

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.

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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?

Enrollment: 120 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Mind-Win self-help only

Experimental group

Description:

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.

Treatment:

Other: Mind-WIN self-help only

Mind-Win blended care

Experimental group

Description:

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.

Treatment:

Other: Mind-WIN blended care

Care-As-Usual

No Intervention group

Description:

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).