Feasibility Study of EmoDtx, a Digital Health Application for Depression: Preliminary Effectiveness and Usability Evaluation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036362

Enrollment

Registered

2025-04-22

Start date

2025-04-30

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32

Interventions

Group 1: Adult participants self-reporting depressive symptoms, assessed with a PHQ-9 Score >=5 . Participants will be recruited through online advertisements on social media (relevant groups), the co

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Participants self-reporting with depressive symptoms, as assessed with a PHQ-9 score >=5 -Participants willing and able to participate (i.e willing to use the EmoDTx App and having the necessary technical equipment to use it) -Participants who read, write and understand German -Participants giving Informed Consent

Exclusion criteria

Exclusion criteria: -Participants presenting lifetime diagnosis of psychotic or bipolar disorder -Participants presenting with acute suicidal ideations as assessed with a PHQ-9 item 9 >2 -Participants deprived of liberty by administrative or judicial decision or placed under guardianship. -Participants with no access to an Android smartphone with an internet connection

Design outcomes

Primary

Measure	Time frame
Reduction in depressive symptoms (sum score) at T1 compared to T0 as measured by the PHQ-9.	—

Secondary

Measure	Time frame
Reduction in depressive symptoms (sum score) at T1 compared to T0 as measured by the BDI-II. Reduction in anxiety severity (sum score) at T1 compared to T0 as measured by the GAD-7. Increase in quality of life (mean score) at T1 compared with T0, as measured by the WHO-QOL-BREF and the EQ-5D-5L. Increase in self-esteem (sum score) at T1 compared to T0 as measured by the RSES. Decrease in alexithymia levels (sum score) at T1 compared to T0 as measured by the TAS-20 Sum of the participants' satisfaction with the program at time T1, assessed via the CSQ-8. Sum of the participant’s treatment adherence at T1 via the TAPQ along with objective usage data, including the number of sessions completed, total usage duration, and frequency of use. Proportion of participants reporting adverse effects at T1, categorized by PANEPS subscales evaluating the balance of positive and negative effects of psychotherapy.	—

Measure

Time frame

Reduction in depressive symptoms (sum score) at T1 compared to T0 as measured by the BDI-II. Reduction in anxiety severity (sum score) at T1 compared to T0 as measured by the GAD-7. Increase in quality of life (mean score) at T1 compared with T0, as measured by the WHO-QOL-BREF and the EQ-5D-5L. Increase in self-esteem (sum score) at T1 compared to T0 as measured by the RSES. Decrease in alexithymia levels (sum score) at T1 compared to T0 as measured by the TAS-20 Sum of the participants' satisfaction with the program at time T1, assessed via the CSQ-8. Sum of the participant’s treatment adherence at T1 via the TAPQ along with objective usage data, including the number of sessions completed, total usage duration, and frequency of use. Proportion of participants reporting adverse effects at T1, categorized by PANEPS subscales evaluating the balance of positive and negative effects of psychotherapy.

—

Countries

Germany

Contacts

Public ContactJan Philipp Klein

Zentrum für Integrative Psychiatrie ZiP gGmbH, University of Lübeck

philipp.klein@uksh.de+49 451 500 98871

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026