Unipolar depression and anxiety disorders Mental and Behavioural Disorders Depressive episode, Mild depressive episode, Moderate depressive episode, Severe depressive episode without psychotic symptoms, Other depressive episodes, Depressive episode, unspecified, Recurrent depressive disorder, Recurrent depressive disorder, current episode mild, Recurrent depressive disorder, current episode moderate, Recurrent depressive disorder, current episode severe without psychotic symptoms, Other recurr
Conditions
Interventions
Elona is a digital health application that supports patients in outpatient psychotherapy in the treatment of mental illnesses (depression, anxiety/panic disorders, hypochondriacal disorders) through a
Sponsors
Heinrich Heine University Düsseldorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All participants must have been diagnosed with one of the following ICD-10 diagnoses: F32: Depressive episode F32.0: Mild depressive episode F32.1: Moderate depressive episode F32.2: Severe depressive episode without psychotic symptoms F32.8: Other depressive episodes F32.9: Depressive episode, unspecified F33: Recurrent depressive disorder F33.0: Recurrent depressive disorder, current episode mild F33.1: Recurrent depressive disorder, current episode moderate F33.2: Recurrent depressive disorder, current episode severe without psychotic symptoms F33.8: Other recurrent depressive disorders F33.9: Recurrent depressive disorder, unspecified F34: Persistent mood [affective] disorders F34.0: Cyclothymia F34.1: Dysthymia F34.8: Other persistent mood [affective] disorders F34.9: Persistent mood [affective] disorder, unspecified F40.0 Agoraphobia F40.00 Agoraphobia without panic disorder F40.01 Agoraphobia with panic disorder F40.1 Social phobias F40.2 Specific (isolated) phobias F40.8 Other phobic anxiety disorders F40.9 Phobic anxiety disorder, unspecified F41.0 Panic disorder [episodic paroxysmal anxiety] F41.1 Generalized anxiety disorder F41.2 Mixed anxiety and depressive disorder F41.3 Other mixed anxiety disorders F41.8 Other specified anxiety disorders F41.9 Anxiety disorder, unspecified F45.2 Hypochondriacal disorder 2. Participants need to be between the age of 18 and 65 years 3. Participants need to possess sufficient German language skills (in writing and reading) 4. Participants need to possess a smartphone (iOS or Android operating system) with internet access 5. Participants need to provide signed and dated informed consent and are willing to comply with the protocol
Exclusion criteria
Exclusion criteria: 1. All participants without the inclusion ICD-10 diagnosis criteria as well as participants with the following ICD-10 diagnoses are excluded: 1.1. F0x.x: Organic, including symptomatic, mental disorders 1.2. F1x.x Mental and behavioural disorders due to psychoactive substance use (except F17.x) 1.3. F2x.x: Schizophrenia, schizotypal and delusional disorders 1.4. F31: Bipolar affective disorder 1.5. F32.3: Severe depressive episode with psychotic symptoms 1.6. F33.3: Recurrent depressive disorder, current episode severe with psychotic symptoms 2. Individuals with acute suicidality (operationalized via BDI-II screening question greater than 1 or first checkup) are excluded from this study first checkup) 3. Participants under the age of 18 years 4. Participants without any access to a smartphone (iOS or Android operating system) with internet access 5. Participants without German language proficiency If a participant is currently enrolled or is planning to participate in a potentially confounding drug or device trial during the study, enrollment into this study needs to be pre-approved
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group 1 (patients with depression): Depression symptoms measured using the 5-point (Likert Scale) BDI-II online questionnaire at the beginning of the treatment and after 6 and 12 weeks Group 2 (patients with anxiety): Anxiety symptoms measured using the 5-point (Likert Scale) BAI online questionnaire at the beginning of the treatment and after 6 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Groups 1 and 2: 1. Quality of life measured using the 5-point (Likert Scale) WHOQOL- BREF online questionnaire at the beginning of the treatment and after 6 and 12 weeks 2. Work and social adjustment measured using the 9-point (Likert scale) WSAS (ger.: ASAS) online questionnaire at the beginning of the treatment and after 6 and 12 weeks 3. Self-efficacy measured using the 4-point (Likert scale) SWE online questionnaire at the beginning of the treatment and after 6 and 12 weeks 4. Negative effects measured using the 5-point (Likert scale) NEQ online questionnaire at the beginning of the treatment and after 6 and 12 weeks 5. Working alliance measured using the 5-point (Likert scale) WAI-SR online questionnaire at the beginning of the treatment and after 6 and 12 weeks 6. Mental health literacy measured using the 5-point (Likert scale) MHLS online questionnaire at the beginning of the treatment and after 6 and 12 weeks 7. Willingness to comply with homework or interventions, measured using non-standardized items 5-point (Likert Scale) online questionnaire at the beginning of the treatment and after 6 and 12 weeks | — |
Countries
Germany
Outcome results
None listed