A randomized controlled study to evaluate a digital intervention for treating unipolar depression in adults

Not Applicable

• Conditions: Treatment of unipolar depression in patients on the waiting list for the outpatient psychotherapeutic treatment; Mental and Behavioural Disorders

• Registration Number: ISRCTN54139009
• Lead Sponsor: Elona Health GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-06
• Last Update Posted: 18 July 2023
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

All subjects must have been diagnosed with one of the following ICD-10 diagnoses:
F32.0: Mild depressive episode
F32.1: Moderate depressive episode
F32.2: Severe depressive episode
F33.0: Recurrent depressive disorder, current episode mild
F33.1: Recurrent depressive disorder, current episode moderate
F33.2: Recurrent depressive disorder, current episode severe

Subjects further need to:
1. Be at least 18 years old
2. Possess sufficient German language skills (in writing and reading)
3. Possess a smartphone (iOS or Android operating system) with internet access
4. Provide signed and dated informed consent and be willing to comply with the protocol

Exclusion Criteria

All subjects without the inclusion ICD-10 diagnosis criteria, as well as subjects with the following ICD-10 diagnoses, are excluded:
F00-F09: Organic, including symptomatic, mental disorders
F10-F19 Mental and behavioural disorders due to psychoactive substance use (except F17.1, F17.2, F17.3)
F20-F29: Schizophrenia, schizotypal and delusional disorders
F30: Manic episode
F31.0, F31.1, F31.2, F31.5, F31.6, F31.8, F31.9: Bipolar disorder current hypomanic or manic episode
F32.3: Severe depressive episode with psychotic symptoms
F33.3: Recurrent depressive disorder, current episode severe with psychotic symptoms

1. Subjects with acute suicidality (assessed via suicidality screening of the mini-DIPS at the initial screening)
2. Subjects under the age of 18 years
3. Subjects without any access to a smartphone (iOS or Android operating system) with internet access
4. Subjects without German language proficiency

If a subject 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 by the principal investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Assessments will take place at baseline (T0), 5 weeks after treatment start (T1), and 10 weeks after treatment start (T2):<br><br> Primary effectiveness objective:<br> Symptoms of depression measured using PHQ-9<br><br> Primary safety objective:<br> Number or seriousness of adverse events measured using patient records<br>

Secondary Outcome Measures

Name	Time	Method
<br> Assessments will take place at baseline (T0), 5 weeks after treatment start (T1), and 10 weeks after treatment start (T2):<br> 1. Symptoms of generalized anxiety measured with the GAD-7<br> 2. Psychological health measured with the psychological health subscale of the WHOQOL-BREF<br> 3. Work and social maladjustment measured with the WSAS<br> 4. Self-efficacy measured with the GSE<br> 5. Depression literacy measured with the D-Lit<br>