Evaluation of the effectiveness of a digital aftercare intervention for depression. A prospective randomized controlled trial

Phase 3

• Conditions: F32.1; F32.2; F33.1; F33.2; F32.0; F33.0; Severe depressive episode without psychotic symptoms; Moderate depressive episode; Recurrent depressive disorder, current episode moderate; Recurrent depressive disorder, current episode severe without psychotic symptoms

• Registration Number: DRKS00016663
• Lead Sponsor: Friedrich-Alexander-University Erlangen-Nuremberg Department of Clinical Psychology and Psychotherapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Access to a smartphone using Android (version 5 or above) or iOS (version 12 or above); moderate or severe depressive episode - including recurrent episodes - (F32.1, F32.2, F.33.1, F33.2); release from inpatient treatment without further treatment within the next four weeks (exluding medical attention and contact to social workers)

Exclusion Criteria

Acute suicidality, acute psychotic symptoms, language or neurocognitive barriers, if treatment of following disorders is the priority: addictive disorders, eating disorders, personality disorder

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depressive symptoms severity (HAM-D) after 4 and 16 weeks

Secondary Outcome Measures

Name	Time	Method
Baseline, Postassessment, Follow-Up: Depressive symptoms severity (PHQ-9), dysfunctional attitudes (DAS), sleep quality (ISI), affective disorders section of the SCID, quality of life (SF-12)<br><br>intermediate survey: Credibility and Expectancy Questionnaire (CEQ)<br><br>Baseline: medication<br><br>Baseline, Follow-up: claiming and costs of medical care, days absent and present at work (TiC-P)