Evaluation of the effectiveness of an online-based support program for the treatment of depression (Novego®) - A randomized controlled trial

Not Applicable

• Conditions: F32.0; F32.1; F32.2; F32.8; F32.9; F33.0; F33.1; F33.2; F33.8; F33.9

• Registration Number: DRKS00027459
• Lead Sponsor: IVP Networks GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-23
• Study Completion: 2023-06-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 311

Inclusion Criteria

• one of the following diagnoses according to ICD-10 made by specialists or psychotherapists: F32.0, F32.1, F32.2, F32.8, F32.9, F33.0, F33.1, F33.2, F33.8, F33.9, F34.1
• A sum score on the PHQ-9 at the time of the baseline interview of at least 5 (at least mild expression of depression)
• informed consent
• access to the Internet
• sufficient knowledge of the German language
• willingness to participate in three anonymous online surveys and willingness to independently use Novego - Depressionen bewältigen®.
• Patients must be in a stable therapy situation (pharmacotherapy and/or psychotherapy or waiting situation) at least 4 weeks before randomization and should maintain this situation as far as possible during the study period.

Exclusion Criteria

• the presence of a psychotic or bipolar disorder (lifetime)
• acute suicidal behavior within the last 4 weeks
• dementia
• alcohol or substance dependence within the last 6 months
• current use of antipsychotics
• Presence of a serious illness which, in the opinion of the investigator, precludes the patient's participation in the study until the end of the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in depressive symptomatology (sum score) at T2 compared to T0, as measured by the Beck Depression Inventory-II (BDI-II; Beck, Steer, & Brown, 1996)

Secondary Outcome Measures

Name	Time	Method
• Reduction in depressive symptomatology (sum score) at T2 compared to T0, as measured by the PHQ-9 (Gräfe et al., 2004; Kroenke et al., 2001)<br>• Increase in quality of life (mean score) at T2 compared to T0, as measured by the WHO-QOL-BREF (WHOQOL Group, 1998).<br>• Increase in self-esteem (sum score) at T2 compared with T0, as measured by the RSES (Rosenberg, 1965)<br>• Decrease in depressive symptomatology (sum score BDI-II and PHQ-9) at T1 compared to T0.<br>• Mean score of positive treatment expectancy at T0, as measured by the TEX-Q (Alberts et al., 2020)<br>• Frequency of other positive and negative effects (including side effects) of the intervention at time T2, as measured by the PANEPS-I (Baumeister & Moritz, in press)<br>• Presence of other common mental disorders at time T0, assessed by the WSQ (Donker et al., 2009)<br>• Satisfaction of the participants with the program at T2, measured by the ZUF-8 (Schmidt et al., 1989)