Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00027459
Enrollment
310
Registered
2021-12-23
Start date
2022-01-06
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

F32.0 F32.1 F32.2 F32.8 F32.9 F33.0 F33.1 F33.2 F33.8 F33.9 F34.1

Interventions

Group 1: Intervention group = receives access to the internet-based support program Novego - "Depressionen bewältigen"® Group 2: Waiting control group = receives no additional treatment during the int
receives access to the intervention after 12 weeks (after post-survey)

Sponsors

IVP Networks GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
• 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) • Increase in quality of life (mean score) at T2 compared to T0, as measured by the WHO-QOL-BREF (WHOQOL Group, 1998). • Increase in self-esteem (sum score) at T2 compared with T0, as measured by the RSES (Rosenberg, 1965) • Decrease in depressive symptomatology (sum score BDI-II and PHQ-9) at T1 compared to T0. • Mean score of positive treatment expectancy at T0, as measured by the TEX-Q (Alberts et al., 2020) • 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) • Presence of other common mental disorders at time T0, assessed by the WSQ (Donker et al., 2009) • Satisfaction of the participants with the program at T2, measured by the ZUF-8 (Schmidt et al., 1989)

Countries

Germany

Contacts

Public ContactSteffen Moritz

Universitätsklinikum Hamburg-Eppendorf, Zentrum für Psychosoziale Medizin, Arbeitsgruppe Klinische Neuropsychologie

moritz@uke.de+49 04 7410 56565

Outcome results

None listed

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