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Investigating the effectiveness of an online-based program for the treatment of anxiety disorders (Novego) - A randomized controlled trial

Investigating the effectiveness of an online-based program for the treatment of anxiety disorders (Novego) - A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031668
Enrollment
310
Registered
2023-04-14
Start date
2023-04-24
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

F40.0 F40.01 F40.1 F40.2 F41.0

Interventions

Group 1: Intervention group = receives access to the internet-based support program after the baseline assessment Group 2: Waitlist control group = receives no additional treatment in the interventio
receives access to the intervention after 12 weeks (after follow-up-assessment)

Sponsors

IVPNetworks 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: F40.0x, F40.1, F40.2, F41.0 • Informed consent • Access to the Internet • Sufficient knowledge of the German language • Willingness to participate in three pseudonymized online surveys and willingness to independently use Novego - "Ängste überwinden"®. • 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: • 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 highly potent and/or atypical 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 anxiety symptomatology (sum score) at T1 compared to T0 as measured by the Beck Anxiety Inventory (BAI, Beck et al., 1988)

Secondary

MeasureTime frame
• Reduction in social anxiety symptomatology (sum score) at T1 compared to T0 as measured by the Liebowitz Social Anxiety Scale self-report (LSAS-SR; Baker et al., 2002) • Reduction in anxiety, depression, and stress symptomatology (sum score) at T1 compared to T0 as measured by the DASS-21 (Lovibond & Lovibond, 1995). • Increase in quality of life (mean score) at T1 compared to T0, as measured by the WHO-QOL-BREF (WHOQOL Group, 1998). • Increase in self-esteem (sum score) at T1 compared to T0, as measured by the RSES (Rosenberg, 1965) • Decrease in anxiety symptomatology (sum score) at T2 compared to T0, as measured by the Beck Anxiety Inventory (BAI, Beck et al., 1988) • Reduction in social anxiety symptomatology (sum score) at T2 compared to T0 as measured by the Liebowitz Social Anxiety Scale self-report (LSAS-SR; Baker et al., 2002) • Reduction in anxiety, depression, and stress symptomatology (sum score) at T2 compared to T0, as measured by the DASS-21 (Lovibond & Lovibond, 1995) • 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 to T0 as measured by the RSES (Rosenberg, 1965). • 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 T1, as measured by the PANEPS-I (Baumeister & Moritz, 2022) • Presence of other common mental disorders at T0, assessed by the WSQ (Donker et al., 2009) • Satisfaction of the participants with the program at T1, measured by the ZUF-8 (Schmidt et al., 1989). • Influence of attitude toward online interventions at time point T0, as measured by the Attitude toward Psychological Online Interventions (APOI; Schröder et al., 2015).

Countries

Germany

Contacts

Public ContactSteffen Moritz

Universitätsklinikum Hamburg-Eppendorf

moritz@uke.de+49 (40) 7410 56565

Outcome results

None listed

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