Investigation of the effectiveness of the internet-based intervention ‘Novego... sleep better’ - a randomised controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034932

Enrollment

126

Registered

2024-10-07

Start date

2025-02-12

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

F51.0 G47.0

Interventions

Group 1: Intervention group = access to the internet-based support program ‘Novego... sleep better’ Group 2: Waitlist Control Group = receives no additional treatment during the intervention period (o

receives access to the intervention after 12 weeks (after the follow-up)

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 a specialist or psychotherapist: F51.0, G47.0 · informed consent · internet access · sufficient knowledge of the German language · ISI sum value = 8 points to baseline · Consent and willingness to participate in the study including three anonymous online surveys via the online survey tool Qualtrics and independent use of the intervention ‘Novego... sleep better’ · Patients must have a stable treatment situation (pharmacotherapy and/or psychotherapy or waiting situation) at least 4 weeks prior to randomisation and should maintain this over the study period if possible

Exclusion criteria

Exclusion criteria: · PHQ-9 total value = 20 points · Presence of a psychotic or bipolar disorder (lifetime) · Acute suicidal behaviour within the last 4 weeks · Dementia · Current use of highly potent and/or atypical antipsychotics · Presence of a severe disease which, in the opinion of the investigator, precludes the patient's participation in the study until the end of the study

Design outcomes

Primary

Measure	Time frame
Change in insomnia severity (total value) at time T1 (6 weeks after baseline) compared to T0 (baseline), measured using the ISI (Bastien et al., 2001)	—

Secondary

Measure	Time frame
· Change in depressive symptoms (total score) at T1 compared to T0, measured using the PHQ-9 (Gräfe et al., 2004; Kroenke et al., 2001) · Change in health literacy (total score) at T1 compared to T0, measured using the PHCS (Smith et al., 1995) · Change in insomnia severity (total value) at time T2 (12 weeks after Baseline) compared to T0, measured using the ISI (Bastien et al., 2001) · Change in depressive symptoms (total score) at T2 compared to T0, measured using the PHQ-9 (Gräfe et al., 2004; Kroenke et al., 2001) · Change in health literacy (total score) at T2 compared to T0, measured using the PHCS (Smith et al., 1995)	—

Measure

Time frame

· Change in depressive symptoms (total score) at T1 compared to T0, measured using the PHQ-9 (Gräfe et al., 2004; Kroenke et al., 2001) · Change in health literacy (total score) at T1 compared to T0, measured using the PHCS (Smith et al., 1995) · Change in insomnia severity (total value) at time T2 (12 weeks after Baseline) compared to T0, measured using the ISI (Bastien et al., 2001) · Change in depressive symptoms (total score) at T2 compared to T0, measured using the PHQ-9 (Gräfe et al., 2004; Kroenke et al., 2001) · Change in health literacy (total score) at T2 compared to T0, measured using the PHCS (Smith et al., 1995)

—

Countries

Germany

Contacts

Public ContactSteffen Moritz

Universitätsklinikum Hamburg-Eppendorf - Klinik und Poliklinik für Psychiatrie und Psychotherapie

moritz@uke.de+49 40 7410 56565

Outcome results

None listed

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