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Investigating the effects of digital cognitive behavioral psychotherapy of insomnia (dCBT-I) on sleep in insomnia

Investigating the effects of digital cognitive behavioral psychotherapy of insomnia (dCBT-I) on sleep in insomnia - WITHIN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00030897
Enrollment
60
Registered
2023-01-09
Start date
2023-01-10
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

F51.0 G47.0

Interventions

Group 1: Group 1 receives access to somnio (mementor DE GmbH), a digital health application which delivers cognitive-behavioral therapy for insomnia (8 weeks). Group 2: Group 2 receives access to mali

Sponsors

Heinrich-Heine-Universität Düsseldorf
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Confident use of the smartphone/tablet/computer - Stable Internet access

Exclusion criteria

Exclusion criteria: - Bipolar disorder - Epilepsy - Pregnancy - Shift work - Presence of another sleep disorder (diagnostic interview) - Parallel psychotherapy for the treatment of sleep disorders - Regular drug and alcohol use (> 3 glasses of alcohol per day, more than 21 days), marijuana use (> 1x per week; self-report) - Acute suicidality (suicide item > 1 in the Beck Depression Inventory BDI & suicidality according to questioning in a telephone interview) - Psychosis

Design outcomes

Primary

MeasureTime frame
Insomnia severity, post-treatment (8 & 16 weeks post-randomization) as measured with the Insomnia Severity Index (ISI)

Secondary

MeasureTime frame
- Sleep continuity (as measured with a sleep diary and actigraphy; continuously for 8 weeks during the intervention) - Dysfunctional beliefs about sleep (DBAS; 8 & 16 weeks post-randomization) - Pre-Sleep Arousal (PSAS; 8 & 16 weeks post-randomization) - Daytime well-being (WHO-5; 8 & 16 weeks post-randomization) - Quality of life (WHQOL_BREF; 8 & 16 weeks post-randomization) - Symptoms of anxiety and depression (HADS; 8 & 16 weeks post-randomization)

Countries

Germany

Contacts

Public ContactAnnika Gieselmann

Heinrich-Heine-Universität Düsseldorf

Annika.Gieselmann@hhu.de+49 211 18-10584

Outcome results

None listed

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