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TraumaSleep Study

TraumaSleep Study - TSS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025713
Enrollment
104
Registered
2021-06-29
Start date
2022-02-02
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

F43.1 F43.2

Interventions

Group 1: Cognitive-behavioral therapy for insomnia delivered via the "Somnio" app in addition to treatment-as-usual in trauma clinic Group 2: Filling in of sleep-diary in addition to treatment-as-usua

Sponsors

Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Traumatic event within the last three months AND traumarelated symptoms

Exclusion criteria

Exclusion criteria: Intake of benzodiazepines, steroids, opiates, neuroleptics, melatonine, beta-blockers, anti depressants, anti histamines, stimulants or over-the-counter sleep medication. Lifetime diagnosis of schizophrenia, bipolar disorder or more than 2 depressive episodes Alcohol or substance abuse in the last year IQ < 80 systemic, neurological illness acute suicidal tendencies non-fluency in german shift work or intercontonental flights in the last 30 days sleep apnea

Design outcomes

Primary

MeasureTime frame
Posttraumatic symptoms are assessed with questionnaires (PCL-5, Weathers et al., 2013; PTCI, Foa et al., 1999). Sleep quality is measured subjectively with sleep diaries and the PSQI (Buysse et al., 1989). Symptoms are measured prior to the intervention as well as 10 weeks and six months after inclusion in the study.

Secondary

MeasureTime frame
Additionally, anxiety (GAD-7, Spitzer et al., 2006), depression (QIDS-SR16, Rush et al., 2003) and life quality (WHODAS 2.0) are measured at all three assessment points.

Countries

Germany

Contacts

Public ContactJovana;Jovana Lehmann-Grube;Lehmann-Grube

Zentrum für Integrative PsychiatrieKlinik für Psychiatrie und PsychotherapieTranslational Psychiatry Unit, Research Group Sleep and Mental Health;Zentrum für Integrative PsychiatrieKlinik für Psychiatrie und PsychotherapieTranslational Psychiatry Unit, Research Group Sleep and Mental Health

j.lehmanngrube@uni-luebeck.de;j.lehmanngrube@uni-luebeck.de0451 3101 7513;+49451 3101 7513

Outcome results

None listed

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