TraumaSleep Study

Not Applicable

Recruiting

• Conditions: F43.1; F43.2; Post-traumatic stress disorder; Adjustment disorders

• Registration Number: DRKS00025713
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein Campus Lübeck

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Traumatic event within the last three months AND traumarelated symptoms

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Additionally, anxiety (BAI, Steer & Beck, 1997), depression (BDI-II, Beck et al., 1996) and life quality (WHODAS 2.0) are measured at all three assessment points.