F30-F69 F51 F30-F39 F40-F48 F50-F59 F60-F69
Conditions
Interventions
Group 1: All patients receive regular inpatient complex psychosomatic-psychotherapeutic treatment (tertiary care). As part of the study, the following diagnostic and somnological assessments are condu
Sponsors
Universitätsklinikum Köln, Klinik und Poliklinik für Psychosomatik und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inpatient admission for complex psychosomatic-psychotherapeutic treatment at the Department of Psychosomatics and Psychotherapy, University Hospital Cologne. Sufficient knowledge of the German language to independently complete the study questionnaires. Willingness to participate in the study and provision of written informed consent.
Exclusion criteria
Exclusion criteria: Acute somatic diseases that require transfer to another medical department or hospital. Presence of severe psychiatric disorders (e.g., acute psychosis, acute suicidality) that make participation in the study impossible. Cognitive impairments that prevent comprehension of the study contents and completion of the questionnaires. Insufficient reading skills or inadequate knowledge of the German language.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Point prevalence, type, and extent of sleep disorders in tertiary psychosomatic-psychotherapeutic care. Measurement methods / Instruments: The assessment is conducted using a combination of objective and subjective measurement methods: Objective: Nocturnal somnographic measurement ("Scala" device, Löwenstein Medical) with recording of EEG, EOG, flow sensor, respiratory excursions (or respiratory effort), and pulse oximetry to assess sleep architecture. Subjective: Validated self-report questionnaires, in particular the Pittsburgh Sleep Quality Index (PSQI) to assess general sleep quality and the Insomnia Severity Index (ISI) to determine the severity of insomnia. Time of measurement: At two measurement time points: During the week of inpatient admission (T0) and in treatment week 8 (T1). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Course and Treatment Effects Secondary Endpoint 1: Objective sleep architecture Description: Change in sleep architecture (e.g., proportion of REM sleep, deep sleep/slow-wave sleep, sleep efficiency) over the course of treatment. Measurement method: Difference in parameters from nocturnal somnography. Time point: Week of admission (T0) vs. treatment week 8 (T1). Secondary Endpoint 2: Subjective sleep quality Description: Change in perceived sleep quality, insomnia severity, and daytime sleepiness. Measurement method: Difference in scores of PSQI, ISI, and ESS. Time point: Week of admission (T0) vs. treatment week 8 (T1). 2. Correlations and Comorbidities Secondary Endpoint 3: Mental health diagnoses Description: Correlation of sleep parameters with specific primary and secondary diagnoses and their severity. Measurement method: Comparison of somnography, PSQI, and ISI with the results from Mini-DIPS, SCID-II, PHQ-D, and OPD-SFK. Time point: Week of admission (T0) and treatment week 8 (T1). Secondary Endpoint 4: Quality of life Description: Association between the severity of sleep disorders and health-related quality of life. Measurement method: Correlation of sleep parameters with the WHODAS 2.0 score. Time point: Week of admission (T0) and treatment week 8 (T1). Secondary Endpoint 5: Somatoform symptom burden Description: Correlation between the severity of somatoform symptom burden and sleep quality. Measurement method: Correlation of the PHQ-15 with somnography data and PSQI. Time point: Week of admission (T0) and treatment week 8 (T1). Secondary Endpoint 6: Impact of traumatization Description: Association between traumatic life events and sleep-specific parameters (e.g., sleep fragmentation, nightmares). Measurement method: Correlation of the LEC-5 score with the MADRE and arousals in somnography. Time point: Week of admission (T0) and treatment week 8 (T1). 3. Specific Sleep and Behavioral Parameters Secondary Endpoint 7: D | — |
Countries
Germany
Contacts
Public ContactMichaela Henning
Universitätsklinikum Köln, Klinik und Poliklinik für Psychosomatik und Psychotherapie
Outcome results
None listed