Loneliness and depression in hospital care
Effects of Loneliness in the Treatment of Depression
This project will see if loneliness changes how adults with depression improve during and after inpatient psychiatric treatment by using questionnaires, interviews, and blood, saliva, and stool samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Friedrich-Alexander-Universität Erlangen-Nürnberg Academic / other |
| Locations | 2 sites (Erlangen, Bavaria and 1 other locations) |
| Trial ID | NCT07333027 on ClinicalTrials.gov |
What this trial studies
This prospective, noninterventional longitudinal study follows adults admitted for depression at two Erlangen psychiatric clinics with measurements at admission, discharge, and three months after discharge, plus brief interim checks every two weeks during hospitalization. Participants complete self-report questionnaires and clinical interviews and provide biosamples (blood, saliva, stool) at three main timepoints. Every patient admitted with depressive symptoms who meets inclusion criteria will be screened and invited to participate, and individual inpatient stays determine the timing of the second measurement. The study was powered acknowledging that effect sizes for loneliness-depression interactions in clinical populations are currently uncertain.
Who should consider this trial
Good fit: Adults (18+) admitted as inpatients to the participating Erlangen psychiatric clinics with a primary ICD-10 diagnosis of depressive episode or recurrent depression (F32 or F33), who speak German, can give informed consent, and have an expected inpatient stay of at least seven days.
Not a fit: People who cannot give informed consent because of acute psychosis or stuporous depression, those with inpatient stays under seven days, non-German speakers, pregnant or breastfeeding people, and those who previously participated are unlikely to take part or benefit.
Why it matters
Potential benefit: If successful, the results could help clinicians identify patients whose loneliness affects treatment response and guide targeted social, psychological, or biological support during and after hospitalization.
How similar studies have performed: Previous research links loneliness to worse depression outcomes in outpatient and community samples, but longitudinal inpatient designs with repeated biosampling like this are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * primary diagnosis of depression according to ICD-10 (F32 or F33), as diagnosed by a physician or clinical psychologist in conjunction with the M.I.N.I. Mini-International Neuropsychiatric Interview diagnostic tools * inpatient elective or emergency admission to one of the two psychiatric clinics; - age over 18 years * sufficient understanding of spoken and written German * informed voluntary consent Exclusion Criteria: * a current lack of capacity to provide consent (e.g., pronounced psychotic symptoms, stuporous depressive syndrome, and thought constriction to suicidality) * previous participation in the study * pregnancy or breastfeeding * inpatient stay of less than 7 days, even if the patients initially met the inclusion criteria.
Where this trial is running
Erlangen, Bavaria and 1 other locations
- Friedrich-Alexander-Universität Erlangen-Nürnberg — Erlangen, Bavaria, Germany (Recruiting)
- Bezirkskliniken Mittelfranken, Clinic for Psychiatry, Addiction, Psychotherapie and Psychosomatic Medicine — Erlangen, Bavaria, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Franziska Sonnauer, Dr. med., M.Sc. — Department of Psychiatry and Psychotherapy, Friedrich-Alexander Universität Erlangen-Nürnberg
- Study coordinator: Franziska Sonnauer, Dr. med., M.Sc.
- Email: franziska.sonnauer@uk-erlangen.de
- Phone: 00499131-8534597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.