Clinical trial Recruiting at 1 site Observational Ages 18 and up

Loneliness and depression in hospital care

Official title: Effects of Loneliness in the Treatment of Depression

Run by Friedrich-Alexander-Universität Erlangen-Nürnberg · NCT07333027 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorFriedrich-Alexander-Universität Erlangen-Nürnberg
Academic / other
Locations2 sites (Erlangen, Bavaria and 1 other locations)
StatusRecruiting
StartedFebruary 5, 2026
Main results expectedSeptember 2027
Study endsSeptember 2027
Registry record updatedJune 15, 2026
Trial IDNCT07333027 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.