Lonely in Depression

NCT07333027 | Recruiting

• 1 other identifier: 25-435-B
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this prospective study is to better understand the link between loneliness and depression in the inpatient psychiatric treatment of depression. It aims to answer: Do lonely and not lonely persons benefit the same way from inpatient depression treatment? Is loneliness a clinical relevant factor in inpatient treatment of depression? What are the underlying biopsychosocial mechanisms? Participants will be asked to do some

• self-report questionnaires
• clinical interview
• biosampling (blood, saliva, stool) at three main measurement timepoints (1. begin of inpatient treatment, 2. day of discharge, 3. three months after discharge).

Conditions

Depression Disorder; Loneliness

Keywords

loneliness; depression; prospective; biosampling; clinical

Outcome Measures

Primary Outcomes (4)

• Depression

  Montgomery-Åsberg Depression Rating Scale (MADRS) (10 Items, each item rated 0-6 points, minimum 0 points, maximum 60 points, higher scores indicate greater severity of depressive symptoms)

  Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2

• Loneliness

  3 Item UCLA Loneliness Scale (3-Item UCLA) (3 items, each item rated 1-3 points, minimum 3 points, maximum 9 points, higher scores indicate greater loneliness)

  Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2

• Depression

  Patient Health Questionnaire, 9-Item Depression Scale (PHQ-9) (9 Items, each item rated 0-4 points, minimum 0 points, maximum 27 points, higher scores indicate greater severity of depression)

  Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2

• Loneliness

  6-Item short scales for Loneliness, De Jong Gierveld Loneliness Scale (6-Item DJGLS) (6 Items, each item rated 1-3 points, before the total score is calculated, the items are dichotomized, thus resulting in a sum score ranging from 0 to 6, wherein scores of 0-1 indicate no loneliness, 2-4 indicate moderate loneliness, and 5-6 indicate severe loneliness)

  Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2

Secondary Outcomes (7)

• Social Support

  Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2

• Inpatient treatment duration

  Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4) to T1 (end of inpatient stay, normally 7 up to 50 weeks).

• Quality of life in self-report

  Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2

• Social Network measure (newly designed for this study)

  Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2

• General health status

  Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2

Other Outcomes (17)

• Blood markers (metabolic, LDL)

  Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2

• Blood markers (metabolic, HDL)

  Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2

• Blood markers (metabolic, HbA1c)

  Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 4), T1 (end of inpatient stay, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge); measured T0 to T1 and T0 to T2 and T1 to T2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who are admitted for inpatient treatment at one of the two psychiatric clinics in Erlangen (university hospital, community hospital), Germany, either electively or as an emergency case, due to depressive symptoms.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezirkskliniken Mittelfranken, Clinic for Psychiatry, Addiction, Psychotherapie and Psychosomatic Medicine, Am Europakanal, Germany: collaborator
• Friedrich-Alexander-Universität Erlangen-Nürnberg: lead

Study Sites (2)

Friedrich-Alexander-Universität Erlangen-Nürnberg

Erlangen, Bavaria, 91054, Germany

RECRUITING

Bezirkskliniken Mittelfranken, Clinic for Psychiatry, Addiction, Psychotherapie and Psychosomatic Medicine

Erlangen, Bavaria, 91056, Germany

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples: EDTA and Serum collection --\> blood, plasma, serum, cells (PBMCs, Leukocyten) Salvia samples: Salivette® Cortisol Stool samples: stool collection tubes with stabilizer --\> microbiome analysis

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Franziska Sonnauer, Dr. med., M.Sc.

  Department of Psychiatry and Psychotherapy, Friedrich-Alexander Universität Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franziska Sonnauer, Dr. med., M.Sc.

CONTACT

00499131-8534597; franziska.sonnauer@uk-erlangen.de

Franca Fries, Dr. med.

CONTACT

004991317530; Franca.Fries@bezirkskliniken-mfr.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Franziska Sonnauer, Principal Investigator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 12, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

DE (2)