About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial 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.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Depression (symptom severity)
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)
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)
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)
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)
Secondary outcomes
Social Support
Fragebogen zur Sozialen Unterstützung (F-SoZ-U 14) (14 Item shortend form, each item rated 0-4 points, minimum 0 points, maximum 56 points, higher total scores indicating higher levels of perceived social support)
Inpatient treatment duration
in days
Quality of life in self-report
World Health Organization-Five Well-Being Index (WHO-5) (5 Items, each item rated 0-5 points, minimum 0 points, maximum 25 points, the total score (0-25) is transformed to a scale ranging from 0 to 100, with scores ≤50 indicating diminished well-being and higher scores representing higher well-beeing)
Social Network measure (newly designed for this study)
As there is no culture and language adapted version of a social network indice available an adapted and German-translated version is used to capture participants' social interaction partners during the prior two weeks. The questionnaire was newly developed, with item content informed by existing validated scales (Cohen Social Network Index (SNI), Lubben Social Network Scale (LSNS), Berkman - Social Network/Integration). Via the use of a yes/no response format, participants indicated whether they had personal or telephone contact with each of the following: (1) spouse or partner, (2) own children, (3) parents or parent-like figures, (4) other relatives (e.g., siblings, uncles, or aunts), (5) friends, (6) neighbors, (7) colleagues, (8) people known through voluntary activities, (9) in-laws (parents, sons, or daughters-in-law), and (10) members of their social group (e.g., community, congregation, sports, or music clubs). Higher total scores indicate greater social connectedness.
Other outcomes
Blood markers (metabolic, LDL)
LDL cholesterin \[mg/dl or mmol/l\], higher values (\> 100 mg/dl or \> 2.6 mmol/l) represent unfavorable metabolic risk
Blood markers (metabolic, HDL)
HDL cholesterin \[mg/dl or mmol/l), \< 40 mg/dl men and \< 50 mg/dl women represents unfavorable metabolic risk, ≥ 40 mg/dl men ≥ 50 mg/dl women acceptable, ≥ 60 mg/dl protective
Blood markers (metabolic, HbA1c)
HbA1c \[%\], higher values (\> 5.7%) represent unfavorable metabolic risk
Blood markers (Sphingolipid metabolism)
Sphingolipid metabolism enzyme activity of secretory acid sphingomyelinase (S-ASM) \[nmol/mL/h/µL\], higher leveles represent more inflammation/apoptosis enzyme activity of neutral acid sphingomyelinase (N-ASM) \[nmol/mL/h/µL\], higher levels represent cellular stress/apotosis Ceramide \[nmol/L\], higher levels represent more inflammation/apoptosis
Sponsors and contacts
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Friedrich-Alexander-Universität Erlangen-Nürnberg
Lead sponsor
Bezirkskliniken Mittelfranken, Clinic for Psychiatry, Addiction, Psychotherapie and Psychosomatic Medicine, Am Europakanal, Germany
Collaborator