Lonely in Depression

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFriedrich-Alexander-Universität Erlangen-Nürnberg

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 7), T1 (end of inpatient stay ± 7 d, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge ± 7 d); measured T0 to T1 and T0 to T2 and T1 to T2
2

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)

Time frame
Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 7), T1 (end of inpatient stay ± 7 d, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge ± 7 d); measured T0 to T1 and T0 to T2 and T1 to T2
3

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)

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

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)

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

Secondary outcomes

1

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)

Time frame
Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 7), T1 (end of inpatient stay ± 7 d, normally 7 up to 50 weeks), Follow-Up/T2 (three months after clinical discharge ± 7 d); measured T0 to T1 and T0 to T2 and T1 to T2
2

Inpatient treatment duration

in days

Time frame
Baseline/T0 (day 1 of inpatient stay) to T1 (end of inpatient stay, normally 7 up to 50 weeks).
3

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)

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

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.

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

Other outcomes

1

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

Time frame
Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 7), T1 (end of inpatient stay ± 7 d, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge ± 7 d); measured T0 to T1 and T0 to T2 and T1 to T2
2

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

Time frame
Baseline/T0 (recruitment, normally day 1 of inpatient stay and maximum of day 7), T1 (end of inpatient stay ± 7 d, normally 7 days up to 50 weeks), Follow-Up/T2 (three months after clinical discharge ± 7 d); measured T0 to T1 and T0 to T2 and T1 to T2
3

Blood markers (metabolic, HbA1c)

HbA1c \[%\], higher values (\> 5.7%) represent unfavorable metabolic risk

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

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

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

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