F32 F33
Conditions
Interventions
Group 1: Morning bright-light therapy will be apply for 2 weeks (10 sessions of 30 minutes each) with "active" light (10000 lux) in addition to standard treatment of depression "treatment as usual" (T
Sponsors
Vitos - Klinikum Gießen und MarburgÄrztlicher Direktor
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: F32- Major depressive Episode F33- Recurrent depressive disorder
Exclusion criteria
Exclusion criteria: (1) Important somatic comorbidity (2) Endocrine diseases (especially of the adrenal Cortex, thyroid hyper- or hypofunction), (3) Recent (within the last four weeks) disruptions of sleep-wake rhythmicity due to exogenous conditions such as shift work or travel across time zones with jet lag. (4) Marked suicidal ideation or severe agitation (5) No capacity of discernment (6) Diseases of the the eye (7) Mental disorders of the ICD-10 groups F0, F1 (except F17), F5-F7. (8) Neurological diseases with severe somatosensory deficits, (9) Organic sleep disoders, ( 10) Current or recent (3 months at maximum) treatment with steroids (except contraceptives), (11) Pregnancy,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean improvement in the Hamilton Scale for Depression scores from T0 (Baseline) to T2 (after 2 weeks)) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Sleep (subjective, Pittsburgh Sleep Quality Index, PSQI) Baseline (T0), after 1 week (T1), after 2 weeks (T2) (2) Circadian rhythmicity (actigraphically measured sleep Parameters, rest-activity rhythmicity (Ratio between activity and inactivity state, the so-called relative Amplitude; for 3 days at Baseline (T0), after 1 week (T1), after 2 weeks (T2); Questionnaire: Morningness-Eveningness-Questionnaire, D-MEQ; Baseline (T0) (3) Biological parameters of circadian rhythmicity (cortisol awakening response: saliva samples and Melatonin (saliva samples) evening (one sample) and subsequent morning (four times within 60 minutes) at Baseline (T0), after 1 week (T1), after 2 weeks (T2) (4) Cognition (Montreal-Cognitive-Assessment, MoCA). Declarative memory (Nürnberger Altersinventar - subtest word list (NAI-WL) at Baseline (T0), after 1 week (T1), after 2 weeks (T2) evening (1 test) subsequent morning (1 test) (5) Quality and intensity of pain (Questionnaire of pain Quality and processing (FB); measures of pain sensitivity: pressure pain thresholds at Baseline (T0), after 1 week (T1), after 2 weeks (T2) morning and evening (1 test) (6) Serum- BDNF (Brain-derived neurotrophic factor) Baseline (T0), after 1 week (T1), after 2 weeks (T2) (7) Inflammation Parameter CRP (serum) Baseline (T0), after 1 week (T1), after 2 weeks (T2) (8) Oxytocin (saliva samples) Baseline (T0), after 1 week (T1), after 2 weeks (T2) (9) Depression/anxiety (Hospital Anxiety Depression Scale) Baseline (T0), after 1 week (T1), after 2 weeks (T2) Baseline (T0), after 1 week (T1), after 2 weeks (T2) (10) Current mood state (Positive and Negative Affect Schedule, PANAS-D) Baseline (T0), after 1 week (T1), after 2 weeks (T2) Secondary endpoints are defiend from Baseline T0 to T2 (after 2 weeks) | — |
Countries
Germany
Contacts
Public ContactNicole Cabanel
Vitos Klinik für Psychiatrie und Psychotherapie Gießen
Outcome results
None listed