F32 F33
Conditions
Interventions
Group 1: LLD-adapted cognitive behavioural therapy (CBT), 15 therapy sessions (50 min each), Questionnaires (see primary & secondary endpoints) at four time points (T0 baseline, T1 mid of treatment, T
Sponsors
Universitätsklinikum Köln Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. out-patient status 2. male/ female, age = 60 years inclusive at screening 3. depressive episode (moderate to severe according to ICD-10) 4. Geriatric Depression Scale (GDS) > 10 5. Quick Inventory of Depressive Symptomatology (QIDS-C > 10) 6. MMSE > 25 points 7. no or stable (= 6 weeks) antidepressive pharmacological treatment at baseline and stable antidepressive pharmacological treatment during 8-week intervention 8. sufficient German language skills 9. written informed consent signed
Exclusion criteria
Exclusion criteria: • Bipolar depression • Schizophrenia • Other psychotic disorders • Substance abuse or dependency • Dementia • Acute suicidality • Anxiety disorder as stand-alone diagnosis (e.g. generalized anxiety disorder, panic disorder, phobia) • Obsessive-compulsive disorder as stand-alone diagnosis • Participation in another trial of psychotherapeutic/psychiatric intervention parallel to this trial • Additional psychological/ psychotherapeutic treatment throughout the study including the follow- up visit • Regular use with scheduled dosing of Benzodiazepines (not PRN) • Severe or instable medical condition, which clearly impacts on depression or on the ability to participate in the trial • Brain disease with severe functional impairement that impacts the ability to participate in the trial (e.g. aphasia, Parkinson’s disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the change in Geriatric Depression Scale (GDS, range 0-30) from baseline (T0) to end-of-treatment (T2). | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary endpoints are the change in Geriatric Depression Scale (GDS) from baseline (T0) to end of follow-up (T3) as well as changes from baseline to end-of-treatment (T2) and to end of follow-up (T3; 6 months after randomization) in: • Quick Inventory of Depressive Symptomatology (QIDS-C) • Geriatric Anxiety Inventory (GAI) • Patient-Reported Outcome in Major Depressive Disorder (PRO-MDD) • WHO Quality of Life (WHOQOL-OLD, WHOQOL-BREF) • Health Status (SF 36) • Insomnia Severity Index (ISI) • Epworth Sleepiness Scale (ESS) • REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) • Consortium to Establish a Registry for Alzheimer's Disease neuropsychological battery (CERADplus) • Subtests of the Screening Module (Executive Funtions: Mazes, Planning; Attention: Digits Forward, Digits Backward) of the Neuropsychological Assessment Battery (NAB) • Childhood Trauma Questionnaire (CTQ-SF) • Big Five Inventory-10 (BFI-10) The longitudinal evaluation of depressive symptoms will be conducted at follow-up by assessing the outcomes in the Longitudinal Interval Follow-up Evaluation (LIFE). | — |
Countries
Germany
Contacts
Public ContactForugh Dafsari
Universitätsklinikum Köln Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed