Cognitive behavioural therapy for the treatment of late life depression – a multicentre, randomized, observer- blinded, controlled trial (CBTlate)

Phase 3

Recruiting

• Conditions: F32; F33; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00013769
• Lead Sponsor: niversitätsklinikum Köln Klinik für Psychiatrie und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 248

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

• 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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is the change in Geriatric Depression Scale (GDS, range 0-30) from baseline (T0) to end-of-treatment (T2).