Cognitive Behavioural Therapy for the Treatment of Late Life Depression (CBTlate)

University of Cologne

Status: Completed

Conditions: Late-life Depression; Major Depressive Disorder; Major Depressive Episode; Major Depressive Disorder, Recurrent

Treatments: Diagnostic Test: Questionnaires; Other: Blood analysis; Behavioral: Psychotherapy; Other: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03735576

01KG1716

Details and patient eligibility

About

This study addresses the unmet medical problem of insufficient treatment of late life depression (LLD). Compared with depression in early adulthood, treatment options of LLD are limited. This trial is the first confirmatory multicentre study to test the efficacy of an LLD-adapted cognitive behavioural therapy (CBT) program. It will test the hypothesis, that LLD-specific cognitive behavioural therapy (CBT) is superior to unspecific supportive intervention (SUI) with regard to reducing symptoms of depression over the course of 6 months. Secondary goals are to test the efficacy of LLD-CBT in comparison with SUI on patient reported outcome in major depressive disorders (PRO-MDD), anxiety, cognition, quality of life, overall health status, sleep and global clinical impression.

Enrollment: 250 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• out-patient status
• male or female, age ≥ 60 years
• ability to provide informed consent and written informed consent signed
• DSM-5 diagnosis of a Major Depressive Disorder/MDD (depressive episode at least moderate to severe)
• score of at least 10 on the Geriatric Depression Scale (GDS)
• score of at least 10 on the Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
• score of at least 25 in the Mini-Mental-Status-Test (MMST)
• no or stable (≥ 6 weeks) antidepressive pharmacological treatment at baseline (medication will be kept stable at least throughout the 8 weeks of treatment).
• sufficient German language skills

Exclusion criteria

• Bipolar depression
• Schizophrenia or other psychotic disorders
• Substance abuse or dependency
• Dementia
• Acute suicidality
• Anxiety disorder as stand-alone diagnosis (e.g. generalized anxiety disorder, panic disorder, social phobia)
• Obsessive-compulsive disorder (OCD) as stand-alone diagnosis
• Participation in any another clinical trial parallel to this trial
• Additional psychological/psychotherapeutic treatment throughout the 8-week treatment period
• Regular use with scheduled daily dosing of benzodiazepines (not PRN) during 8-week treatment
• Severe or instable medical condition, which clearly impacts on depression or on the ability to participate in the trial
• Brain disease with severe functional impairment that impacts the ability to participate in the trial (e.g. aphasia, Parkinson's disease)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

LLD-adapted cognitive behavioural therapy (CBT)

Experimental group

Description:

manualized 15-session individually-delivered cognitive behavioural therapy (CBT) specific for late life depression (LLD)

Treatment:

Behavioral: Psychotherapy

Diagnostic Test: Questionnaires

Other: Magnetic Resonance Imaging

Other: Blood analysis

supportive unspecific intervention (SUI)

Active Comparator group

Description:

manualized 15-session individually-delivered supportive unspecific intervention (SUI)

Treatment:

Behavioral: Psychotherapy

Diagnostic Test: Questionnaires

Other: Magnetic Resonance Imaging

Other: Blood analysis