NCT03735576

Cognitive Behavioural Therapy for the Treatment of Late Life Depression

Cognitive Behavioural Therapy for the Treatment of Late Life Depression - a Multicentre, Randomized, Observer- Blinded, Controlled Trial (CBTlate)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Late-life Depression
• Major Depressive Disorder
• Major Depressive Episode
• Major Depressive Disorder, Recurrent

Interventions

Type	Name	Description
BEHAVIORAL	Psychotherapy	15-session individually-delivered CBT specific for LLD in comparison with a supportive unspecific intervention (SUI) of the same quantity
DIAGNOSTIC_TEST	Questionnaires	There will be a total of four assessments (see primary \& secondary endpoints). The first visit of the study will be a screening and baseline (T0) visit. After the baseline assessment, the subjects will be randomized to either of the two treatment arms. Within one week, the first of the successive bi-weekly 50-minute individual face-to-face treatment sessions will be performed by a study therapist. After 7 therapy sessions, the primary and secondary outcomes will be obtained in week 5 (T1) by the blinded rater. This will be followed by the treatment sessions 8 to 15 which will be carried out by the therapist. End-of-treatment primary and secondary outcomes will be obtained in week 10 (T2). The final follow-up assessment (T3) will be performed 6 months after randomization by the blinded rater.
OTHER	Magnetic Resonance Imaging	Underlying mechanisms are examined using neuroimaging. MRI data are acquired at four scanning sites and will be performed at baseline, end-of-treatment and follow-up to obtain a high-resolution structural T1-weighted image, a T2-weighted FLAIR image, a resting state fMRI, and diffusion tensor imaging (DTI) of the subjects' brain.
OTHER	Blood analysis	Blood sampling will be acquired in order to investigate the underlying mechanisms in LLD and the specific effects of psychotherapy. Blood samples are acquired at five sites at baseline (T0), T1, T2 and T3 for genetic and epigenetic analyses, measurement of Amyloid-β, Neurofilament light chain (NFL), Peripheral Blood Mononuclear Cells (PBMCs), Metabolomics, Proteomics and miRNA analyses.

Timeline

• Start date: 2017-10-01
• Primary completion: 2021-05-11
• Completion: 2021-05-11
• First posted: 2018-11-08
• Last updated: 2022-05-20

Locations

7 sites across 1 country: Germany