Cognitive Behavioural Therapy for the Treatment of Late Life Depression

NCT03735576 | Completed DMC

• 1 other identifier: 01KG1716
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Late-life depression; Psychotherapy; Major depression; Randomized controlled trial; Treatment

Outcome Measures

Primary Outcomes (1)

• Change of Geriatric Depression Scale (GDS) Score

  The primary end point is the change in depression severity from baseline to week 10 measured by the 30-item Geriatric Depression Scale (GDS). It is a self-rating scale including 30 Items in a yes/no format and a total score range from 0 to 30. Higher values represent worse outcome.

  10 weeks

Secondary Outcomes (25)

• Change of Geriatric Depression Scale (GDS) Score

  5 weeks

• Change of Geriatric Depression Scale (GDS) Score

  6 months

• Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)

  5 weeks

• Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)

  10 weeks

• Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)

  6 months

Study Arms (2)

LLD-adapted cognitive behavioural therapy (CBT)

EXPERIMENTAL

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

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

supportive unspecific intervention (SUI)

ACTIVE COMPARATOR

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

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

Interventions

Psychotherapy BEHAVIORAL

15-session individually-delivered CBT specific for LLD in comparison with a supportive unspecific intervention (SUI) of the same quantity

LLD-adapted cognitive behavioural therapy (CBT); supportive unspecific intervention (SUI)

Questionnaires DIAGNOSTIC_TEST

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.

LLD-adapted cognitive behavioural therapy (CBT); supportive unspecific intervention (SUI)

Magnetic Resonance Imaging OTHER

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.

LLD-adapted cognitive behavioural therapy (CBT); supportive unspecific intervention (SUI)

Blood analysis OTHER

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.

LLD-adapted cognitive behavioural therapy (CBT); supportive unspecific intervention (SUI)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (7)

Charité Berlin

Berlin, Germany

Location

University of Bonn

Bonn, Germany

Location

University of Cologne

Cologne, Germany

Location

University of Freiburg

Freiburg im Breisgau, Germany

Location

University of Leipzig

Leipzig, Germany

Location

ZI Mannheim

Mannheim, Germany

Location

University of Tuebingen

Tübingen, Germany

Location

Related Publications (3)

• Bewernick B, Buschmann J, Heser K, Kleineidam L, Domschke K, Elsaesser M, Zehender N, Luppa M, Hellmich M, Peters O, Froelich L, Riedel-Heller S, Schramm E, Hautzinger M, Jessen F, Dafsari FS, Wagner M. The effect of cognition and age on the efficacy of psychotherapy in late-life depression. J Affect Disord. 2025 Dec 15;391:119881. doi: 10.1016/j.jad.2025.119881. Epub 2025 Jul 14.

  PMID: 40669702 DERIVED

• Dafsari FS, Bewernick B, Bohringer S, Domschke K, Elsaesser M, Lobner M, Luppa M, Schmitt S, Wingenfeld K, Wolf E, Zehender N, Hellmich M, Muller W, Wagner M, Peters O, Frolich L, Riedel-Heller S, Schramm E, Hautzinger M, Jessen F. Perceived Physical Health and Cognitive Behavioral Therapy vs Supportive Psychotherapy Outcomes in Adults With Late-Life Depression: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e245841. doi: 10.1001/jamanetworkopen.2024.5841.

  PMID: 38619842 DERIVED

• Dafsari FS, Bewernick B, Biewer M, Christ H, Domschke K, Froelich L, Hellmich M, Luppa M, Peters O, Ramirez A, Riedel-Heller S, Schramm E, Vry MS, Wagner M, Hautzinger M, Jessen F. Cognitive behavioural therapy for the treatment of late life depression: study protocol of a multicentre, randomized, observer-blinded, controlled trial (CBTlate). BMC Psychiatry. 2019 Dec 27;19(1):423. doi: 10.1186/s12888-019-2412-0.

  PMID: 31881995 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence

Interventions

Psychotherapy; Magnetic Resonance Spectroscopy; Hematologic Tests

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Frank Jessen, Prof.Dr.

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Randomized, multi-center, single blind (observer-blinded), active-controlled, parallel group trial (therapeutic confirmatory) in 248 patients with late-life depression of both genders at 7 trial sites in Germany. The intervention includes 8 weeks of manual-based, individual, 15-session, twice weekly, outpatient treatment for patients with late life depression in each arm of the trial.

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 8, 2018
• Study Start: October 1, 2017
• Primary Completion: May 11, 2021
• Study Completion: May 11, 2021
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

DE (7)