Cognitive Behavioural Therapy for the Treatment of Late Life Depression

NCT ID: NCT03735576

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2021-05-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LLD-adapted cognitive behavioural therapy (CBT)

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

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: BEHAVIORAL

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

Questionnaires

Intervention Type: 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.

Magnetic Resonance Imaging

Intervention Type: 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.

Blood analysis

Intervention Type: 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.

supportive unspecific intervention (SUI)

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

Group Type: ACTIVE_COMPARATOR

Psychotherapy

Intervention Type: BEHAVIORAL

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

Questionnaires

Intervention Type: 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.

Magnetic Resonance Imaging

Intervention Type: 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.

Blood analysis

Intervention Type: 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.

Interventions

Psychotherapy

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Frank Jessen

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Jessen, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

Charité Berlin

Berlin, , Germany

University of Bonn

Bonn, , Germany

University of Cologne

Cologne, , Germany

University of Freiburg

Freiburg im Breisgau, , Germany

University of Leipzig

Leipzig, , Germany

ZI Mannheim

Mannheim, , Germany

University of Tuebingen

Tübingen, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 40669702 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38619842 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31881995 (View on PubMed)

Other Identifiers

01KG1716

Identifier Type: -

Identifier Source: org_study_id