- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03735576
Cognitive Behavioural Therapy for the Treatment of Late Life Depression (CBTlate)
May 19, 2022 updated by: Frank Jessen, University of Cologne
Cognitive Behavioural Therapy for the Treatment of Late Life Depression - a Multicentre, Randomized, Observer- Blinded, Controlled Trial (CBTlate)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany
- Charite Berlin
-
Bonn, Germany
- University of Bonn
-
Cologne, Germany
- University of Cologne
-
Freiburg, Germany
- University of Freiburg
-
Leipzig, Germany
- University of Leipzig
-
Mannheim, Germany
- ZI Mannheim
-
Tuebingen, Germany
- University of Tuebingen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
58 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LLD-adapted cognitive behavioural therapy (CBT)
manualized 15-session individually-delivered cognitive behavioural therapy (CBT) specific for late life depression (LLD)
|
15-session individually-delivered CBT specific for LLD in comparison with a supportive unspecific intervention (SUI) of the same quantity
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.
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 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.
|
Active Comparator: supportive unspecific intervention (SUI)
manualized 15-session individually-delivered supportive unspecific intervention (SUI)
|
15-session individually-delivered CBT specific for LLD in comparison with a supportive unspecific intervention (SUI) of the same quantity
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.
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Geriatric Depression Scale (GDS) Score
Time Frame: 10 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Geriatric Depression Scale (GDS) Score
Time Frame: 5 weeks
|
A secondary outcome measure is the change in depression severity from baseline to week 5 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.
|
5 weeks
|
Change of Geriatric Depression Scale (GDS) Score
Time Frame: 6 months
|
A secondary outcome measure is the change in depression severity from baseline to month 6 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.
|
6 months
|
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
Time Frame: 5 weeks
|
A secondary outcome measure is the change in depression severity from baseline to week 5 measured by the 16-item Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C).
It is a clinician-rated scale including 16 Items and a total score range from 0 to 27.
Higher values represent worse outcome.
|
5 weeks
|
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
Time Frame: 10 weeks
|
A secondary outcome measure is the change in depression severity from baseline to week 10 measured by the 16-item Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C).
It is a clinician-rated scale including 16 Items and a total score range from 0 to 27.
Higher values represent worse outcome.
|
10 weeks
|
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
Time Frame: 6 months
|
A secondary outcome measure is the change in depression severity from baseline to month 6 measured by the 16-item Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C).
It is a clinician-rated scale including 16 Items and a total score range from 0 to 27.
Higher values represent worse outcome.
|
6 months
|
Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score
Time Frame: 10 weeks
|
A secondary outcome measure is the change in depression severity from baseline to week 10 measured by the 35-item Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score.
It is a self-rating scale including 35 Items on an11-point numeric rating scale.
Higher values represent worse outcome.
|
10 weeks
|
Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score
Time Frame: 6 months
|
A secondary outcome measure is the change in depression severity from baseline to month 6 measured by the 35-item Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score.
It is a self-rating scale including 35 Items on an11-point numeric rating scale.
Higher values represent worse outcome.
|
6 months
|
Longitudinal Interval Follow-up Evaluation (LIFE)
Time Frame: 6 months
|
A secondary outcome measure is the longitudinal evaluation of depressive symptoms by the Longitudinal Interval Follow-up Evaluation Interview (LIFE) at month 6.
|
6 months
|
Change of Insomnia Severity Index (ISI) Score
Time Frame: 10 weeks
|
A secondary outcome measure is the change in insomnia severity from baseline to week 10 measured by the 7-item Insomnia Severity Index (ISI).
It is a self-rating scale including 7 Items rated on a scale from 0 to 4 from less to more severe.
The total score ranges from 0 to 28.
Higher values represent worse outcome.
|
10 weeks
|
Change of Insomnia Severity Index (ISI) Score
Time Frame: 6 months
|
A secondary outcome measure is the change in insomnia severity from baseline to month 6 measured by the 7-item Insomnia Severity Index (ISI).
It is a self-rating scale including 7 Items rated on a scale from 0 to 4 from less to more severe.
The total score ranges from 0 to 28.
Higher values represent worse outcome.
|
6 months
|
Change of Epworth Sleepiness Scale (ESS) Score
Time Frame: 10 weeks
|
A secondary outcome measure is the change in sleepiness from baseline to week 10 measured by the 8-item Epworth Sleepiness Scale (ESS).
It is a self-rating scale including 8 Items rated on a 4-point Likert scale.
The total score ranges from 0 to 24.
Higher values represent worse outcome.
|
10 weeks
|
Change of Epworth Sleepiness Scale (ESS) Score
Time Frame: 6 months
|
A secondary outcome measure is the change in sleepiness from baseline to month 6 measured by the 8-item Epworth Sleepiness Scale (ESS).
It is a self-rating scale including 8 Items rated on a 4-point Likert scale.
The total score ranges from 0 to 24.
Higher values represent worse outcome.
|
6 months
|
Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score
Time Frame: 10 weeks
|
A secondary outcome measure is the change in REM sleep behavior from baseline to week 10 measured by the 10-item REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ).
It is a self-rating scale including 10 Items in a yes/no format.
The total score ranges from 0 to 13.
Higher values represent worse outcome.
|
10 weeks
|
Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score
Time Frame: 6 months
|
A secondary outcome measure is the change in REM sleep behavior from baseline to month 6 measured by the 10-item REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ).
It is a self-rating scale including 10 Items in a yes/no format.
The total score ranges from 0 to 13.
Higher values represent worse outcome.
|
6 months
|
Change of Geriatric Anxiety Inventory (GAI) Score
Time Frame: 10 weeks
|
A secondary outcome measure is the change in anxiety symptoms from baseline to week 10 measured by the 20-item Geriatric Anxiety Inventory (GAI).
It is a self-rating scale including 20 Items in a agree/disagree format and a total score range from 0 to 20.
The cut-off score of 9 classifies the presence of clinically significant anxiety.
Higher values represent worse outcome.
|
10 weeks
|
Change of Geriatric Anxiety Inventory (GAI) Score
Time Frame: 6 months
|
A secondary outcome measure is the change in anxiety symptoms from baseline to month 6 measured by the 20-item Geriatric Anxiety Inventory (GAI).
It is a self-rating scale including 20 Items in a agree/disagree format and a total score range from 0 to 20.
The cut-off score of 9 classifies the presence of clinically significant anxiety.
Higher values represent worse outcome.
|
6 months
|
Change in Quality of Life (WHOQOL)
Time Frame: 10 weeks
|
A secondary outcome measure is the change in quality of life from baseline to week 10 measured by the 24-item WHOQOL-OLD and 26-item WHOQOL-BREF.
|
10 weeks
|
Change in Quality of Life (WHOQOL)
Time Frame: 6 months
|
A secondary outcome measure is the change in quality of life from baseline to month 6 measured by the 24-item WHOQOL-OLD and 26-item WHOQOL-BREF.
|
6 months
|
Change in Short Form Health Survey (SF-36)
Time Frame: 10 weeks
|
A secondary outcome measure is the change in overall health status from baseline to week 10 measured by the 36-item Short Form Health Survey (SF-36).
|
10 weeks
|
Change in Short Form Health Survey (SF-36)
Time Frame: 6 months
|
A secondary outcome measure is the change in overall health status from baseline to month 6 measured by the 36-item Short Form Health Survey (SF-36).
|
6 months
|
Change in Subjective Cognitive Functioning
Time Frame: 6 months
|
A secondary outcome measure is the change in subjective cognitive functioning from baseline to month 6 measured by the semi-structured Subjective Cognitive Decline interview.
|
6 months
|
Change in cognitive function (CERAD-Plus)
Time Frame: 6 months
|
A secondary outcome measure is the change in cognitive function from baseline to month 6 measured by the Consortium to Establish a Registry for Alzheimer's Disease (CERAD-Plus) neuropsychological test battery.
|
6 months
|
Change in executive function (NAB maze test)
Time Frame: 6 months
|
A secondary outcome measure is the change in executive function from baseline to month 6 measured by the Neuropsychological Assessment Battery (NAB) maze subtest.
|
6 months
|
Childhood Trauma Questionnaire (CTQ)
Time Frame: baseline
|
Assessment of the severity of five categories of childhood trauma(emotional/physical/sexual abuse and emotional/physical neglect) at baseline
|
baseline
|
Big Five-Inventory 10 Item Short Version (BFI-10)
Time Frame: baseline
|
10-item scale measuring the personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness to assess the influence of personality traits on treatment outcome at baseline.
The items are rated on a five-step scale from 1 "disagree strongly" to 5 "agree strongly".
The scale consists of 2 BFI items for each Big Five Dimension.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frank Jessen, Prof.Dr., University of Cologne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Actual)
May 11, 2021
Study Completion (Actual)
May 11, 2021
Study Registration Dates
First Submitted
October 24, 2018
First Submitted That Met QC Criteria
November 6, 2018
First Posted (Actual)
November 8, 2018
Study Record Updates
Last Update Posted (Actual)
May 20, 2022
Last Update Submitted That Met QC Criteria
May 19, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01KG1716
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on Psychotherapy
-
Universidade Federal do Rio de JaneiroCompleted
-
Randi UlbergUniversity of OsloCompleted
-
Hopital MontfortThe Ottawa HospitalCompletedDepression | Parkinson's DiseaseCanada
-
Marianne Lau, MD, DSci.The Ministry of Science, Technology and Innovation, DenmarkUnknownBulimia Nervosa (BN) | Binge Eating Disorder (BED) | Eating Disorder Not Otherwise Specified (EDNOS)Denmark
-
University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Completed
-
University Hospital FreiburgCompletedChronic Major Depressive DisorderGermany
-
Centre Hospitalier Régional Metz-ThionvilleCentral Hospital, Nancy, France; University of LorraineCompletedBreast Cancer FemaleFrance
-
Oslo University HospitalSouth-Eastern Norway Regional Health AuthorityUnknown
-
Memorial Sloan Kettering Cancer CenterUniversity of Manitoba; National Cancer Institute (NCI); Visiting Nurse Service... and other collaboratorsCompleted
-
Weill Medical College of Cornell UniversityUnknownIdentity Pathology | Behavior ProblemsUnited States