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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Psychotherapy
Questionnaires
Magnetic Resonance Imaging
Blood analysis
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Late-life Depression focused on measuring Late-life depression, Psychotherapy, Major depression, Randomized controlled trial, Treatment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Charité Berlin
  • University of Bonn
  • University of Cologne
  • University of Freiburg
  • University of Leipzig
  • ZI Mannheim
  • University of Tuebingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LLD-adapted cognitive behavioural therapy (CBT)

supportive unspecific intervention (SUI)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of Geriatric Depression Scale (GDS) Score
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.
Change of Geriatric Depression Scale (GDS) Score
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.
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
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.
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
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.
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
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.
Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score
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.
Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score
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.
Longitudinal Interval Follow-up Evaluation (LIFE)
A secondary outcome measure is the longitudinal evaluation of depressive symptoms by the Longitudinal Interval Follow-up Evaluation Interview (LIFE) at month 6.
Change of Insomnia Severity Index (ISI) Score
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.
Change of Insomnia Severity Index (ISI) Score
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.
Change of Epworth Sleepiness Scale (ESS) Score
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.
Change of Epworth Sleepiness Scale (ESS) Score
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.
Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score
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.
Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score
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.
Change of Geriatric Anxiety Inventory (GAI) Score
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.
Change of Geriatric Anxiety Inventory (GAI) Score
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.
Change in Quality of Life (WHOQOL)
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.
Change in Quality of Life (WHOQOL)
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.
Change in Short Form Health Survey (SF-36)
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).
Change in Short Form Health Survey (SF-36)
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).
Change in Subjective Cognitive Functioning
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.
Change in cognitive function (CERAD-Plus)
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.
Change in executive function (NAB maze test)
A secondary outcome measure is the change in executive function from baseline to month 6 measured by the Neuropsychological Assessment Battery (NAB) maze subtest.
Childhood Trauma Questionnaire (CTQ)
Assessment of the severity of five categories of childhood trauma(emotional/physical/sexual abuse and emotional/physical neglect) at baseline
Big Five-Inventory 10 Item Short Version (BFI-10)
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.

Full Information

First Posted
October 24, 2018
Last Updated
May 19, 2022
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT03735576
Brief Title
Cognitive Behavioural Therapy for the Treatment of Late Life Depression
Acronym
CBTlate
Official Title
Cognitive Behavioural Therapy for the Treatment of Late Life Depression - a Multicentre, Randomized, Observer- Blinded, Controlled Trial (CBTlate)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
May 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Late-life Depression, Major Depressive Disorder, Major Depressive Episode, Major Depressive Disorder, Recurrent
Keywords
Late-life depression, Psychotherapy, Major depression, Randomized controlled trial, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LLD-adapted cognitive behavioural therapy (CBT)
Arm Type
Experimental
Arm Description
manualized 15-session individually-delivered cognitive behavioural therapy (CBT) specific for late life depression (LLD)
Arm Title
supportive unspecific intervention (SUI)
Arm Type
Active Comparator
Arm Description
manualized 15-session individually-delivered supportive unspecific intervention (SUI)
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
15-session individually-delivered CBT specific for LLD in comparison with a supportive unspecific intervention (SUI) of the same quantity
Intervention Type
Diagnostic Test
Intervention Name(s)
Questionnaires
Intervention Description
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
Other
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
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
Intervention Name(s)
Blood analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Geriatric Depression Scale (GDS) Score
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Change of Geriatric Depression Scale (GDS) Score
Description
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.
Time Frame
5 weeks
Title
Change of Geriatric Depression Scale (GDS) Score
Description
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.
Time Frame
6 months
Title
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
Description
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.
Time Frame
5 weeks
Title
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
Description
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.
Time Frame
10 weeks
Title
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
Description
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.
Time Frame
6 months
Title
Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score
Description
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.
Time Frame
10 weeks
Title
Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score
Description
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.
Time Frame
6 months
Title
Longitudinal Interval Follow-up Evaluation (LIFE)
Description
A secondary outcome measure is the longitudinal evaluation of depressive symptoms by the Longitudinal Interval Follow-up Evaluation Interview (LIFE) at month 6.
Time Frame
6 months
Title
Change of Insomnia Severity Index (ISI) Score
Description
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.
Time Frame
10 weeks
Title
Change of Insomnia Severity Index (ISI) Score
Description
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.
Time Frame
6 months
Title
Change of Epworth Sleepiness Scale (ESS) Score
Description
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.
Time Frame
10 weeks
Title
Change of Epworth Sleepiness Scale (ESS) Score
Description
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.
Time Frame
6 months
Title
Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score
Description
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.
Time Frame
10 weeks
Title
Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score
Description
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.
Time Frame
6 months
Title
Change of Geriatric Anxiety Inventory (GAI) Score
Description
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.
Time Frame
10 weeks
Title
Change of Geriatric Anxiety Inventory (GAI) Score
Description
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.
Time Frame
6 months
Title
Change in Quality of Life (WHOQOL)
Description
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.
Time Frame
10 weeks
Title
Change in Quality of Life (WHOQOL)
Description
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.
Time Frame
6 months
Title
Change in Short Form Health Survey (SF-36)
Description
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).
Time Frame
10 weeks
Title
Change in Short Form Health Survey (SF-36)
Description
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).
Time Frame
6 months
Title
Change in Subjective Cognitive Functioning
Description
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.
Time Frame
6 months
Title
Change in cognitive function (CERAD-Plus)
Description
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.
Time Frame
6 months
Title
Change in executive function (NAB maze test)
Description
A secondary outcome measure is the change in executive function from baseline to month 6 measured by the Neuropsychological Assessment Battery (NAB) maze subtest.
Time Frame
6 months
Title
Childhood Trauma Questionnaire (CTQ)
Description
Assessment of the severity of five categories of childhood trauma(emotional/physical/sexual abuse and emotional/physical neglect) at baseline
Time Frame
baseline
Title
Big Five-Inventory 10 Item Short Version (BFI-10)
Description
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.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Jessen, Prof.Dr.
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Berlin
City
Berlin
Country
Germany
Facility Name
University of Bonn
City
Bonn
Country
Germany
Facility Name
University of Cologne
City
Cologne
Country
Germany
Facility Name
University of Freiburg
City
Freiburg
Country
Germany
Facility Name
University of Leipzig
City
Leipzig
Country
Germany
Facility Name
ZI Mannheim
City
Mannheim
Country
Germany
Facility Name
University of Tuebingen
City
Tuebingen
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
31881995
Citation
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.
Results Reference
derived

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Cognitive Behavioural Therapy for the Treatment of Late Life Depression

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