Cognitive Behavioural Therapy for the Treatment of Late Life Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder, Recurrent; Major Depressive Episode; Late-life Depression; Major Depressive Disorder

• Registration Number: NCT03735576
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-08
• Primary Completion: 2021-05-11
• Study Completion: 2021-05-11
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of Geriatric Depression Scale (GDS) Score	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.

Secondary Outcome Measures

Name	Time	Method
Change of Geriatric Anxiety Inventory (GAI) Score	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.
Change in Quality of Life (WHOQOL)	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.
Change of Geriatric Depression Scale (GDS) Score	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.
Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)	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.
Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score	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.
Longitudinal Interval Follow-up Evaluation (LIFE)	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.
Change of Insomnia Severity Index (ISI) Score	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.
Change in cognitive function (CERAD-Plus)	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.
Change in Subjective Cognitive Functioning	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.
Childhood Trauma Questionnaire (CTQ)	baseline	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)	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.
Change of Epworth Sleepiness Scale (ESS) Score	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.
Change in Short Form Health Survey (SF-36)	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).
Change in executive function (NAB maze test)	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.
Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score	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.

Trial Locations

Locations (7)

Charité Berlin; 🇩🇪 Berlin, Germany

University of Bonn; 🇩🇪 Bonn, Germany

University of Cologne; 🇩🇪 Cologne, Germany

University of Freiburg; 🇩🇪 Freiburg, Germany

University of Leipzig; 🇩🇪 Leipzig, Germany

ZI Mannheim; 🇩🇪 Mannheim, Germany

University of Tuebingen; 🇩🇪 Tuebingen, Germany