Clinical trial NCT03735576: Cognitive Behavioural Therapy for the Treatment of Late Life Depression
Official title: Cognitive Behavioural Therapy for the Treatment of Late Life Depression - a Multicentre, Randomized, Observer- Blinded, Controlled Trial (CBTlate)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change of Geriatric Depression Scale (GDS) Score
timeFrame: 10 weeks
Secondary outcomes:
measure: Change of Geriatric Depression Scale (GDS) Score
timeFrame: 5 weeks
measure: Change of Geriatric Depression Scale (GDS) Score
timeFrame: 6 months
measure: Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
timeFrame: 5 weeks
measure: Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
timeFrame: 10 weeks
measure: Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)
timeFrame: 6 months
measure: Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score
timeFrame: 10 weeks
measure: Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score
timeFrame: 6 months
measure: Longitudinal Interval Follow-up Evaluation (LIFE)
timeFrame: 6 months
measure: Change of Insomnia Severity Index (ISI) Score
timeFrame: 10 weeks
measure: Change of Insomnia Severity Index (ISI) Score
timeFrame: 6 months
measure: Change of Epworth Sleepiness Scale (ESS) Score
timeFrame: 10 weeks
measure: Change of Epworth Sleepiness Scale (ESS) Score
timeFrame: 6 months
measure: Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score
timeFrame: 10 weeks
measure: Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score
timeFrame: 6 months
measure: Change of Geriatric Anxiety Inventory (GAI) Score
timeFrame: 10 weeks
measure: Change of Geriatric Anxiety Inventory (GAI) Score
timeFrame: 6 months
measure: Change in Quality of Life (WHOQOL)
timeFrame: 10 weeks
measure: Change in Quality of Life (WHOQOL)
timeFrame: 6 months
measure: Change in Short Form Health Survey (SF-36)
timeFrame: 10 weeks
measure: Change in Short Form Health Survey (SF-36)
timeFrame: 6 months
measure: Change in Subjective Cognitive Functioning
timeFrame: 6 months
measure: Change in cognitive function (CERAD-Plus)
timeFrame: 6 months
measure: Change in executive function (NAB maze test)
timeFrame: 6 months
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: baseline
measure: Big Five-Inventory 10 Item Short Version (BFI-10)
timeFrame: baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Berlin
city: Bonn
country: Germany
facility: University of Bonn
city: Cologne
country: Germany
facility: University of Cologne
city: Freiburg
country: Germany
facility: University of Freiburg
city: Leipzig
country: Germany
facility: University of Leipzig
city: Mannheim
country: Germany
facility: ZI Mannheim
city: Tuebingen
country: Germany
facility: University of Tuebingen
Study officials:
affiliation: University of Cologne
name: Frank Jessen, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.