Cognitive Behavioural Therapy for the Treatment of Late Life Depression - a Multicentre, Randomized, Observer- Blinded, Controlled Trial (CBTlate)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 9
- 主要终点
- Change of Geriatric Depression Scale (GDS) Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Bipolar depression
- •Schizophrenia or other psychotic disorders
- •Substance abuse or dependency
- •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)
结局指标
主要结局
Change of Geriatric Depression Scale (GDS) Score
时间窗: 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.
次要结局
- Change of Geriatric Anxiety Inventory (GAI) Score(6 months)
- Change in Quality of Life (WHOQOL)(6 months)
- Change of Geriatric Depression Scale (GDS) Score(6 months)
- Change of Quick Inventory of Depressive Symptomatology Score - Clinician Rating (QIDS-C)(6 months)
- Change of Patient Reported Outcome for Major Depressive Disorder (PRO-MDD) Score(6 months)
- Longitudinal Interval Follow-up Evaluation (LIFE)(6 months)
- Change of Insomnia Severity Index (ISI) Score(6 months)
- Big Five-Inventory 10 Item Short Version (BFI-10)(baseline)
- Change of Epworth Sleepiness Scale (ESS) Score(6 months)
- Change in Short Form Health Survey (SF-36)(6 months)
- Change in cognitive function (CERAD-Plus)(6 months)
- Change in executive function (NAB maze test)(6 months)
- Change of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)Score(6 months)
- Change in Subjective Cognitive Functioning(6 months)
- Childhood Trauma Questionnaire (CTQ)(baseline)
研究者
Frank Jessen
Prof. Dr.
University of Cologne