Randomised Monocentric Clinical Study for the Identification of Cognitive and Neuroanatomical Alterations and for the Evaluation of the Efficacy of a Psychotherapeutic Intervention in Individuals With Risky Consumption of Alcohol and/or Sedative Drugs Aged ≥ 65 Years
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- change in the total score of the Hospital Anxiety and Depression Scale - German version (HADS-D)
研究概览
简要总结
The prevalence of addictive disorders in old age is increasing. Age specific and appropriate therapeutic concepts tailored to in-patients thus represent a promising approach for the future. The investigated therapeutic intervention is a "therapy program for integrated qualified acute treatment of alcohol and drug problems" (TIQAAM).
详细描述
The prevalence of addictive disorders in old age is increasing. Age specific and appropriate therapeutic concepts tailored to inpatients thus represent a promising approach for the future. The investigated therapeutic intervention is a "therapy program for integrated qualified acute treatment of alcohol and drug problems" (TIQAAM).
Subjects ≥ 65 years, in which according to the WHO ASSIST V3.0 a risky consumption of alcoholic beverages, or benzodiazepines / non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon), or both, are examined before and after a psychotherapeutic intervention during their inpatient stay exists. The data collected in part 1 of the study pertain to social integration, the motivation to change, quality of life in old age, general psychiatric symptoms. The data collected in part 2 of the study pertain to brain structure and functions. Data from standard procedures will be correlated to the data above.These relate to psychiatric symptoms, past consumption behavior, cognitive abilities, perceived social support and risk appetite.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 65 or above with, according to WHO-ASSIST V3.0, a hazardous consumption of alcoholic beverages and / or benzodiazepines and / or non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon)
- •The subjects must be able to understand verbal and written information about the study flow and content and to give their written consent.
- •The subjects must be able to understand and perform verbal and written tasks (cognitive tests / questionnaires)
排除标准
- •Taking medication that could affect cognition outside of benzodiazepines and / or non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon).
- •Drug treatments with anxiolytics (benzodiazepines) as part of an ongoing drug-assisted detoxification
- •Taking antidepressant medication
- •Taking sleep-inducing substances (for example Dipiperon®, Trittico®, Valverde Sleep® or Valverde Entspannung®)
- •Taking other anxiolytic active substances (for example, pregabalin, Opipramol). The use of medication is allowed to treat somatic diseases.
- •Use of drugs or substance dependence. Except for alcohol, benzodiazepines and non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon)
- •Diseases which prevent the subject from giving consent for this study or which impair cooperation in the investigation.
- •Severe and / or unstable physical illness: severe depression, severe mania, delirium, severe cognitive impairment (mini-mental status test < 20/30 points), dementia of the Alzheimer type or other dementias, multiple sclerosis, clinically manifest structural brain damage (eg cerebral hemorrhage, brain tumors, MRI findings by Schulthess clinic)
- •Heavily impaired vision and eye diseases
- •Additional exclusion criteria for part 2 of the study:
- •Pacemaker, implantable cardioverter defibrillator (ICD), neurostimulator, aneurysm clip, prosthetic heart valve, valve prosthesis, metal prosthesis
- •Clips after surgery, metallic bone plates, artificial joints, metal fragments in the body, professional in the metal processing industry, non-removable piercing, ferruginous tattoo ink
- •Pregnancy
- •Claustrophobia
- •Use of alcohol or other consciousness-altering substances within 24 hours prior to the MRI scan (exceptions: see "exclusion criteria")
研究组 & 干预措施
TIQAAM_therapy
Individuals in this group will receive units from the TIQAAM treatment program
干预措施: TIQAAM_therapy (Other)
active_control
Individuals in this group will receive units of psychoeducation
干预措施: Psychoeducation (Other)
结局指标
主要结局
change in the total score of the Hospital Anxiety and Depression Scale - German version (HADS-D)
时间窗: 210 days
次要结局
未报告次要终点
研究者
Prof. Dr. med. Egemen Savaskan
Prof. Dr. med.
Psychiatric University Hospital, Zurich