跳至主要内容
临床试验/NCT02281175
NCT02281175已完成不适用

The Effectiveness of a Novel Psychosocial Intervention "Programme d'Aide au Succès du Sevrage " (PASSE-65+) Designed to Help Older Benzodiazepine Users to Gradually Wean Their Medication

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
114
试验地点
2
主要终点
Change in consumed BZD (diazepam equivalent) dose

研究概览

简要总结

Benzodiazepines (BZD) are widely used to treat anxiety, insomnia, and depression. These drugs can have very serious side effects if they are taken over a long period of time. In addition to stability, memory, concentration, vigilance, and attention impairments, long-term use of BZD is also associated with an increased in hypertension incidence, urinary incontinence, coronary artery disease, and renal complications. There are growing evidences that long-term BZD use causes physical and psychological dependence as evidenced by the withdrawal syndrome.

The recommended strategy by physicians to facilitate the withdrawal of BZD is to gradually reduce the medication, either by replacing the BZD by another with a longer half-life, or by the gradual dose reduction. Unfortunately, the success of such a procedure is low as up to 80% of people who try to quit, relapse due to the intolerance of withdrawal symptoms. Therefore, it is important to find new strategies to overcome the withdrawal difficulties.

The aim of this study is to test the effectiveness of a novel psychosocial intervention called PASSE-65+ to facilitate the benzodiazepine withdrawal in the older users, thus providing a new therapeutic tool to physician.

详细描述

Benzodiazepines (BZD) represent the most frequently consumed drugs by the elderly persons in Canada. Indeed, there is 7.5 times more BZD users in older people (65 years and over) than in adults (18-64 years). Importantly, more than 50% of seniors who received a prescription of BZD do not display any severe psychiatric symptoms and are physically in good health.

Results from a survey including 2811 community-dwelling older adults (65 years and over) showed that 32% of the respondents consumed BZD for an average of 205 days and 60% of them had at least received one potentially inappropriate prescription during this period (e.g. a prescription of a BZD with a long half-life or a prescription of 2 BZD for more than 6 consecutive weeks, etc.). Another study showed that 45% of new BZD users take these drugs for more than 30 days. It should be noted that the definition of a long-term BZD use varies from three to four months of consumption, which corresponds to the average period used by almost all seniors.

Long-term use of BZD by older people is a complex phenomenon that can be explained by several personal, psychological, and social factors interacting with each other. Systemic model of BZD consumption in late-life implies the following five elements which contribute to initiate and maintain BZD taking: 1) history (i.e. autonomy loss, stress, disease apparition, etc.); 2) the prescription process; 3) personal dispositions (i.e. sexe, age, education, loneliness, etc.); 4) sociocultural factors (i.e. positive attitude of their family or their physician toward BZD use); and 5) cognitive strategies (e.g. trivialization of concerns about the drugs, etc.).

To the researcher's knowledge, very few randomized controlled clinical trials have tested the effectiveness of non-pharmacological interventions in patients with a mean age of 60 years and older. Data from these studies showed that brief intervention (e.g. receiving either an informative leaflet on BZD withdrawal during a meeting with the doctor or an informative letter by post mail) or psychological interventions (including cognitive behavioral therapy or CBT) are most likely more effective than the standard care and in some cases, to the gradual dose reduction (GDR) supervised by a physician. However, only 10% (brief intervention) to 85% (cognitive behavioral therapy designed to treat insomnia) of participants completely stopped BZD use at the end of treatment. Furthermore, Parr and colleagues indicate that the complete stop of BZD consumption remains difficult and still a big challenge to patients, clinicians and researchers.

Nevertheless, one of the limitations of these studies is the large variation of age of their participants (ranging from 18 to 85 years, despite a mean age of over 60 years), thus restricting the generalization of the findings to older patients. Moreover, these results derive from efficacy studies (vs effectiveness studies) designed to improve internal validity at the expense of external validity. Although these results demonstrate the potential efficacy (vs effectiveness) of non-pharmacological treatments to facilitate BZD withdrawal, very few elderly users receive such interventions due to lack of resources, expertise and time or simply due to their expensive implementation cost. Finally, to the investigator's knowledge, no psychosocial intervention based on cognitive-behavioral therapy (CBT) and including other specific personal, psychological, and social components associated to aging, and targeting older people with different psychological problems (i.e. not only insomnia but also anxiety or depression) has been tested. Therefore, the researcher hypothesized that the "Programme d'Aide au Succès du SEvrage (PASSE-65+)" could be more suitable and effective to help older people in their BZD withdrawal management.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be aged 65 years and older;
  • To consume benzodiazepine for at least two years (even if consumption is not continuous);
  • Want to quit benzodiazepine use.

排除标准

  • Living a difficult situation that requires specific interventions (e.g. bereavement or death, a recent breakup or suicidal thoughts);
  • Alcohol or illicit drugs addiction (other than benzodiazepine);
  • BZD use for medical reasons (e.g. epilepsy);
  • Be unable to complete the questionnaires or to attend meetings for any reason (e.g. Loss of vision, severe arthritis, cognitive impairment, etc.).

结局指标

主要结局

Change in consumed BZD (diazepam equivalent) dose

时间窗: 1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments)

Comparison between the average dose of BZD (diazepam equivalent) consumed during the month preceding the beginning of intervention and the one consumed between 2-14 days , 3 months and 12 months after the end of intervention.

次要结局

  • Assessment of withdrawal symptoms(1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments))
  • Evaluation of self-competence OU self-confidence towards change in benzodiazepine use(1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments))
  • Estimation of attitudes towards benzodiazepine consommation(1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments))
  • Measurement of depression symptoms(1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments))
  • Symptoms of anxiety OU worry assessment(1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments))
  • Assessment of sleep quality(1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments))

研究者

发起方
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Sébastien Grenier

Research Associate Professor

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

研究点 (2)

Loading locations...

相似试验