Determinants of Optimal Benzodiazepines Withdrawal in Adults With Hypnotic-dependent Insomnia: a Randomised Controlled Trial Evaluating Acceptance and Commitment Therapy in Telepsychology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Proportion of participants having successfully stopped their benzodiazepine use
研究概览
简要总结
Long-term use of benzodiazepines is a long-standing problem, but the optimal withdrawal modalities are not known. The main objective of this study is to compare the effectiveness of a psychological support versus a psychotherapeutic intervention (Acceptance and Commitment Therapy, ACT) added to a withdrawal program on the reduction of benzodiazepines use in adults suffering from insomnia and hypnotic dependence.
详细描述
Benzodiazepines and related drugs (BZDs) are effective for insomnia and anxiety in the short term. After few months (four weeks regarding insomnia), the benefit/risk ratio is considerably reduced. Nevertheless, between 2 and 5% of the general population uses them for more than 6 months. Prescribing recommendations are unanimous concerning the short-term use of these substances, but do not specify the optimal ways of reducing doses in a withdrawal programme.
Many factors influence the success of withdrawal, including the duration of withdrawal (how quickly doses are reduced), the half-life of the substance, and number of psychological factors. Studies on BZD withdrawal show that, on average, spontaneous cessation of treatment is 5-10%, withdrawal success is 30-40% following brief intervention and 60-80% following Behavioral and Cognitive Therapy (CBT). These are few, and only one study has tested the efficacy of Acceptance and Commitment Therapy (ACT) for benzodiazepine withdrawal. ACT is a contextual behavioral therapy which aims to increase acceptance of the full range of inner experiences including negative thoughts, emotions and sensations, in order to promote values-driven behavior change, leading to an improved quality of life. ACT is notably effective for the treatment of anxiety disorders, depression, psychosis and chronic pain, and some studies have shown the effectiveness of ACT for insomnia.
This study is a four-arms randomized controlled intervention which aims to evaluate the addition to a taper program of an ACT intervention versus a psychological support on one hand, and the duration of withdrawal on the other hand, in patients suffering from hypnotic-dependent insomnia. The entire protocol will be remotely delivered, which no randomized controlled trial has so far evaluated for benzodiazepine withdrawal.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •French speaker
- •Had benzodiazepines and related drugs prescribed to improving sleep, for a minimum of 4 nights per week and for at least 6 months
- •Pathological Benzodiazepine Dependence Questionnaire (BDEPQ) score (>34).
- •Motivated to stop hypnotic treatment (score >5 on a 1 to 10 degrees VAS)
- •Subjective complaints of difficulties initiating and/or maintaining sleep for a minimum of 3 nights per week and for at least 6 months, and 4) presence of marked distress or impaired daytime functioning (fatigue, impaired attention and/or concentration). Because hypnotic medications may mask an underlying insomnia problem, participants should meet these criteria either currently (while taking medication) or after previous attempts to discontinue the medication. These criteria are consistent with those for primary insomnia and hypnotic-dependent insomnia.
- •Present the diagnoses of insomnia (307.42) and sedative, hypnotic and anxiolytic use disorder (304.10) from the DSM V.
- •Having e-literacy (being familiar with emails, videoconferencing, online questionnaires and Internet use)
排除标准
- •In acute treatment for psychological or psychiatric problems (e.g., current participation in psychotherapy)
- •Be participating in a tapering BZD protocol, or similar
- •Currently receiving an active prescription for any antipsychotic medication
- •Using non-BZRA sedative-hypnotics for treating insomnia or related sleep problems (e.g., trazodone, quetiapine, tricyclic antidepressant, mirtazapine, diphenhydramine, dimenhydrinate)
- •Met criteria for a substance use disorder in the last six months (other than nicotine and hypnotics)
- •Use of alcohol or cannabis 3 or more nights a week for sleep problems
- •Drinking more than 3 alcoholic beverages per day
- •Presence of another untreated sleep disorder (e.g., obstructive sleep apnea or periodic limb movements during sleep)
- •Presence of major depression or other severe unstabilized psychopathology (e.g., bipolar disorder, psychosis, panic disorder, generalized anxiety disorder, posttraumatic stress disorder, specific phobia, social phobia, or obsessive-compulsive disorder)
- •Had a history of psychosis
- •Currently suicidal
- •Current crisis or with an illness for which the benzodiazepine were required at the time (e.g. acute pain)
- •Presence of terminal illness (e.g. cancer, receiving palliative care)
- •Unstable cardiovascular, respiratory or endocrinological diseases (clinical interview)
- •Had a history of severe cognitive impairment, dementia, seizure disorder (epilepsy either in themselves or in their family), spinal injury
- •Pregnant or lactating
结局指标
主要结局
Proportion of participants having successfully stopped their benzodiazepine use
时间窗: Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment
Proportion of participants who successfully discontinue benzodiazepines (i.e., no benzodiazepine used for 2 weeks preceding assessment and negative on the urine test for BZD) at 4 weeks posttreatment, 6 months posttreatment, 12 months posttreatment and 24 months posttreatment. Successful discontinuation is defined as completion of the taper schedule without significant deviation and no use of benzodiazepine medications beyond "minimal Pro re nata. use" during the month following the zero-dose date. Minimal BZD use (not considered discontinuation failures): use of no more than 2 Pro Re Nata doses of medication (each not exceeding 0.5 mg diazepam) during the 2 weeks period starting at the zero-dose date. This criterion ensures that taking a minimal P.R.N. dose in extraordinary circumstances will not be considered discontinuation failures.
次要结局
- Benzodiazepines use 1(Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment)
- Sleep Improvement(Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment)
- Psychopathological symptoms improvement(Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment)
- Benzodiazepines use 2(Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment)
- Benzodiazepines dependence(Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment)
- Awareness improvement(Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment)
- Psychological flexibility improvement(Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment)
- Assessment of withdrawal symptoms(Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment)
- Quality of life improvement(Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment)
- Compliance(Change from 1 month post-treatment at 3 months, 12 months and 24 months post-treatment)
- Self-confidence in benzodiazepines reduction(Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment)
- Global ACT processes improvement(Change from baseline at 1 month, 3 months, 12 months and 24 months post-treatment)