Efficacy Evaluation of Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorder

跨诊断 CBT 对共病酒精使用和焦虑症的疗效评估

• 批准号: 9263535
• 负责人: David H. Barlow
• 金额: $ 42.96万
• 依托单位: BOSTON UNIVERSITY (CHARLES RIVER CAMPUS)
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-05 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9263535
• 关键词: Address; Adult; Aftercare; Alcohol consumption; Alcohol dependence; Alcoholic beverage heavy drinker; Alcohols; Anterior; Anticonvulsants; Anxiety; Anxiety Disorders; Back; Behavior Therapy; Benchmarking; Biological Markers; Blood; Blood specimen; Brain; Chronic; Clinical; Clinical Trials; Cognitive Therapy; Collaborations; Comorbidity; Complement; Conduct Clinical Trials; Control Groups; DSM-V; Development; Diagnosis; Diagnostic; Disease; Double-Blind Method; Ecological momentary assessment; Emotional disorder; Glutamates; Glutathione; Goals; Health Care Costs; Heavy Drinking; Individual; Intervention; Interview; Lead; Magnetic Resonance Spectroscopy; Maintenance; Measures; Mediating; Mental Depression; Mood Disorders; National Institute on Alcohol Abuse and Alcoholism; Neurobiology; Neurotic Disorders; Neurotics; Obsessive compulsive behavior; Outcome; Outcome Measure; Oxidative Stress; Participant; Patients; Pharmaceutical Preparations; Placebo Control; Placebos; Procedures; Productivity; Property; Protocols documentation; Protons; Psychotherapy; Public Health; Questionnaires; Randomized; Randomized Clinical Trials; Reporting; Research; Resistance; Risk; Sample Size; Schedule; Severities; Stress; Symptoms; Temperament; Testing; TimeLine; Treatment outcome; Work; active method; acute symptom; alcohol abuse therapy; alcohol comorbidity; alcohol craving; alcohol use disorder; anxiety reduction; anxiety treatment; cingulate cortex; comparative; compare effectiveness; craving; drinking; early alcohol use; early onset; economic cost; effective therapy; efficacy evaluation; emotion dysregulation; emotion regulation; emotional distress; follow-up; gamma-Aminobutyric Acid; group intervention; innovation; mortality; neurochemistry; novel; pill; primary outcome; psychologic; reduce symptoms; screening; treatment duration; treatment effect; treatment group; treatment response; venlafaxine

PROJECT SUMMARY/ABSTRACT Anxiety disorders (AXD) occur in up to one-third of individuals with alcohol dependence seeking treatment and are associated with poor treatment response in people who have comorbid alcohol use disorders (AUD). Despite the major personal and public health impact of this comorbidity, effective treatments have not been established and there is a lack of adequate research to guide treatment decisions. In recent work we have demonstrated that the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow, Farchione, et al., 2011) significantly reduced heavy drinking in comorbid AUD/AXD disorders, but venlafaxine, a drug approved by the US FDA for treatment of anxiety, did not have an effect on drinking, despite decreasing anxiety and depression. In clinical trials that we conducted zonisamide (ZON) administration reduced alcohol consumption in individuals with AUD, as reflected by decreased percent days with heavy drinking; decreased drinks consumed per day, and decreased percent days with any drinking. The current proposal will examine an established transdiagnostic cognitive-behavioral intervention for emotional disorders (e.g., anxiety and mood disorders), the UP, relative to ZON, a medication that directly influences alcohol consumption without working through the mechanism of anxiety reduction. The central focus of this proposal is to examine the efficacy of UP and ZON in reducing alcohol consumption in patients with comorbid AUD/AXD, relative to a low intensity behavioral treatment control consisting of Take Control (TC), a novel form of psychotherapy for AUD that we developed in collaboration with the NIAAA, in combination with pill placebo (PLC). We propose a placebo- controlled, double-blind clinical trial with three groups: 1) UP, 2) ZON, and 3) TC+PLC. After screening, all participants will receive treatment for 16 weeks. ZON will be reduced during study weeks 17 and 18, following a post-treatment assessment, and follow-up measures will be obtained one month and six months after the post-treatment assessment. Alcohol consumption will be assessed using both ecological momentary assessment and the time-line follow back procedures. The Depression Anxiety Stress Scale, Hamilton Anxiety and Depression Rating scales, and the Anxiety Disorders Interview Schedule for DSM-5 will be used to measure anxiety and depression. Complementing these assessments are additional scales examining higher- order temperamental variables and core psychopathological mechanisms related to emotional dysregulation that have been shown to contribute to the development and maintenance of these disorders and may account for the high amount of diagnostic overlap seen clinically. Further, we will use magnetic resonance spectroscopy (MRS) to examine the effects of UP and ZON on changes in brain glutamate (Glu), GSH, and GABA levels, and analyze blood samples to measure GSH and other oxidative stress biomarkers. Using MRS to measure changes in these neurochemicals during treatment may lead to a better mechanistic understanding of UP and ZON, and possibly help optimize use of these treatments in patients with AUD.

项目概要/摘要 多达三分之一的寻求治疗和治疗的酒精依赖者患有焦虑症 (AXD) 与患有共病酒精使用障碍 (AUD) 的人的治疗反应不佳有关。 尽管这种合并症对个人和公共健康产生了重大影响，但尚未找到有效的治疗方法 已建立，但缺乏足够的研究来指导治疗决策。在最近的工作中我们有 证明情绪障碍跨诊断治疗统一方案（UP；Barlow， Farchione 等人，2011）显着减少了合并 AUD/AXD 疾病的大量饮酒，但文拉法辛， 美国 FDA 批准的一种治疗焦虑症的药物，尽管减少了饮酒，但对饮酒没有影响 焦虑和抑郁。在我们进行的唑尼沙胺（ZON）给药减少酒精的临床试验中 澳元个人的消费量，如酗酒天数百分比下降所反映；减少 每天饮用的饮料，以及饮酒天数减少的百分比。目前的提案将审​​查 建立了针对情绪障碍（例如焦虑和情绪障碍）的跨诊断认知行为干预 疾病），UP，相对于 ZON，一种直接影响饮酒但不起作用的药物 通过减少焦虑的机制。该提案的核心重点是检验 UP 的功效 相对于低强度，ZON 可以减少合并 AUD/AXD 患者的饮酒量 行为治疗控制包括 Take Control (TC)，这是一种针对 AUD 的新型心理治疗形式，我们 与 NIAAA 合作开发，与药丸安慰剂 (PLC) 相结合。我们建议使用安慰剂—— 对照、双盲临床试验，分为三组：1) UP、2) ZON 和 3) TC+PLC。经过筛选后，全部 参与者将接受为期16周的治疗。 ZON 将在研究第 17 周和第 18 周期间减少，如下 治疗后评估，并在治疗后1个月和6个月获得后续措施 治疗后评估。酒精消耗量将使用生态瞬时 评估和时间表遵循回溯程序。抑郁焦虑压力量表，汉密尔顿焦虑 和抑郁评定量表，以及 DSM-5 的焦虑症访谈时间表将用于 测量焦虑和抑郁。对这些评估的补充是检查更高级别的额外量表 与情绪失调相关的气质变量和核心心理病理机制 已被证明有助于这些疾病的发展和维持，并可能解释 临床上发现大量的诊断重叠。此外，我们将使用磁共振 光谱 (MRS) 检查 UP 和 ZON 对大脑谷氨酸 (Glu)、GSH 和 GABA 水平，并分析血液样本以测量 GSH 和其他氧化应激生物标志物。使用MRS 测量治疗期间这些神经化学物质的变化可能会带来更好的机制理解 UP 和 ZON 的研究，可能有助于优化 AUD 患者的这些治疗方法。