Randomized Clinical Trial With Adapted Skill Training Group From Dialectical Behavior Therapy as add-on Treatment for Adults With Attention Deficit/Hyperactive Using Medication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Adult Attention-Deficit/Hyperactive Disorder Self Rating Scale
研究概览
简要总结
Attention-Deficit/Hyperactive Disorder (ADHD) in adults is associated with global impairments and deficits in quality of life. The ADHD functional impairments during adulthood usually persist even after adequate medication treatment. The Skill Training Group of the Dialectical Behavioral Therapy (DBT) is one of the group therapies that had been adapted for the specific treatment of ADHD patients. Our primary aim is to explore the feasibility of the approach in different culture and to evaluate the efficacy of the Skill Training Group as an add-on treatment for adults using ADHD medication. This is a Randomized Clinical Trial comparing the Skill Training Group added to stimulants to treatment as usual. 52 adults previously diagnosed with ADHD and treated with stimulants in our ADHD outpatient program will be enrolled. Only patients with residual symptoms will be included (ADHD-Self Report Scale - ASRS ≥ 20). The intervention comprises the standard 12 sessions therapy program. The groups will have between 8 and 12 patients each, and will be conducted by a trained DBT therapist with supervision from a senior DBT therapist. The primary outcome will be the ASRS scores. Secondary outcomes include scores in ADHD Quality of Life, Beck's Depression Inventory, Beck's Anxiety Inventory, and performance in a neuropsychological test (difference between pre and post-intervention) (Stop Signal Task). Adherence to the protocol will also be checked. The recruitment was initially scheduled for beginning in November.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ADHD
- •Medicated with following drugs and minimum daily dosages:
- •Methylphenidate ≥ 0.5 mg/kg Lisdexamfetamine ≥ 30mg Bupropion ≥ 150 mg Modafinil ≥ 200mg Imipramine ≥ 1mg/kg
- •At least one month of stabilized dosage for any psychiatric medication.
- •ADHD-Self Report Scale ≥
- •Knowledge of oral and written communication in Portuguese
- •IQ>85 (intelligence quotient)
排除标准
- •diagnoses of Borderline or Anti-social personality disorders.
- •diagnoses of autism spectrum disorder
- •current episode of major depression or suicide toughs
- •current episodes of mania or hypomania
- •recent episodes of drug abuse (last 6 months)
- •diagnoses of drug dependence
- •patients that change their medications or their psychiatric conditions in the exclusion criteria above after the beginning of the protocol will have their data censored, but included in the intention to treat analyses. These patients will keep the right to attend all the sessions in the protocol at their discretion.
结局指标
主要结局
Change in Adult Attention-Deficit/Hyperactive Disorder Self Rating Scale
时间窗: 12 Weeks
Sefl rated scale to measure Attention Deficit Hyperactive Disorder Symptoms Symptoms. ASRS has 18 questions about ADHD symptoms. Each question is scored between 0 (never happen), and 4 (very frequently). The total score goes from 0 up to 72. Higher scores mean more symptoms and higher ADHD's impairments.
次要结局
- Change in Attention-Deficit/Hyperactive Disorder Quality of Life - Mid-treatment(6 weeks)
- Change in Beck Depression Inventory(12 Weeks)
- Change in Beck Depression Inventory - Mid-treatment(6 Weeks)
- Change in Attention-Deficit/Hyperactive Disorder Self Rating Scale - Mid-treatment(6 Weeks)
- Change in Attention-Deficit/Hyperactive Disorder Quality of Life(12 Weeks)
- Change in Beck Anxiety Inventory(12 Weeks)
- Change in Beck Anxiety Inventory - Mid-treatment(6 Weeks)
- Change in the reflexive function questionnaire - Mid-treatment(6 weeks)
- Change in Stroop Task(14 Weeks)
- Change in the reflexive function questionnaire(12 weeks)
- Change in the Go NoGo(14 weeks)