Bridging the Gap in the Study of Bipolar Disorder and Attention Deficit Hyperactivity Disorder: Impact of cognitiVE Reserve and funCtioning in a Newly Designed Treatment intervenTion for comORbidity (VECTOR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Functioning Assessment Short Test (FAST)
研究概览
简要总结
Cognitive dysfunctions are present in Bipolar Disorder (BD) and Attention Deficit Hyperactivity Disorder (ADHD) and may negatively impact psychosocial functioning. Further, comorbid BD and ADHD (BD-ADHD) is prevalent, associated with an earlier BD onset and a less favorable prognosis. Nevertheless, there is a paucity of research dedicated to the characterization and treatment of comorbid BD-ADHD.
This study aims to develop and evaluate the effectiveness of a novel psychological group intervention (VECTOR) for adults with BD-ADHD. VECTOR integrates elements from Cognitive Behavioral Therapy (CBT) for ADHD and Functional Remediation (FR) for BD.
Eighty patients will be randomized (1:1) to receive either the VECTOR program (12 weekly group sessions) or treatment as usual (TAU).
It is expected that the VECTOR program will result in greater improvements in functioning and symptom reduction compared to TAU.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill DSM-5 criteria for BDI or BDII and ADHD using the Structured Clinical Interview for DSM-5 and the Conners' Adult ADHD Diagnostic Interview (CAARS)
- •Stable pharmacological treatment for at least the past three months.
- •Being in full or partial remission Young Mania Rating Scale (YMRS) ≤ 10, Hamilton Depression Rating Scale (HDRS) ≤ 14) at the time of the inclusion and assessment
- •ADHD rating scale≥24
排除标准
- •Any comorbid psychiatric condition
- •Diagnosis of substance abuse disorder in the past 12 months
- •Intellectual disability (intelligence quotient < 70)
- •Having any Central Nervous System illness, independent of primary psychiatric diagnosis, hampering neuropsychological performance
- •Participation in a structured psychological intervention during the study period.
结局指标
主要结局
Functioning Assessment Short Test (FAST)
时间窗: Baseline, post-treatment (12 weeks) and 12 months
24-item scale assessing disability in six functional domains: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time. Assessed by a blind expert rater.
Clinical Global Impression - Severity (CGI-S)
时间窗: Baseline, post-treatment (12 weeks) and 12 months
Severity scale measuring global symptom severity. Assessed by a blind expert rater.
次要结局
- Change in the severity of ADHD symptoms(Baseline, post-treatment (12 weeks) and 12 months)
- Change in the ADHD-Rating Scale (ADHD-RS)(Baseline, post-treatment (12 weeks) and 12 months)
- Change in the Hamilton Depression(Baseline, post-treatment (12 weeks) and 12 months)
- Change in the Young Mania Rating Scale (YMRS)(Baseline, post-treatment (12 weeks) and 12 months)
- Change in attention - Trail Making Test Part A (TMT-A)(Baseline, post-treatment (12 weeks) and 12 months)
- Change in cognitive flexibility - Trail Making Test Part B (TMT-B)(Baseline, post-treatment (12 weeks) and 12 months)
- Change in sustained attention - Conners' Continuous Performance Test (CPT)(Baseline, post-treatment (12 weeks) and 12 months)
- Change in executive function - Wisconsin Card Sorting Test (WCST)(Baseline, post-treatment (12 weeks) and 12 months)
- Change in inhibitory control - Stroop Test(Baseline, post-treatment (12 weeks) and 12 months)
- Change in verbal fluency - Phonemic and Semantic Fluency (PMR)(Baseline, post-treatment (12 weeks) and 12 months)