Neurobehavioral Affective Control Training (N-ACT): A Randomized Waitlist-controlled Pilot Trial to Evaluate a Novel Cognitive Remediation Program for Emotion-related Impulsivity and Rumination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Emotion-related impulsivity (ERI)
研究概览
简要总结
The goal of this clinical trial is to test a new cognitive training program to improve emotion regulation in adults. The investigators' primary aim is to determine whether participating in this program addresses two key features of emotion dysregulation associated with psychiatric disorders: (1) emotion-related impulsivity and (2) rumination. The investigators will further evaluate participants' perceived acceptability and feasibility of treatment procedures. Secondarily, the investigators will examine the effects of this cognitive training intervention on psychiatric symptoms and overall functioning. The researchers will compare the cognitive training program to a waitlist control.
Participants will be asked to complete eight weekly sessions (over two months) involving cognitive training exercises with a "coach", in addition to a baseline assessment before starting the intervention and post-treatment assessment. Each assessment includes a combination of in-person and remote data collection using self-report questionnaires, psychophysiology, and a neuropsychological battery. Participants will also complete one week of ecological momentary assessment before and after the intervention as well as a set of follow-up questionnaires administered remotely six weeks following their final training session. Researchers will compare participants randomly assigned to complete the intervention without delay to a control group of participants randomly assigned to a two-month waitlist before joining the intervention. Before beginning cognitive training, participants in the control condition will complete an additional pre-intervention/post-waitlist assessment, which will follow parallel procedures to the initial baseline assessment.
详细描述
This randomized waitlist-controlled pilot trial will enroll adult participants who self-report high levels of rumination and/or emotion-related impulsivity. The primary aim of this study is to examine the acceptability, efficacy, and feasibility of Neurobehavioral Affective Control Training (N-ACT) as a novel therapeutic approach to reduce emotion-related impulsivity and rumination in adults by improving two types of affective inhibitory control: (1) emotional response inhibition and (2) emotional working memory. Secondarily, study investigators will test anticipated transfer effects of N-ACT on other behavioral indices of cognitive control (beyond emotional response inhibition and emotional working memory) and other subjective measures of emotion dysregulation (beyond trait emotion-related impulsivity and rumination), as well as on psychopathology symptom severity and functional impairment. In addition to performing intent-to-treat analyses, the investigators will conduct analyses to evaluate the extent to which program adherence predicts hypothesized intervention effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current residency in the state of California
- •Elevated levels of rumination and/or emotion-related impulsivity
排除标准
- •Insufficient English language literacy to understand study procedures (as assessed by self-report)
- •Careless or inattentive responding as indicated by (a) failing 50% or more of "attention check" items embedded in the online screening questionnaires, (b) overly rapid responding (i.e., mean response time of less than two seconds for multiple choice items), or (c) qualitative review of long strings of identical entries on screening/baseline questionnaire items that suggest data invalidity
- •Positive history of brain tumors, neurological disorders, or head injuries (with loss of consciousness more than five minutes and/or more than two separate instances of clinically-significant head trauma)
- •Recent (i.e., past three months) alcohol/other substance use disorders or current psychosis (as assessed by the Mini International Neuropsychiatric Interview; MINI)
- •Active suicidal ideation paired with either (1) plan and/or intent or (2) lifetime history of suicide attempts (as assessed by the Columbia Suicide Severity Rating Scale; C-SSRS)
研究组 & 干预措施
N-ACT without delay
After a baseline in-person assessment session (Week 1), participants randomly assigned to the experimental condition (i.e., "N-ACT without delay") will complete one week of pre-intervention ecological momentary assessment (EMA; Week 2), then the intervention (Weeks 3-10), followed by a post-treatment in-person assessment session with comparable measures to baseline (Week 11) and a second week of (post-intervention) EMA (Week 12).
干预措施: Neurobehavioral Affective Control Training (Behavioral)
Waitlist control
Participants randomly assigned to the two-month waitlist control condition will be recontacted approximately 10 weeks after the baseline in-person assessment session (Week 1) to complete a second assessment session (with comparable measures) post-waitlist, prior to starting the N-ACT program. The post-waitlist assessment session (Week 11) after the waitlist period (Weeks 2-10) will precede a series of procedures equivalent to the experimental ("N-ACT without delay") arm: One subsequent week of pre-intervention (post-waitlist) ecological momentary assessment (EMA; Week 12), then eight weeks of N-ACT (Weeks 13-20), followed by a third and final in-person (post-intervention) assessment (Week 21) with parallel procedures to the baseline and post-waitlist sessions, as well as a second week of EMA (Week 22). All study procedures are identical between the two trial arms, with the exception of an added eight-week waitlist and post-waitlist assessment for participants in the control condition.
干预措施: Neurobehavioral Affective Control Training (Behavioral)
结局指标
主要结局
Emotion-related impulsivity (ERI)
时间窗: (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)
ERI will be measured using the self-rated Three-Factor Impulsivity Index "Feelings Trigger Action" scale using standard scoring methods (range: 1-5; larger values indicate higher levels of this characteristic). The researchers will perform a 2 (Arm/Condition: Experimental vs. Control) X 2 (Time: T1 vs. T2) Multivariate Analysis of Covariance (MANCOVA) to evaluate if N-ACT completion is associated with greater pre/post reductions in ERI scores compared to waitlist, as predicted.
Rumination
时间窗: (T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11)
Rumination will be measured using the self-rated "Brooding" subscale of the Ruminative Responses Scale using standard scoring methods (range: 5-20; larger values indicate higher levels of this characteristic). The researchers will perform a 2 (Arm/Condition: Experimental vs. Control) X 2 (Time: T1 vs. T2) MANCOVA to evaluate if N-ACT completion is associated with greater pre/post reductions in Rumination scores compared to waitlist, as predicted.
次要结局
- Emotional Working Memory((T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11))
- Cold Response Inhibition((T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11))
- Emotional Response Inhibition((T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11))
- Affective Flexibility((T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11))
- Externalizing factor score((T1) Baseline (Week 1); (T2) Post-intervention (Week 11 or Week 21 for control arm))
- Cold Working Memory((T1) Baseline (Week 1); (T2) Post-waitlist or post-intervention (Week 11))
- Internalizing factor score((T1) Baseline (Week 1); (T2) Post-intervention (Week 11 or Week 21 for control arm))