Intervention to Change Attributions That Are Negative (ICAN): a New Approach to Reducing Anger and Aggression After Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Buss-Perry Aggression Questionnaire Score
研究概览
简要总结
ICAN is the first treatment to target hostile attributions after TBI, making it a novel anger/ aggression management approach in this population. This is a randomized waitlist control trial. The length of time in the trial is approximately 15 weeks and the intervention is 6 weeks long.
详细描述
ICAN is the first treatment to target hostile attributions after TBI, making it a novel anger/ aggression management approach in this population. Since the investigator's prior research shows that stronger hostile attributions are associated with poorer perspective taking,39 ICAN employs a unique perspective-positioning technique to train perspective taking and reduce hostile attributions. After recalling a personal situation in which others' ambiguous actions led to an unpleasant outcome, participants will explore different perspectives: sitting or standing in one position, s/he will explore his or her own thoughts and feelings (self-perspective), then move to a different position to experience the other person's perspective, eliciting their thoughts and feelings.
In 40 participants with TBI, we will conduct a Phase I, randomized waitlist controlled trial with 4 data collection points: Baseline; Week 1; Week 8 (post-treatment for ICAN; post-wait period for WLC); Week 15 (WLC post-treatment).
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
- Triple (Participant, Care Provider, 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
- •History of complicated mild to severe TBI (injury due to an external physical force), with injury severity being defined either by Glasgow Coma Score at time of injury (≤12), or post-traumatic amnesia (≥1 day), or loss of consciousness (≥30 minutes), or positive head CT scan consistent with TBI.
- •At least 18 years of age or older;
- •≥1 year post-injury;
- •Have adequate vision, hearing, and speech/ language skills to participate in assessments and group therapy (determined based on interaction with the participant at screening)
- •Have adequate reading comprehension (due to the primary assessment involving written scenarios)
- •Have abnormal scores of negative attributions or perspective taking (determined at T0 screening)
- •Have above average aggression (prescreened on telephone, and confirmed T0 screening).
- •No anticipated medication changes for emotions/ behavior during length of study participation; medications for emotions/ behavior must be stable within last 30 days prior to consent at T0 (Screening)
- •Have reliable mode of transportation
排除标准
- •Pre-morbid neurological disorders that could affect mood and cognition (e.g. stroke); does not include controlled seizures
- •Progressive central nervous system disorders (e.g. dementia, Parkinson's)
- •Developmental disability (e.g., autism, developmental delay);
- •Major psychiatric disorders (e.g. schizophrenia, Borderline Personality Disorder);
- •Severe Depression and/or perceived risk to self or others (mental health resources will be provided and if suicide risk, approved suicide protocol will be utilized);
- •Currently receiving active behavioral therapy for anger.
- •On drug research study for irritability, anger, aggression
研究组 & 干预措施
ICAN
6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing
干预措施: ICAN (Behavioral)
WLC: Waitlist Control
WLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions.
干预措施: ICAN (Behavioral)
结局指标
主要结局
Change in Buss-Perry Aggression Questionnaire Score
时间窗: Change from Baseline at Week 8 and Week 15
The Buss-Perry Aggression Questionnaire (AQ), is a standardized measure comprised of 34 statements to assess total aggression, as well as the following aggression subconstructs: anger, hostile thoughts, and physical and verbal aggression. Participants rate statements using a 5-point Likert scale (1, 2, 3, 4, 5). Subscales are summed to compute a Total Aggression raw score and total Aggressions Scores were then converted to T scores (1-100) with a mean T-score =50 and Standard deviation=10 points. Higher T-scores= more aggression/ worse outcome, thus a lower number indicates improvement Here, we are reporting the CHANGE in the group's MEAN t-score (e.g. Mean Post-test T score of 62 MINUS Mean Pre-test t score of 58 = Mean CHANGE score of -4, which means less aggression post-treatment). Thus, we are NOT reporting t-scores in this Results section; just the mean change of these scores. Negative scores indicate an improvement.
次要结局
- Global Impression of Change for Anger and Aggression(Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after receiving treatment))
- Global Impression of Change for Perspective Taking and Empathy(Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after received treatment))
- Change in Anger Affect Score(Change from Week 1 at Week 8 and Week 15)
研究者
Dawn Neumann
Principal Investigator
Indiana University