NCT03858296已完成不适用
Randomized Controlled Trial of Emotion Regulation for Inappropriate Anger Expression
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- State-Trait Anger Expression Inventory-2 (Subscales: Anger-out, Anger-in)
研究概览
简要总结
The overall aim of the project is to develop three internet-delivered cognitive behavior therapies for inappropriate anger expression to test the isolated and combined effects of two types of regulation strategies, emotional awareness and cognitive reappraisal. Treatments will be evaluated in a stratified single blind parallel randomized block design, along with a pooled interrupted time series design. Self-recruited adults with elevated levels of anger will be stratified based on baseline level of anger. The particular aims are to examine:
- the overall and separate effects of emotional awareness training, cognitive reappraisal training, and emotional awareness and cognitive reappraisal training on anger and aggression;
- whether treatment effects are differentially moderated by baseline levels of emotional awareness, cognitive reappraisal, anger expression-out, anger expression-out, anger control-in, and trait anger;
- whether the treatment effects are mediated by changes in emotional awareness, cognitive reappraisal, and anger control-in.
详细描述
- Following the intention-to-treat principle, all primary data models will include all individuals as randomized. 3-month follow-up will be considered as the primary end-point. We will analyze both (1) overall treatment effect of all treatments (active treatment phase and 3-month follow-up compared to baseline) and (2) the relative efficacy for the emotional awareness training, cognitive reappraisal training, and emotional awareness and cognitive reappraisal training, respectively. We expect that, compared to a prolonged baseline phase, all treatments will result in greater improvements in on both primary and secondary outcomes. Further, we predict that the combined intervention will produce, on average, the strongest effects on primary and secondary outcomes relative to the separate interventions. We expect that cognitive reappraisal training will result in greater improvements relative to emotional awareness as a standalone treatment.
- Growth models that include the interaction terms between experimental conditions (contrast coded) and baseline levels of moderator variables (as continuous measures) will be utilized to examine moderated treatment effects. Significant interactions will be examined following recommendations for probing interactions in growth models.
- Weekly measurements of mediators will be analyzed with state-of-the-art methods for longitudinal mediation analysis, and we aim to to examine associations among process and outcome variables both within and between individuals as a function of condition and treatment phase.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •experience of inappropriate anger expression that leads to significant distress or interferes with daily life (based on the STAXI-II)
排除标准
- •risk for violent behavior that may harm others
- •prior convictions of violence/abuse
- •ongoing psychological treatment that may conflict with the offered treatment
- •change in psychotropic medication within 2 months prior to enrollment
- •severe psychiatric disorder, such as severe depression or risk of suicide
- •alcohol or drug problems
- •life circumstances that interfere with treatment (e.g., homeless)
- •pronounced language skill deficits and learning difficulties (as the treatment format assumes normal reading and writing skills)
研究组 & 干预措施
Emotional awareness
Experimental
4 modules of emotional awareness training
干预措施: Internet-delivered emotional awareness training (Behavioral)
Cognitive reappraisal
Experimental
4 modules cognitive reappraisal training
干预措施: Internet-delivered Cognitive reappraisal training (Behavioral)
Awareness + reappraisal
Experimental
4 modules emotional awareness and cognitive reappraisal training
干预措施: Internet-delivered awareness and reappraisal training (Behavioral)
结局指标
主要结局
State-Trait Anger Expression Inventory-2 (Subscales: Anger-out, Anger-in)
时间窗: Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended.
Levels of State-trait anger Expression. The subscales Anger Expression-Out (range: 8-32), Anger Expression-In (range: 8-32), and State Anger (range: 15-60) will be used, with higher scores indicating more anger.
次要结局
- Emotion Regulation Questionnaire (Subscale: Reappraisal)(Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended.)
- Five Facets Mindfulness Questionnaire (Subscales: Nonreactivity, Non-judging)(Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended.)
- State-Trait Anger Expression Inventory-2 (Subscale: Anger control-in)(Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended.)
- State-Trait Anger Expression Inventory-2 (Subscales: Trait anger, Anger control-out, State anger)(Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended)
- Aggression Questionnaire(Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended. Ranges from 0-87, with higher higher scores indicating more aggression problems.)
- Anger Rumination Scale(Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended)
- Five Facets Mindfulness Questionnaire(Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended)
- Emotion Regulation Questionnaire (Subscale Suppression)(Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended.)
- The Pittsburgh Sleep Quality Index(Change from baseline, 4 weeks after treatment starts, and 3 months after treatment has ended)
- Perceived Stress Scale 10 item version(Change from baseline, once every week during treatment (0-4 weeks after baseline), and 3 months after treatment has ended.)
研究者
Johan Bjureberg
Licenced Psychologist, PhD
Karolinska Institutet
研究点 (1)
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