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临床试验/NCT06697587
NCT06697587已完成不适用

Enhanced Cognitive Reappraisal and Emotion Awareness Training (eCREAT) for Maladaptive Anger Inhibition - A Pilot Study

Örebro University, Sweden1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
State-Trait Anger Expression Inventory-2, Anger-Expression In scale (STAXI-2; AX-I)

研究概览

简要总结

Habitual suppression of intense anger, commonly known as maladaptive anger inhibition, is a widespread issue related to various adverse outcomes. These include, for instance, diminished social support, reduced relationship quality, increased risk for coronary heart disease, and heightened susceptibility to chronic and temporary pain conditions. Developing effective psychological treatments may be one key approach to alleviate the distress experienced amongst these individuals.

The overall goal of this pilot study is to further develop and enhance a previously evaluated treatment protocol for maladaptive anger (Bjureberg et al., 2023) to more effectively target maladaptive anger inhibition. The specific goals are:

  1. To assess the feasibility and acceptability of the study (operationalized as number of completed modules and measurements, reported negative events and patient experience).
  2. To assess outcome variability and estimate the relative effect of the treatment in reducing maladaptive anger inhibition. Maladaptive anger inhibition was operationalized as high levels of trait anger suppression (main outcome), anger rumination (secondary outcome) as well as low levels assertive expression of anger (secondary outcome).

Secondary aims (to be reported in secondary papers) 3. To assess and explore participants' qualitative experiences of maladaptive anger inhibition. 4. To explore within-subjects emotion dynamics using daily assessments.

详细描述

  1. Treatment feasibility and acceptability will be assessed by measuring treatment retention and adherence (operationalized as number of drop-outs, completed modules, homework assignments, and assessments), treatment credibility and satisfaction (using questionnaires), number of reported adverse events and patient experiences following treatment (see below for details).
  2. Following the intention to treat principle data will be analyzed using all participants that were included in the treatment. Preliminary treatment efficacy will be determined by assessing the phase effect of the treatment for each respective outcome (trait anger suppression, anger rumination, and anger assertiveness). More specifically, an interrupted time series design will be used to compare the difference in effect between the treatment phase and a prolonged baseline phase, each consisting of 4 assessments (totaling 8 measurement points). The primary phase effects will be evaluated at treatment termination. Moreover, we will also explore whether treatment effects are maintained at the 3-month follow-up.
  3. A subset of 10 consenting participants will be invited to post-treatment interviews. Participants will chosen so as to ensure representation across demographic and clinical variables such as age, gender, and whether they improved or not on the main outcome (trait anger suppression). Interviews will both focus on treatment experiences (goal 1) and participants' qualitative experiences of maladaptive anger inhibition (goal 3).
  4. Participants will complete two bursts of 7 days of daily measures of anger and anger regulation strategies, one burst before treatment and one after). These daily measurements will be used to explore within-subject emotion dynamics by comparing emotion dynamics before and after the treatment using dynamic structural equation modeling (DSEM) as our analytical method.

Assessment procedure:

Participants will undergo intensive assessment throughout the project. Participants will complete 1 screening assessment followed by 4 weeks of weekly baseline assessments, with one of the weeks including daily assessments (burst 1). Following the baseline phase, participants will enroll in a 4-week online treatment with weekly assessments. After treatment, participants will undergo 1 week of daily assessments (burst 2) and a 3-month follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Experience of maladaptive anger inhibition as indicated by a score on the upper quartile on the Anger Expression-In scale from State-Trait Anger Expression Inventory-2 (STAXI-2).

排除标准

  • Risk for violence and harm to others.
  • Prior convictions of violence/abuse.
  • Ongoing psychological treatment.
  • Change in psychotropic medication within 2 months prior to enrollment.
  • Severe psychiatric disorder, such as severe depression or psychotic disorder
  • Ongoing substance use.
  • Life circumstances that interfere with treatment.
  • Suicidal ideation.
  • Not able to read and write in Swedish or learning difficulties (the treatment-format requires normal literacy skills).

结局指标

主要结局

State-Trait Anger Expression Inventory-2, Anger-Expression In scale (STAXI-2; AX-I)

时间窗: Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.

Used to assess symptom severity of maladaptive anger inhibition. The AX-I scale has 8 items, each rated on a 4 point, with higher scores reflecting higher degree of anger inhibition. Self-rated.

次要结局

  • Behavioral Anger Response Questionnaire, Assertion scale (BARQ; assertion)(Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.)
  • Anger Rumination Scale (ARS)(Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.)
  • Self-Critical Rumination Scale (SCRS)(Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.)
  • Thought Suppression Inventory - Revised, Suppression attempts scale (TSI; Suppression attempts)(Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.)
  • Emotion Regulation Questionnaire (ERQ)(Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up.)
  • Five Facets Mindfulness Questionnaire (FFMQ)(Screening, 4 weeks baseline (weekly), 4 weeks treatment (weekly), and 3-month follow-up (see description for details).)
  • Aggression Questionnaire (AQ)(Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.)
  • Indirect Aggression Scale for perpetrators (IAS-A)(Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.)
  • Perth Alexithymia Questionnaire-Short Form (PAQ-S)(Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.)
  • Difficulties with Emotion Regulation Scale-16 (DERS-16)(Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up)
  • Symptom Scale-8 (SSS-8)(Screening, treatment week 4 (post), and at the 3-month follow-up.)
  • Affective Control Scale, fear of anger subscale (ACS)(Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.)
  • State-Trait Anger Expression Inventory-2, Anger-Expression Out scale, and trait anger (STAXI-2; AX-O;T-ANG)(Screening, baseline week 4 (pre), treatment week 4 (post), and at the 3-month follow-up.)

研究者

发起方
Örebro University, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hugo Hesser

Professor Hugo Hesser

Örebro University, Sweden

研究点 (1)

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