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Group-based Emotional Awareness and Expression Therapy to Support Recovery After Acquired Brain Injury: A Clinical Development and Evaluation Study

2026年9月25日 更新者:Uppsala University

Difficulties in understanding and managing emotions may hinder recovery, rehabilitation, and participation in everyday life after acquired brain injury (ABI). Yet interventions targeting emotional adjustment after ABI remain limited.

The aim of the study is to investigate whether emotion-focused group therapy, based on Emotional Awareness and Expression Therapy (EAET), can support recovery after ABI. The intervention helps participants identify, process, and express emotions and needs related to their illness and changed life circumstances. Effects on emotional functioning, quality of life, activity, and participation will be assessed over time, alongside interviews exploring participants' experiences.

研究概览

详细说明

Surviving an acquired brain injury (ABI) often means having to learn to live with changes in abilities, roles, and relationships. For some, this adaptation itself becomes a barrier to continued recovery. Difficulties in understanding and managing emotions such as grief, fear and anger may affect how a person relates to their altered functional capacity, engages in rehabilitation, and resumes everyday activities and roles. Despite this, rehabilitation after ABI is primarily focused on physical and cognitive consequences, while targeted treatment options addressing emotional adjustment remain limited.

The aim of the study is to investigate whether emotion-focused group therapy can improve this aspect of recovery after ABI. The intervention is based on Emotional Awareness and Expression Therapy (EAET) and helps participants identify, process, and express emotions and needs that have emerged in response to the illness and changes in their life circumstances. The effects of the treatment on emotional functioning, quality of life, activity, and participation will be assessed over time and complemented by interviews exploring participants' experiences of the treatment and of life after stroke.

研究类型

介入性

注册 (估计的)

110

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Uppsala、瑞典
        • 招聘中
        • Uppsala University Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Person of working age, primarily 18-65 years.
  • Acquired brain injury.
  • At least three months since the time of injury.
  • Signs of significant psychological distress, such as mental health difficulties, vulnerability to mental health problems, or dysfunctional coping.
  • Sufficient cognitive functioning and proficiency in Swedish to participate in group-based talk therapy.

Exclusion Criteria:

  • Current severe mental illness (e.g., psychosis or severe personality disorder).
  • Active substance use disorder.
  • Severe cognitive impairment that precludes participation in group-based talk therapy.
  • Other medical conditions that, based on clinical assessment, may make participation inappropriate.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Arm 1

Treatment as Usual

Individually tailored multidisciplinary rehabilitation based on an assessment of each participant's rehabilitation needs. An individual rehabilitation plan is developed, and interventions are provided by relevant members of the rehabilitation team according to the participant's identified needs. Rehabilitation may include medical management, occupational therapy, physiotherapy, psychological treatment, and psychosocial support.

实验性的:Arm 2

Treatment as Usual + Group Therapy (EAET)

Behavioral: Treatment as usual • Individually tailored multidisciplinary rehabilitation based on an assessment of each participant's rehabilitation needs. An individual rehabilitation plan is developed, and interventions are provided by relevant members of the rehabilitation team according to the participant's identified needs. Rehabilitation may include medical management, occupational therapy, physiotherapy, psychological treatment, and psychosocial support.

Behavioral: Group-based Emotional and Expression Therapy (EAET)

• 10-session manualized group-based Emotional Awareness and Expression Therapy (EAET) designed to help participants identify, process, and express emotions and needs. Weekly group sessions are complemented by structured homework assignments. A follow-up session is provided three months after completion of the intervention. The intervention is delivered by a clinical psychologist.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Brief Mentalized Affectivity Scale (B-MAS)
大体时间:Baseline (pre-intervention), post-treatment (10 weeks after baseline), 3-month follow-up (approximately 22 weeks after baseline), 12-month follow-up (approximately 62 weeks after baseline).

Evalutates three core components of emotion regulation: "Identifying emotions"; "Processing emotions", "Expressing emotions".

Baseline (pre-intervention), post-treatment (10 weeks after baseline), 3-month follow-up (approximately 22 weeks after baseline), 12-month follow-up (approximately 62 weeks after baseline).

次要结果测量

结果测量
措施说明
大体时间
Quality of Life after Brain Injury (QOLIBRI)
大体时间:Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

QOLIBRI consists of 37 items in six scales. Health-related quality of life is assessed in the areas of "Cognition," "Self," "Daily Life and Autonomy," and "Social Relationships," and feeling bothered by "Emotions," and "Physical Problems."

Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)
大体时间:Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

Six item scale that ask about health related quality of life in six dimensions: "Physical condition, "Cognition", "Emotions", "Ability to carry out daily activities", "Personal and social life" and "Current situation and future prospects"

Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Short Form 36 (SF-36)
大体时间:Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH).

Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
大体时间:Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

Score of 0-64, with a higher score indicates worse symptoms.

Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Insomnia Severity Index (ISI)
大体时间:Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

Score of 0-28, where higher scores indicate severity of insomnia.

Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
大体时间:Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

Score of 0-15, where higher scores indicate severity of anxiety experienced.

Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Patient Health Questionnaire-9 (PHQ-9)
大体时间:Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

Score of 0-27, where higher scores indicate severity of depression experienced.

Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Patient Health Questionnaire-15 (PHQ-15)
大体时间:Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

Score of 0-30, where higher scores indicate severity and burden of common physical symptoms.

Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Fear Avoidance Behavior after Traumatic Brain Injury Questionnaire (FAB-TBI)
大体时间:Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

Score of 0-48, where higher score indicates higher avoidance.

Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Behavioral Responses to Illness Questionnaire (BRIQ)
大体时间:Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

Evalutates behavioral response to illness on a four factor subscale: "All-or-Nothing Behavior", "Limiting Behavior", "Emotional Support Seeking" and "Practical Support Seeking".

Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Alcohol Use Disorders Identification Test (AUDIT)
大体时间:Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

Score of 0-40, where higher score indicates greater risk of problematic alcohol use.

Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Drug Use Disorders Identification Test (DUDIT)
大体时间:Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

Score of 0-44, where higher score indicates greater risk of problematic drug use.

Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Anna Nordström, M.D.、Uppsala University
  • 学习椅:Peter Nordström, Professor、Uppsala University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月15日

初级完成 (估计的)

2031年6月1日

研究完成 (估计的)

2031年6月1日

研究注册日期

首次提交

2026年9月25日

首先提交符合 QC 标准的

2026年9月25日

首次发布 (实际的)

2026年10月1日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年9月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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