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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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

110

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Uppsala、スウェーデン
        • 募集
        • Uppsala University Hospital
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.

実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Brief Mentalized Affectivity Scale (B-MAS)
時間枠: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).

二次結果の測定

結果測定
メジャーの説明
時間枠
Quality of Life after Brain Injury (QOLIBRI)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディチェア:Anna Nordström, M.D.、Uppsala University
  • スタディチェア:Peter Nordström, Professor、Uppsala University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年9月15日

一次修了 (推定)

2031年6月1日

研究の完了 (推定)

2031年6月1日

試験登録日

最初に提出

2026年9月25日

QC基準を満たした最初の提出物

2026年9月25日

最初の投稿 (実際)

2026年10月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月1日

QC基準を満たした最後の更新が送信されました

2026年9月25日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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