Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

25. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

110

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Švédsko
      • Uppsala, Švédsko
        • Nábor
        • Uppsala University Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Arm 1

Treatment as Usual
Behaviorální: Treatment as Usual (TAU)

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.
Experimentální: Arm 2

Treatment as Usual + Group Therapy (EAET)
Behaviorální: TAU + 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Brief Mentalized Affectivity Scale (B-MAS)
Časové okno: 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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Quality of Life after Brain Injury (QOLIBRI)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Uppsala University

Spolupracovníci

Region Uppsala Public Health and Care

Vyšetřovatelé

  • Studijní židle: Anna Nordström, M.D., Uppsala University
  • Studijní židle: Peter Nordström, Professor, Uppsala University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. září 2026

Primární dokončení (Odhadovaný)

1. června 2031

Dokončení studie (Odhadovaný)

1. června 2031

Termíny zápisu do studia

První předloženo

25. září 2026

První předloženo, které splnilo kritéria kontroly kvality

25. září 2026

První zveřejněno (Aktuální)

1. října 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. října 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • EAET after ABI

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit