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

25 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

110

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Svezia
      • Uppsala, Svezia
        • Reclutamento
        • Uppsala University Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Arm 1

Treatment as Usual
Comportamentale: 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.
Sperimentale: Arm 2

Treatment as Usual + Group Therapy (EAET)
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Brief Mentalized Affectivity Scale (B-MAS)
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Life after Brain Injury (QOLIBRI)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Uppsala University

Collaboratori

Region Uppsala Public Health and Care

Investigatori

  • Cattedra di studio: Anna Nordström, M.D., Uppsala University
  • Cattedra di studio: Peter Nordström, Professor, Uppsala University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 settembre 2026

Completamento primario (Stimato)

1 giugno 2031

Completamento dello studio (Stimato)

1 giugno 2031

Date di iscrizione allo studio

Primo inviato

25 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 settembre 2026

Primo Inserito (Effettivo)

1 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • EAET after ABI

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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