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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. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

110

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Sverige
      • Uppsala, Sverige
        • Rekruttering
        • Uppsala University Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Arm 1

Treatment as Usual
Atferdsmessig: 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.
Eksperimentell: Arm 2

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Brief Mentalized Affectivity Scale (B-MAS)
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of Life after Brain Injury (QOLIBRI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Uppsala University

Samarbeidspartnere

Region Uppsala Public Health and Care

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. september 2026

Primær fullføring (Antatt)

1. juni 2031

Studiet fullført (Antatt)

1. juni 2031

Datoer for studieregistrering

Først innsendt

25. september 2026

Først innsendt som oppfylte QC-kriteriene

25. september 2026

Først lagt ut (Faktiske)

1. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EAET after ABI

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