Group-based Emotional Awareness and Expression Therapy to Support Recovery After Acquired Brain Injury: A Clinical Development and Evaluation Study
1 other identifier
interventional
110
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2026
CompletedFirst Submitted
Initial submission to the registry
September 25, 2026
CompletedFirst Posted
Study publicly available on registry
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
October 1, 2026
September 1, 2026
4.7 years
September 25, 2026
September 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brief Mentalized Affectivity Scale (B-MAS)
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).
Secondary Outcomes (12)
Quality of Life after Brain Injury (QOLIBRI)
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)
Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Short Form 36 (SF-36)
Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Insomnia Severity Index (ISI)
Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
- +7 more secondary outcomes
Study Arms (2)
Arm 1
ACTIVE COMPARATORTreatment as Usual
Arm 2
EXPERIMENTALTreatment as Usual + Group Therapy (EAET)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Region Uppsala Public Health and Carecollaborator
Study Sites (1)
Uppsala University Hospital
Uppsala, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anna Nordström, M.D.
Uppsala University
- STUDY CHAIR
Peter Nordström, Professor
Uppsala University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2026
First Posted
October 1, 2026
Study Start
September 15, 2026
Primary Completion (Estimated)
June 1, 2031
Study Completion (Estimated)
June 1, 2031
Last Updated
October 1, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share