Aquired Brain InjuryNCT07852936
Group-based Emotional Awareness and Expression Therapy to Support Recovery After Acquired Brain Injury: A Clinical Development and Evaluation Study
A study testing TAU + Group Therapy (EAET) and Treatment as Usual (TAU) in people with Aquired Brain Injury and Stroke, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aquired Brain Injury, Stroke, MTBI - Mild Traumatic Brain Injury
- What is being tested?
- TAU + Group Therapy (EAET) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- 15 Sep 2026to Jun 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala
Jakob Nissen, Licensed Clinical Psychologist, 0046 18 611 24 85, jakob.nissen@akademiska.se
About this study
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.
Read the detailed description
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.
- Conditions
- Aquired Brain Injury, Stroke, MTBI - Mild Traumatic Brain Injury, mTBI, Encephalitis, Meningitis
- Being tested
- TAU + Group Therapy (EAET), Treatment as Usual (TAU)
- Keywords
- EAET, Emotional Awareness and Expression Therapy, Psychotherapy, Psychodynamic Psychotherapy
- Medical subject headings
- Stroke, Brain Concussion, Encephalitis, Meningitis, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAU + Group Therapy (EAET)Behavioural
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.
Treatment as Usual (TAU)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Treatment as Usual Receives: Behavioral: Treatment as Usual (TAU) |
| Arm 2 | Experimental | Treatment as Usual + Group Therapy (EAET) Receives: Behavioral: TAU + Group Therapy (EAET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Mentalized Affectivity Scale (B-MAS)
Evalutates three core components of emotion regulation: "Identifying emotions"; "Processing emotions", "Expressing emotions".
Measured: 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)
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."
Measured: 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)
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"
Measured: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Short Form 36 (SF-36)
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).
Measured: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Score of 0-64, with a higher score indicates worse symptoms.
Measured: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Insomnia Severity Index (ISI)
Score of 0-28, where higher scores indicate severity of insomnia.
Measured: 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)
Score of 0-15, where higher scores indicate severity of anxiety experienced.
Measured: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Patient Health Questionnaire-9 (PHQ-9)
Score of 0-27, where higher scores indicate severity of depression experienced.
Measured: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Patient Health Questionnaire-15 (PHQ-15)
Score of 0-30, where higher scores indicate severity and burden of common physical symptoms.
Measured: 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)
Score of 0-48, where higher score indicates higher avoidance.
Measured: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Behavioral Responses to Illness Questionnaire (BRIQ)
Evalutates behavioral response to illness on a four factor subscale: "All-or-Nothing Behavior", "Limiting Behavior", "Emotional Support Seeking" and "Practical Support Seeking".
Measured: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Alcohol Use Disorders Identification Test (AUDIT)
Score of 0-40, where higher score indicates greater risk of problematic alcohol use.
Measured: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Drug Use Disorders Identification Test (DUDIT)
Score of 0-44, where higher score indicates greater risk of problematic drug use.
Measured: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start15 Sep 2026
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Uppsala Public Health and Care
- Responsible party
- Sponsor
- Investigators
- Anna Nordström, M.D., Study chair, Uppsala UniversityPeter Nordström, Professor, Study chair, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852936
- Sponsor's protocol ID
- EAET after ABI
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No