- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07852936
Group-based Emotional Awareness and Expression Therapy to Support Recovery After Acquired Brain Injury: A Clinical Development and Evaluation 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jakob Nissen, Licensed Clinical Psychologist
- Phone Number: 0046 18 611 24 85
- Email: jakob.nissen@akademiska.se
Study Locations
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-
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Uppsala, Sweden
- Recruiting
- Uppsala University Hospital
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Contact:
- Jakob Nissen, Licensed Clinical Psychologist
- Phone Number: 0046 18 611 24 85
- Email: jakob.nissen@akademiska.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm 1
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. |
|
Experimental: Arm 2
Treatment as Usual + 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Mentalized Affectivity Scale (B-MAS)
Time Frame: 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).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life after Brain Injury (QOLIBRI)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
|
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Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Anna Nordström, M.D., Uppsala University
- Study Chair: Peter Nordström, Professor, Uppsala University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Injuries, Traumatic
- Neuroinflammatory Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Wounds and Injuries
- Brain Ischemia
- Signs and Symptoms, Respiratory
- Craniocerebral Trauma
- Trauma, Nervous System
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Brain Injuries
- Hypoxia, Brain
- Hypoxia
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Stroke
- Brain Concussion
- Meningitis
- Encephalitis
- Hypoxia-Ischemia, Brain
- Psychotherapy
- Behavioral Disciplines and Activities
- Socioenvironmental Therapy
- Therapeutics
- Psychotherapy, Group
Other Study ID Numbers
- EAET after ABI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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