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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUppsala University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • TAU + Group Therapy (EAET)

    Behavioral

    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)

    Behavioral

    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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Arm 1Active comparator 1 intervention
Group B: Arm 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Brief Mentalized Affectivity Scale (B-MAS)

Evalutates three core components of emotion regulation: "Identifying emotions"; "Processing emotions", "Expressing emotions".

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).

Secondary outcomes

1

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."

Time frame
Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
2

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"

Time frame
Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
3

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).

Time frame
Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
4

Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

Score of 0-64, with a higher score indicates worse symptoms.

Time frame
Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uppsala University

Lead sponsor

Region Uppsala Public Health and Care

Collaborator