NCT07852936

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
56mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress1%
Sep 2026Jun 2031

Study Start

First participant enrolled

September 15, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

4.7 years

First QC Date

September 25, 2026

Last Update Submit

September 25, 2026

Conditions

Keywords

EAETEmotional Awareness and Expression TherapyPsychotherapyPsychodynamic Psychotherapy

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 COMPARATOR

Treatment as Usual

Behavioral: Treatment as Usual (TAU)

Arm 2

EXPERIMENTAL

Treatment as Usual + Group Therapy (EAET)

Behavioral: TAU + 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.

Arm 2

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.

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

StrokeBrain ConcussionEncephalitisMeningitisHypoxia-Ischemia, Brain

Interventions

Psychotherapy, GroupTherapeutics

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Injuries, TraumaticBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingNeuroinflammatory DiseasesBrain IschemiaHypoxia, BrainHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Anna Nordström, M.D.

    Uppsala University

    STUDY CHAIR
  • Peter Nordström, Professor

    Uppsala University

    STUDY CHAIR

Central Study Contacts

Jakob Nissen, Licensed Clinical Psychologist

CONTACT

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

Locations