- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jakob Nissen, Licensed Clinical Psychologist
- 전화번호: 0046 18 611 24 85
- 이메일: jakob.nissen@akademiska.se
연구 장소
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Uppsala, 스웨덴
- 모병
- Uppsala University Hospital
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연락하다:
- Jakob Nissen, Licensed Clinical Psychologist
- 전화번호: 0046 18 611 24 85
- 이메일: jakob.nissen@akademiska.se
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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. |
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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Brief Mentalized Affectivity Scale (B-MAS)
기간: 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).
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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).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of Life after Brain Injury (QOLIBRI)
기간: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
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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.
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Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)
기간: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
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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.
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Short Form 36 (SF-36)
기간: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
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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.
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Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
기간: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
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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.
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Insomnia Severity Index (ISI)
기간: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
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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)
기간: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
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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.
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Patient Health Questionnaire-9 (PHQ-9)
기간: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
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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.
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Patient Health Questionnaire-15 (PHQ-15)
기간: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
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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.
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Fear Avoidance Behavior after Traumatic Brain Injury Questionnaire (FAB-TBI)
기간: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
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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.
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Behavioral Responses to Illness Questionnaire (BRIQ)
기간: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
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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.
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Alcohol Use Disorders Identification Test (AUDIT)
기간: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
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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.
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Drug Use Disorders Identification Test (DUDIT)
기간: Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.
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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.
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공동 작업자 및 조사자
수사관
- 연구 의자: Anna Nordström, M.D., Uppsala University
- 연구 의자: Peter Nordström, Professor, Uppsala University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EAET after ABI
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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