Phase 2 Study of Neuropsychological Therapy for Patients With Acquired Brain Injury Focusing on the Role of Psychosocial Adjustment Using a Cognitive Behavioral Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- Psychosocial Adjustment/ Everyday Functioning as a composite score of SCL-90-R and AFIB
研究概览
简要总结
Acquired brain injury can result in impaired everyday functioning as well as psychosocial problems, including depressive symptoms, irritability, or negative self-concept. The purpose of this study is to determine whether a combination of neuropsychological and cognitive behavioral therapy is effective in the treatment of these sequelae.
详细描述
Acquired brain injury (ABI) commonly results in persistent cognitive, emotional and motivational problems. About 50% of patients involved develop psychiatric illness, most likely in the first year following ABI, which is associated with reduced psychosocial functioning and less favorable rehabilitation outcome. Treatment of these complex conditions requires a combination of neuropsychological and psychotherapeutic intervention techniques.
This study aims at evaluating a combination of neuropsychological intervention methods, which include developing and using compensation strategies for cognitive impairments (attention, memory and executive functions), and psychotherapeutic intervention focusing on emotion regulation, developing positive self-concepts and adjustment of life-goals. These therapeutic interventions are modularized and patients are assigned to intervention modules according to results of objective neuropsychological testing and interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having suffered an acquired brain injury after the age of 14, such as traumatic brain injury, neoplasm (after surgery), toxic brain damage, or brain damages through inflammatory diseases
- •Being at least 3 months post injury
- •Being German-speaking
- •Agreeing to participate, verified by completion of informed consent
排除标准
- •Suffering from recurrent, degenerative, or progressive neurological diseases (e.g. multiple sclerosis, dementia, Chorea Huntington)
- •Current or past psychosis or bipolar disorder
- •Current or past diagnosis of substance dependency
- •History of mental retardation
- •Currently in psychotherapy
- •Severe lateralized disorder (e.g. aphasia, neglect)
- •Lacking minimum basic skills for attending therapy (e.g. not orientated to person, place, time, and events; unable to sustain attention for an hour-long session; cannot state cognitive strengths and weaknesses; cannot state areas in everyday functioning that are impaired due to the acquired brain injury)
结局指标
主要结局
Psychosocial Adjustment/ Everyday Functioning as a composite score of SCL-90-R and AFIB
时间窗: Pre-/ Post-Design, including 3 ponts of measurement: at the beginning of therapy/ waiting period; immediately after completion of therapy/ waiting period; catamnestic measurement 6 months later
次要结局
- Quality of Life (Qolibri, Seiqol, SWLS)(Pre-/ Post-Design, including 3 points of measurement: at the beginning of therapy/ waiting period; immediately after completion of therapy/ waiting period; catamnestic measurement 6 months later)
- Psychopathology/ Affect (ADS; PANAS)(Pre-/ Post-Design, including 3 points of measurement: at the beginning of therapy/ waiting period; immediately after completion of therapy/ waiting period; catamnestic measurement 6 months later)
- Community Integration (CIQ)(Pre-/ Post-Design, including 3 points of measurement: at the beginning of therapy/ waiting period; immediately after completion of therapy/ waiting period; catamnestic measurement 6 months later)
- Self-concept/ Life Goals (HISDS II; GOALS; RSES-REV; Self-complexity Measure; FSKN)(Pre-/ Post-Design, including 3 points of measurement: at the beginning of therapy/ waiting period; immediately after completion of therapy/ waiting period; catamnestic measurement 6 months later)
研究者
Winfried Rief
Prof. Dr. Winfried Rief
Philipps University Marburg Medical Center