Cognitive Behavioral Therapy for Depression After Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Symptom Checklist-20 (SCL-20)
研究概览
简要总结
The purpose of this study is to test the effectiveness of a telephone-based and in-person Cognitive Behavioral Therapy (CBT) intervention for treating Major Depressive Disorder (MDD) following Traumatic Brain Injury. Participants are randomly assigned to receive one of the following: 1) Telephone-based CBT, 2) In-person CBT, or 3) Usual care (control).
详细描述
Major Depressive Disorder (MDD) is the most prevalent psychiatric disorder in persons with traumatic brain injury (TBI) and is most common during the first several years after injury. MDD following TBI is associated with poor behavioral, health, and functional outcomes. While neurological factors contribute somewhat to the development of MDD in this population, there is evidence that numerous psychological, social and vocational factors also contribute.
There are also multiple barriers to effective treatment of MDD in persons with TBI, including:
- under-diagnosis and under-treatment 20lack of access to care due to mobility, transportation and health care benefit limitations
- TBI neurocognitive impairments
- comorbid medical and psychiatric problems, including substance abuse
- stressors such as lack of social support and work instability
- inaccurate beliefs about depression and its treatment among TBI survivors.
The investigators are conducting a three arm trial of Cognitive Behavioral Therapy (CBT) to treat Major Depression Disorder (MDD) that emerges within the first 10 years after complicated mild to severe traumatic brain injury (TBI). The overall objective of the study is to develop a 12-session telephone-based and in-person CBT program for people with TBI (CBT-TBI), and to evaluate its feasibility, acceptability, and effectiveness.
The investigators project aims are to
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospitalized for TBI within the last 10 years, and at least one month post-injury
- •sustained a complicated mild to severe TBI as indicated by Glasgow Coma Scale score of 3-12 or had documented intracranial abnormalities on CT scan or had post-traumatic amnesia (PTA) of at least 7 days
- •meet screening criteria for major depression
- •speak English fluently
- •resides in any of the the 50 United States
排除标准
- •does not have a telephone
- •does not have a stable address
- •history of bipolar disorder or schizophrenia, or current psychosis or suicidal intent
- •current alcohol or substance dependence (within last month)
- •evidence of significant cognitive impairment on neuropsychological testing
- •started on an antidepressant medication within 6 weeks or planning to start on an antidepressant within the 16-week study
- •currently in psychotherapy for depression or plan to start psychotherapy for depression within the 16-week study period
- •refusal to participate
研究组 & 干预措施
Telephone-based CBT
- 12 counseling sessions over 16 weeks over the telephone
干预措施: Telephone Cognitive Behavioral Therapy (Behavioral)
In-person CBT
- 12 counseling sessions over 16 weeks at either Harborview Medical Center or the University of Washington Medical Center in Seattle, WA
干预措施: In-person Cognitive Behavioral Therapy (Behavioral)
3: Usual care
- No counseling sessions as part of this study, however you are free to pursue regular medical care and counseling outside of this study
结局指标
主要结局
Symptom Checklist-20 (SCL-20)
时间窗: 16 weeks, 24 weeks
Hamilton Rating Scale for Depression (HAM-D)
时间窗: 16 weeks, 24 weeks
次要结局
- Automatic Thoughts Questionnaire(16 weeks)
- Structured Clinical Interview for DSM-IV (SCID)- Current MDD only(16 weeks, 24 weeks)
- Dysfunctional Attitudes Scale(16 weeks)
- Patient Health Questionnaire-9 (PHQ-9)(16 weeks, 24 weeks)
- Head Injury Symptom Checklist(16 weeks, 24 weeks)
- Medical Outcome Short Form- 36 (SF-36)(16 weeks, 24 weeks)
- Environmental Reward Observation Scale (EROS)(16 weeks)
- Sheehan Disability Scale(16 weeks, 24 weeks)
研究者
Jesse Fann
Professor
University of Washington