Cognitive Behavioral Therapy for Insomnia vs Brief Behavioral Therapy for Insomnia in Military Personnel With Postconcussive Symptoms Following Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
This is a single site, two-armed random controlled trials (RCT) comparing six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I) in service members with comorbid insomnia and prolonged postconcussive symptoms present for at least 3 months after Mild Traumatic Brain Injury (mTBI).
详细描述
The purpose of this study is to identify the optimal behavioral treatment for insomnia in service members with comorbid insomnia and prolonged postconcussive symptoms following Mild Traumatic Brain Injury (mTBI). The study will compare Cognitive Behavioral Therapy for Insomnia (CBT-I) and Brief Behavioral Therapy for Insomnia (BBT-I) and determine the impact of behavioral insomnia treatment on insomnia symptom severity. This study will explore the impact of insomnia treatment on prolonged postconcussive symptoms and blood-based biomarkers. The overall objective is to determine if behavioral insomnia therapy can improve outcomes in service members with prolonged postconcussive symptoms following mTBI.
Both in-person and telehealth treatment formats will be offered to adapt to the service members schedule. The minimum acceptable number of sessions to the interventions in order to have evaluable data will be 4 sessions for CBT-I and 3 sessions for BBT-I. A participant is considered to have completed the study if he or she has completed the baseline assessment, at least 4 sessions for CBT-I and 3 sessions for BBT-I, and the 7-week and 12-week follow-up assessments.
Participants will be seen and treated at the Intrepid Spirit Center and/or the STRONG STAR offices both part of the Carl R. Darnall Army Medical Center (CRDAMC) located on the Fort Cavazos. Active duty service members at least 18 years of age who are seeking clinical care for persisting mTBI symptoms at the Intrepid Spirit Center located on Fort Cavazos. Women will be actively recruited into the study.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active duty U.S. military service members.
- •At least 18 years of age.
- •Ability to provide informed consent and follow study-related instructions.
- •Self-report of a Mild Traumatic Brain Injury (mTBI) at least 3 months prior to enrollment based on self-report.
- •At least 2 postconcussive symptoms scored > 2 (moderate) on the Neurobehavioral Symptom Inventory (NSI), with at least 1 of these symptoms from the cognitive domain in addition to the sleep disturbances item.
- •Clinically significant chronic insomnia disorder assessed by an independent evaluator using the Structured Clinical Interview for Sleep Disorders-Revised (SCISD-R)_No Split Week Self-Assessment of Sleep Survey (SASS-Y).
- •Minimum score of 15 on the Insomnia Severity Index (ISI).
- •Plans to be in the area for the next 3 months.
- •Stable on psychotropic and hypnotic medications for at least 1 month.
- •Stable on continuous positive airway pressure therapy if diagnosed with sleep apnea for at least 1 month.
排除标准
- •Moderate TBI (e.g., skull fracture, brain hemorrhage, hematoma) indicated by self-report or medical record.
- •Any sleep, medical, or psychiatric disorder requiring urgent treatment (e.g., suicide risk, substance use, insomnia with occupational impairment in high risk professions; very short sleep duration of less than 4 hours on average; bipolar disorder or psychosis) or that otherwise interferes with the completion of the baseline assessment.
- •Working night shifts (i.e., duty later than 9:00 pm or before 5:30 am) more than 3 times per month.
- •Planned major surgery.
- •Pregnancy, assessed by self-report and review of medical record.
研究组 & 干预措施
Cognitive Behavioral Therapy for Insomnia
6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
Brief Behavioral Therapy for Insomnia
4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
干预措施: Brief Behavioral Therapy for Insomnia (Behavioral)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. Each item on the ISI is rated on a 5-point Likert scale, ranging from 0 (no problem) to 4 (very severe problem), leading to a total possible score between 0 and 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Neurobehavioral Symptom Inventory (NSI)
时间窗: Baseline, 7 Week Follow-up, 12 Week Follow-up
The NSI is a 22-item self-report measure that assesses postconcussive symptoms and classifies them into vestibular, somatic, cognitive, and affective factors, and indicates symptom severity. Respondents rate the severity of each symptom on a scale from 0 (none) to 4 (very severe). Total scores range between 0-88.
NIH Toolbox v3
时间窗: Baseline, 7 Week Follow-up
The NIH Toolbox Cognition Domain measures several aspects of cognitive functioning, including language, episodic memory, executive function, working memory and processing speed. It is a battery administered and automatically scored on the iPad, assessing cognitive function. Higher scores indicate higher levels of functioning compared nationally. A score around 130 suggest superior ability, around 115 suggest above-average fluid cognitive ability, around 100 is average compared with others nationally, around 85 suggests significantly below-average, 70 or below suggests very low functioning.
次要结局
- Dysfunctional Beliefs and Attitudes about Sleep (DBAS)(Baseline, 7 Week Follow-up, 12 Week Follow-up)
- Nightmare Disorder Index (NDI)(Baseline, 7 Week Follow-up, 12 Week Follow-up)
- Epworth Sleepiness Scale (ESS)(Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up)
- Patient Health Questionnaire (PHQ-9)(Baseline, 7 Week Follow-up, 12 Week Follow-up)
- Multidimensional Fatigue Inventory (MFI-20)(Baseline, 7 Week Follow-up, 12 Week Follow-up)
- Headache Impact Test (HIT-6)(Baseline, 7 Week Follow-up, 12 Week Follow-up)
- General Anxiety Disorder (GAD-7)(Baseline, 7 Week Follow-up, 12 Week Follow-up)
- Depressive Symptoms Index-Suicidality Subscale (DSI-SS)(Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up)
研究者
Kristi Pruiksma
Associate Professor
The University of Texas Health Science Center at San Antonio