Treatment Resistant Depression and Insomnia in Older Veterans: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- PHQ-9 ( depression)
研究概览
简要总结
The purpose of this pilot study is to obtain information about older Veterans' preferences for treatment of depression and insomnia and to pilot test the feasibility and clinical effect of Brief Behavioral Treatment for Insomnia (BBTI) BBTI for older Veterans living with Treatment Resistant Depression (TRD) and insomnia.
详细描述
Quantitative and qualitative methods will be used to obtain information to aid in developing treatment approaches appropriate for older Veterans with TRD and insomnia. Qualitative data will be gathered to better understand Veterans' preferences for treatment approaches, particularly relating to preference for pharmacotherapy versus augmentation with a behavioral intervention such as BBTI. Using a Randomized Controlled Trial (RCT) design, we will test whether augmentation with BBTI will be acceptable to older Veterans and improve treatment response in those whose depression has not improved with antidepressant pharmacotherapy alone and assess for an association between preference and treatment response. Our aims and hypotheses are:
Aim 1: To characterize the depression, insomnia, and relevant clinical and neuropsychiatric characteristics of older Veterans with TRD.
H1a: In Veterans with TRD, Antidepressant History Form (ATHF) scores will have a positive association with Montgomery-Asberg Depression Rating scale (MADRS) scores.
H1b: In Veterans with TRD, MADRS scores will have a positive association with Insomnia Severity Index (ISI) scores.
Aim 2: Perform qualitative interviews in older Veterans to collect information about their views of their depression and insomnia and attitudes and preferences for treatment of both depression and insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major Depressive Disorder (MDD)
- •Diagnosis of Insomnia Disorder
- •Must have failed ≥ 1 antidepressant trial
排除标准
- •Lifetime/current Bipolar I/II diagnosis
- •Lifetime/current Schizophrenia Spectrum Disorder diagnosis
- •Substance Use Disorder within past 3 months
- •High Suicide Risk that cannot be safely managed
- •Untreated Obstructive Sleep Apnea (OSA)
- •Restless Legs Syndrome
- •Rapid Eye Movement (REM) Sleep Behavior Disorder
- •Active OR untreated Post Traumatic Stress Disorder (PTSD)
结局指标
主要结局
PHQ-9 ( depression)
时间窗: 8 weeks
ISI score ( insomnia)
时间窗: 8 weeks
次要结局
- Short Form Survey (SF-12) SF-12 ( quality of life)(8 weeks)
- Emotional Closeness Questionnaire ( ECQ)(8 weeks)