NCT00610259已完成2 期
Brief Behavioral Therapy for Insomnia (bBT-I) for Depressed Outpatients With Refractory Insomnia - An Assessors-blinded, Randomized Controlled Effectiveness Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment
研究概览
简要总结
The purpose of this study is to examine the effectiveness of brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU) in comparison with TAU alone for refractory insomnia among patients with major depression in partial remission.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV major depressive disorder, as ascertained by the Structured Clinical Interview for DSM-IV Axis I disorders (SCID)
- •Either sex, between 20 and 70 years of age at the time of entry into the trial
- •Outpatient at the time of entry into the trial
- •For the index episode, patients have to have already been on two types of adequate doses of antidepressants for no shorter than 4 weeks for each medication or already on two types of antidepressants for 8 weeks in total even if the doses of the drugs have not been adequate due to side effects. The medication has not been changed for at least 4 weeks prior to the study entry.
- •A score of 2 on at least one of the three sleep items of the 17-GRID-HAMD and a score of 8 or more on the ISI.
- •A score between 8 and 23 on the 17-GRID-HAMD.
- •Agreement to the requirements that i) no change of medication will be allowed during the first 4 weeks of their study period, and ii) all the treatment sessions both of bBT-I and of TAU will be audiotaped for the purpose of checking their adherence to the protocol
排除标准
- •Their mental or physical status at the time of entry into the trial is regarded as so critical as to need immediate hospitalisation
- •A serious suicidal risk, defined as a score of 3 or more on item 3 (suicidal ideation) of the 17-GRID-HAMD
- •Patients who have had or are having any structured psychotherapy (e.g. cognitive therapy, or family therapy) at the time of entry
- •Patients with current diagnosis of primary anxiety or personality disorder, insomnia associated with another sleep disorder, significant medical problems, current drug or alcohol substance abuse or dependence, or psychosis, or with a history of schizophrenia or bipolar disorder
- •Patients with duration of depression shorter than 2 months
- •Their insomnia is considered to derive from sleep apnoea or periodic limb movements during sleep, judged by their clinicians.
- •Patients who engage in work involving night-shift, which might influence sleep status
- •Patients currently taking methylphenidate or modafinil.
结局指标
主要结局
Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment
时间窗: at 8-week
次要结局
- "No clinically significant insomnia" at the 8-week assessment, which is defined as 7 or less on the total ISI score(at 8-week)
- "No clinically significant insomnia" at the 4-week assessment, which is defined as 7 or less on the total ISI score(at 4-week)
- Changes in the total ISI score between the baseline and the 4-week assessment(at 4-week)
- Changes in the total score of the modified Pittsburgh Sleep Quality Index (PSQI) between the baseline and the 8-week assessment(at 8-week)
- Changes in the total score of the modified PSQI between the baseline and the 4-week assessment(at 4-week)
- Changes in the 17-item Hamilton Rating Scale for Depression (HAMD) between the baseline and the 8-week assessment(at 8-week)
- Changes in the 17- HAMD between the baseline and the 4-week assessment(at 4-week)
- Changes in the Short Form 36 (SF-36) scores between the baseline and the 8-week assessment(at 8-week)
- Changes in the SF-36 scores between the baseline and the 4-week assessment(at 4-week)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Brief Behavioral Intervention for Insomnia During ChemotherapyBreast CancerInsomniaNCT02165839Stanford University139
已完成
不适用
Efficacy of Behavioral Insomnia Treatment for Chronic MigraineChronic MigraineInsomniaNCT01314651Daniel Riche31
已完成
不适用
Nurse-led BBTI for Improving Insomnia SeverityInsomniaNCT05310136Taipei Medical University42
已完成
不适用
Cognitive Behavior Therapy for Insomnia (CBT-I) in Persons With Traumatic Brain Injury (TBI)TBIInsomniaNCT02709980Johns Hopkins University49
已完成
不适用
Brief Behavioral Insomnia Treatment StudyInsomnia DisorderNCT02571452VA Office of Research and Development93