Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Remission of Depression (%)
研究概览
简要总结
This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
详细描述
Difficulties falling and/or staying asleep are common in people who suffer from depression. Persistent insomnia can hinder response to treatment. In addition, individuals whose insomnia does not resolve with standard antidepressant therapy are at increased risk for recurrence of their depression. Between 60% and 84% of people who have major depressive disorder report symptoms of insomnia. This study will assess the efficacy of combining antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
Participants in this double-blind study will be randomly assigned to receive either desensitization therapy or cognitive behavioral therapy to target insomnia. All participants will also receive escitalopram oxalate, an antidepressant medication. The study will last 12 weeks. The severity of participants' depression and insomnia will be assessed. Study visits will occur weekly for the first 6 weeks, bi-weekly for the last 6 weeks, and once 6 months post-intervention.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depressive disorder
- •HRSD(17) score of at least 14
- •Presence and complaint of insomnia for at least 1 month
- •Fluent in English
- •Use of an effective form of contraception throughout the study
排除标准
- •Other psychiatric disorders (e.g., bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, eating disorder)
- •Psychotic symptoms
- •Serious, unstable, or terminal medical condition
- •Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder
- •Substance abuse
- •Not willing to end other psychiatric treatment
- •Previous electroconvulsive therapy or vagus nerve stimulation treatment during the last year
- •Sleep apnea, restless leg, or periodic limb movement disorder (to be ruled out after first sleep study)
- •Other sleep disorders
- •Currently pregnant or breastfeeding
- •History of seizure disorder
- •Disease or condition that produces altered metabolism or hemodynamic responses
- •Liver or kidney dysfunction
- •Current use of any over the counter medications or herbs for mood or sleep benefits (e.g., melatonin, valerian, kava, hop extract, St. John's Wort, SAMe)
研究组 & 干预措施
MED+CBTI
Escitalopram plus Cognitive Behavioral Therapy for Insomnia
干预措施: Escitalopram (Drug)
MED+CBTI
Escitalopram plus Cognitive Behavioral Therapy for Insomnia
干预措施: CBTI (Behavioral)
MED+CTRL
Escitalopram plus Pseudo-desensitization Therapy for Insomnia
干预措施: Escitalopram (Drug)
MED+CTRL
Escitalopram plus Pseudo-desensitization Therapy for Insomnia
干预措施: CTRL (Behavioral)
结局指标
主要结局
Remission of Depression (%)
时间窗: After 12 weeks or at the last available time point
Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID. The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms. The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains).
次要结局
- Remission of Insomnia(After 12 weeks or at the last available time point)
研究者
Rachel Manber
Dr. Rachel Manber
Stanford University