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临床试验/NCT01598922
NCT01598922已完成不适用

Internet Based Cognitive Behavioral Therapy Effects on Depressive Cognitions and Brain Function

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17).

研究概览

简要总结

The purpose of this study is to understand the effectiveness of a ten-week internet-based cognitive behavioral therapy (iCBT) treatment on improving depressive symptoms, coping and resilience skills, and cognitive processing.

详细描述

The need for mental health services is high among military personnel but perceived stigma and other barriers prevent many Soldiers from obtaining the help they need. Alternative mental health treatment approaches that mitigate stigma and increase access and compliance are greatly needed. One promising treatment approach that has shown efficacy in preliminary research and which may address issues related to stigma and barriers to care, is internet-based cognitive behavioral therapy (iCBT). Internet-based treatments offer brief, interactive, and structured treatment approaches that can be completed by individuals relatively anonymously, in the convenience and privacy of their own homes, and according to their own schedules. Such interventions could offer Soldiers an alternative treatment method that minimizes stigma by allowing private and quasi-anonymous access to treatment and which minimizes barriers to care by enhancing access and maximizing schedule flexibility.

Emerging evidence suggests that iCBT is a particularly promising and well-accepted approach for treating large numbers of individuals while minimizing cost and clinicians' time demand. The study of internet-based and other computer-assisted therapies is currently in its infancy and most studies still lack sufficient methodological rigor to firmly establish the efficacy and applicability of these approaches. The proposed project will provide the most comprehensive evaluation of iCBT to date by employing functional neuroimaging techniques, neurocognitive testing of implicit negative biases and responses to negative feedback, and assessment of resilience and coping capacities in addition to standard symptom-based outcome measures.

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

  • •Age range between 18 and
  • •Subjects must be right handed (as measured by Edinburgh Handedness Inventory).
  • •The primary language of the subjects must be English
  • •Must have regular access to a computer with internet connection and printer (for potential MDD or MAC participants)
  • •DSM-IV criteria for current Major Depressive Episode according to SCID (for enrollment into MDD or MAC groups)
  • •Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine; 6 months for neuroleptics; 2 weeks for benzodiazepines; 2 weeks for any other antidepressants)
  • •PHQ-9 score below 5 (for enrollment into HC group)

排除标准

  • •Any history of neurological illness or brain injury
  • •Current or past DSM-IV Axis I disorder (for enrollment into HC group)
  • •Complicating medical conditions that may influence the outcome of neuropsychological assessment or functional imaging (e.g., HIV)
  • •Mixed or left-handedness
  • •Abnormal visual acuity that is not corrected by contact lenses
  • •Metal within the body, claustrophobia, or other contraindications for MRI
  • •Less than 9th grade education
  • •Past or current alcohol/substance dependence, or current alcohol abuse, or current or past substance abuse (i.e. past alcohol abuse is not exclusionary)
  • •Use of illicit drugs within the past year
  • •Use of marijuana within the past month
  • •Current use of opioid or prescribed stimulant medications
  • •History of a psychotic mental illness (schizophrenia or bipolar disorder)
  • •Current severe symptoms of depression (total score > 23 or responding > 1 to Question 9 for suicidal ideation in the Patient Health Questionnaire-9 Item [PHQ-9] (Kroenke et al., 2001))
  • •A PHQ-9 score below 10 (for potential MDD or MAC participants)
  • •Currently participating in Cognitive Behavior Therapy
  • •History of ECT treatment

研究组 & 干预措施

Internet Cognitive Behavioral Therapy

Experimental

Participants with major depressive disorder receive an 8-week long internet-based cognitive behavioral therapy program.

干预措施: Internet Cognitive Behavioral Therapy (Behavioral)

Monitored Attention Control

No Intervention

Participants with major depressive disorder receive no treatment but are monitored closely for 8 weeks. Participants in this arm are offered the treatment at the end of the study.

结局指标

主要结局

Change From Pre-treatment to Post-treatment (10 Weeks), Measured by the Hamilton Rating Scale for Depression, 17 Item Version (HRSD-17).

时间窗: Measured at the baseline visit and 10 weeks after the baseline visit

To assess change in severity of depression symptoms. The total score is reported, which is the sum of the ratings of all items and ranges from 0 to 52, with higher scores indicating a worse outcome or greater severity of depression symptoms.

次要结局

  • Weekly Patient Health Questionnaire (PHQ-9) Score(Baseline visit, and 10 weeks after baseline visit)
  • Improvement From Baseline in Brain Functioning on the Emotional Interference Task (EIT) and the Monetary Incentive Delay Task (MID)(baseline, 10 weeks)
  • Change From Baseline in Implicit Association Test (IAT)(Baseline visit, 10 weeks after baseline visit.)
  • Weekly Kessler Psychological Distress Scale (K-10) Score(Week 10 score)
  • Change From Baseline in Positive and Negative Affect Scale (PANAS) Score(Baseline visit and 10 weeks after baseline visit)
  • Change From Baseline in Connor Davidson Resilience Scale (CD-RISC) Score(Baseline visit, and 10 weeks after baseline visit)
  • Change From Baseline in Modified Erikson Flanker Test(Baseline visit and 10 weeks after baseline visit.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Scott Rauch

President and Psychiatrist-in-Chief

Mclean Hospital

研究点 (1)

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