跳至主要内容
临床试验/NCT03345459
NCT03345459Unknown不适用

College Mental Health Project

Mclean Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Patient Health Questionnaire-9 (PHQ-9) administered at post-treatment

研究概览

简要总结

Depression is common and debilitating disorder which, among college students, is predictive of significant problems including higher rates of dropout and suicidal behaviors. Despite viable psychotherapeutic and pharmacological options, the majority of depressed college students, like others in the general population, do not pursue treatment. Further, barriers to care, both those involving practical issues and psychological factors, lead to high attrition rates from treatment, resulting in modest effect sizes in effectiveness trials. In reaction to these alarming figures and as a means of increasing accessibility and retention, effective internet-based treatment for depression have been developed and tested. Despite increased availability, response to internet-based treatment continues to vary substantially, yet, controlled trials show that a meaningful proportion of patients who receive internet-based therapy recover. Identifying individuals with a high likelihood of responding to internet-based treatment would enable clinicians to target this inexpensive treatment only to the patients with a high probability of responding; allowing more intensive treatments to be reserved for patients who would not respond to internet-based therapy. The development of a system to make this determination would represent a major advance and address an unmet need.

ICare is an online depression treatment that has been adapted for college students (e.g., language used, problems discussed, embedded images). Prior work by the developers of ICare have tested the internet-based treatment in diverse samples of depressed adults, and prior meta-analytic research has demonstrated that psychological treatments for depression in college students are as effective relative to trials carried out among depressed adults. The overarching goal of the study is to: (a) test whether depressed college students utilize ICare, (b) identify psychosocial and clinical characteristics that increase the likelihood of ICare utilization, and (c) identify multivariate characteristics that predict treatment response.

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 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-25 years;
  • Enrolled as a first year student at a participating institution;
  • English fluency;
  • Mild or Moderate Depression: (i) PHQ-9 score 10-14 or (ii) PHQ-9 score 15-19;
  • Provide Online Consent Form.

排除标准

  • Severe Depression: (i) PHQ-9 score ≥20;
  • Endorse "3" (nearly every day) on item 9 of the PHQ-9;
  • No internet access

结局指标

主要结局

Patient Health Questionnaire-9 (PHQ-9) administered at post-treatment

时间窗: Assess depressive symptoms over the prior 2 weeks.

Self-report questionnaire assessing depression symptoms during the past 2 weeks. Scores on the PHQ-9 range from 0-27. Lower scores are indicative of less severe depressive symptoms.

Generalized Anxiety Disorder - 7 item (GAD-7) administered at post-treatment

时间窗: Assess anxious symptoms over the prior 2 weeks.

Self-report questionnaire assessing anxiety symptoms during the past 2 weeks. Scores on the GAD-7 range from 0-21. Lower scores are indicative of less severe anxious symptoms.

EuroQol 5 (EQ-5D) administered at post-treatment

时间窗: Examines problems/symptoms over the prior 2 weeks.

Comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 items is rated on a scale from 1 to 3, and then summed to a total score. Lower scores are indicative of less severe problems.

次要结局

未报告次要终点

研究者

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

Randy P. Auerbach

Director

Mclean Hospital

研究点 (2)

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