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临床试验/NCT04264585
NCT04264585已完成不适用

Examining Motivational Interviewing and Booster Sessions in Internet-delivered Cognitive Behaviour Therapy for Post-secondary Students: An Implementation Trial

University of Regina2 个研究点 分布在 1 个国家目标入组 308 人开始时间: 2020年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
308
试验地点
2
主要终点
Patient Health Questionnaire 9-item (PHQ-9)

研究概览

简要总结

Post-secondary students are at an elevated risk for anxiety and depression, with approximately one in three students experiencing clinical levels of symptoms at some point during their academic career. Despite the high prevalence of these mental health concerns, many students do not receive adequate treatment. Internet-delivered cognitive behaviour therapy (ICBT) is an alternative to face-to-face service that is effective for improving symptoms of anxiety and depression in general adult populations. Recently, there has been increasing interest in the use of ICBT in post-secondary populations, however high drop-out rates and small effect sizes suggest that current ICBT programs are not fully meeting students' specific needs. Additional research is necessary to ensure that ICBT is delivered to students in a manner that is both acceptable and effective.

The proposed study will be an implementation trial to examine whether the efficacy of an ICBT course for post-secondary students is improved by offering a motivational interviewing component at pre-treatment and a booster session 1-month after completing treatment. Follow-up assessment will be conducted as 3-month post-treatment. Primary outcomes are anxiety, depression, and academic functioning. Implementation outcomes will include measures of the acceptability, adoption, and fidelity (assessed by number of modules completed) of the ICBT course.

详细描述

The aims of the study will be to: assess the efficacy of the UniWellbeing Course in reducing symptoms of anxiety and depression and increasing adjustment to academic and social responsibilities; to assess the impact of a pre-treatment motivational interviewing component on attrition, engagement, and outcomes (depression, anxiety, and academic functioning); to assess the impact of a booster session on anxiety, depression, and academic and social adjustment at three-month follow-up; and to assess the combined effect of including both a motivational interviewing component and booster session on outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • registered as a student at a post-secondary institution in Saskatchewan; over the age of 18;endorse symptoms of depression and/or anxiety; be able to access computers and the Internet and be comfortable using them; and willing to provide a physician as an emergency contact

排除标准

  • high risk of suicide or hospitalization for mental health in previous 12 months
  • unmanaged alcohol or drug use problems
  • severe psychiatric illness that is not managed (e.g. psychosis or mania)

结局指标

主要结局

Patient Health Questionnaire 9-item (PHQ-9)

时间窗: Baseline (screening), weeks 1-6, 9, and 17

Change in depression symptoms. 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.

Generalized Anxiety Disorder 7-item (GAD-7)

时间窗: Baseline (screening), weeks 1-6, 9, and 17

Change in anxiety symptoms. 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.

次要结局

  • Treatment credibility.(Baseline (screening), week 6)
  • Treatment satisfaction(Week 6)
  • Alcohol Use Disorders Identification Test (AUDIT)(Baseline (screening), week 6, and week 9)
  • Change Questionnaire(Pre-treatment)
  • Drug Use Disorders Identification Test (DUDIT)(Baseline (screening), week 6, and week 9)
  • Academic functioning(Baseline (screening), weeks 1-6, 9, and 17)
  • Sheehan Disability Scale (SDS)(Baseline (screening), week 6, 9, and 17)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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