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临床试验/NCT04111887
NCT04111887已完成不适用

Depression Prevention Programs: A Pilot Trial

Oregon Research Institute1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2017年10月10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
91
试验地点
1
主要终点
Change from baseline Depressive Disorder Diagnostic using the Kiddie Schedule for Affective Disorders and Schizophrenia at 6 weeks, 3 months and 6 months

研究概览

简要总结

The purpose of this study is to compare the effectiveness of two depression prevention programs and a control brochure for college students. Participants may experience reductions in depressive symptoms and prevention of future depression.

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 28 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •current student at the University of Oregon
  • •subthreshold symptoms of depression, as indicated by a CES-D depression screener score of 20 or greater

排除标准

  • •current diagnosis of major depression
  • •acute suicidal ideation requiring immediate mental health treatment

研究组 & 干预措施

Change Ahead

Experimental

Each of the 6 weekly 1-hour sessions begins with a voluntary commitment to actively participate and to try something new in the upcoming week; includes a section devoted to selecting and publicly committing to one change focused on reducing negative/increasing positive cognitions and one change focused on increasing pleasant activities; and ends with home practice assignments. Additional exercises designed to increase dissonance induction include (a) group discussions for changing conditions, (b) roleplays to generate quick comebacks to written negative thoughts provided by other group members, (c) in-session writing exercises on the benefits of doing fun activities, (d) discussion of methods for creating internal and external accountability for positive change, (e) home practice assignment of engaging in actions to help someone else' mood, (f) writing a letter to my future self about positive intentions, and (g) providing positive feedback to other group members at the last session.

干预措施: Group-based therapy (Behavioral)

Blues Program

Active Comparator

The 6 weekly 1-hour sessions begin with a review of concepts and (after Session 1) review of past home practice assignments; all sessions conclude with home practice assignments. Each session has a portion devoted to thought identification/recording and cognitive restructuring and a portion devoted to increased involvement in pleasant activities. We use motivational enhancement exercises to maximize willingness to use the new skills, behavioral techniques to reinforce use of the new skills, and group activities to foster feelings of group cohesion.

干预措施: Group-based therapy (Behavioral)

Brochure control

Placebo Comparator

NIMH brochure that describes major depression and recommends treatment for depressed youth ("Let's Talk About Depression" NIH Pub. 01-4162), as well as information about local treatment options.

干预措施: Group-based therapy (Behavioral)

结局指标

主要结局

Change from baseline Depressive Disorder Diagnostic using the Kiddie Schedule for Affective Disorders and Schizophrenia at 6 weeks, 3 months and 6 months

时间窗: Measured at baseline, 6 weeks, 3 months and 6 months

Evaluate change (if any) by using the Kiddie Schedule for Affective Disorders and Schizophrenia at the 6 week, 3 month and 6 month marks.

Difference in future onset of Major Depressive Disorder using the Kiddie Schedule for Affective Disorders and Schizophrenia

时间窗: Measured at baseline, 6 weeks, 3 months and 6 months.

Evaluate difference (if any) in the future onset of Major Depressive Disorder at 3 months and 6 months.

Difference in attendance in Change Ahead vs Blues Program groups using group leader notes

时间窗: Measured at each group therapy session (6 weeks in total).

Evaluate difference (if any) in attendance in Change Ahead vs Blues Program group therapies by using group leader notes.

次要结局

  • Positive and negative thoughts(Measured at baseline, weeks 2,4 and 6.)
  • Negative life events(Measured at baseline)
  • Emotions(Measured at baseline, weeks 2,4 and 6.)
  • Assessments using writing samples(Measured at baseline and 6 weeks)
  • Depression and anxiety symptoms using the PHQ-9(Measured at baseline, 6 weeks, 3 months and 6 months)
  • Social adjustment in school, work, peer, spare time, and family domains(Measured at baseline, 6 weeks, 3 months and 6 months)
  • Depression and anxiety symptoms using the GAD-7(Measured at baseline, 6 weeks, 3 months and 6 months)
  • Health care utilization(Measured at baseline, 6 weeks, 3 months and 6 months)
  • Negative automatic thoughts(Measured at baseline, 6 weeks, 3 months and 6 months)
  • Substance use(Measured at baseline (in intake screener), 6 weeks, 3 months and 6 months)
  • Activity level(Measured at baseline, weeks 2,4 and 6.)
  • Negative attributional style(Measured at baseline, 6 weeks, 3 months and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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