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临床试验/NCT04634903
NCT04634903已完成不适用

Comparing Two Online Single-Session Interventions for Adolescent Depression: Outcomes of a Randomized Trial

Stony Brook University1 个研究点 分布在 1 个国家目标入组 2,452 人开始时间: 2020年11月19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
2,452
试验地点
1
主要终点
Change in Adolescent Depressive Symptom Severity

研究概览

简要总结

Most mental health problems emerge by age 14, often leading to chronic impairments and adverse impacts for individuals, families, and societies. Any action-focused path to reducing the need-to-access gap will require moving beyond the dominant settings, formats, and systems that have constrained intervention delivery to date. In a fully-online trial, youths ages 13-16 will be randomized to 1 of 3 self-administered single-session interventions (SSIs): a behavioral activation SSI, targeting behavioral MD symptoms; an SSI teaching growth mindset, targeting cognitive MD symptoms; or a control SSI. The investigators will test each SSI's relative benefits, versus the control, on depressive symptoms and proximal outcomes such as hopelessness. Results will reveal whether SSIs that were designed to address behavioral versus cognitive symptoms differentially benefit adolescents with elevated depressive symptoms.

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
Double (Participant, Investigator)

入排标准

年龄范围
13 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •are fluent in English
  • •have consistent internet and computer/laptop/smartphone access
  • •report elevated depressive symptoms (a score of >2 on the Patient Health Questionnaire-2 item version [PHQ-2])

排除标准

  • •fail to meet the above-listed inclusion criteria
  • •exit the study prior to condition randomization
  • •respond with either copy/pasted responses from text earlier in the intervention to any of free response questions
  • •obvious lack of English fluency in open response questions
  • •responding with random text in open response questions
  • •duplicate responses from the same individual in baseline or follow-up surveys
  • •We will also exclude for primary analyses (but may run sensitivity analyses including them) any participants who provide responses of fewer than 3 words to writing prompts that ask for at least 2 sentences or more.

研究组 & 干预措施

Supportive Therapy SSI (ST-SSI)

Active Comparator

The web-based supportive therapy (ST-SSI) intervention, called the Sharing Feelings Intervention, is designed to mimic supportive therapy (ST). The goals of the ST intervention are to encourage participants to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs. In previous clinical trials, ST has resulted in significantly fewer reductions in youth internalizing problems compared to cognitive-behavioral and growth mindset interventions. The ST-SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. It includes the same number of reading and writing activities as the other SSIs.

干预措施: Supportive Therapy SSI (Behavioral)

Behavioral Activation SSI (BA-SSI)

Experimental

The BA-SSI include 5 elements: (1) An introduction to the program's rationale: that engaging in value-based activities can combat sad mood and low self-esteem; (2) Psychoeducation about depression, including how behavior shapes feelings and thoughts; (3) A life values assessment, where youth identify key areas from which they draw enjoyment and meaning; (4) Creation of an activity hierarchy, where youth identify and personalize (in guided exercises) 3 activities to target for change; and (5) An exercise in which youths write about benefits that might result from engaging in each activity; an obstacle that might keep them from doing the activities; and a strategy for overcoming identified obstacles.

干预措施: Behavioral Activation SSI (Behavioral)

Growth Mindset SSI (GM-SSI)

Experimental

Program includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable Further stories by older youths, describing times when they used "growth mindsets" to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change.

干预措施: Growth Mindset SSI (Behavioral)

结局指标

主要结局

Change in Adolescent Depressive Symptom Severity

时间窗: Pre-SSI to 3-month follow-up

The Children's Depression Inventory (CDI) 2 - short form (CDI-SF) is a reliable, valid measure of youth depression severity, normed for youth age and sex and yielding raw scores ranging from 0-24, where higher scores indicate more severe symptoms of depression.

次要结局

  • Change in State Hope Scale - Pathways Subscale(Pre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up)
  • Change in Beck Hopelessness Scale - 4 Item Version(Pre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up)
  • Program Feedback Scale(Immediately Post-SSI only)

研究者

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

Jessica Schleider

Assistant Professor of Psychology

Stony Brook University

研究点 (1)

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