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临床试验/NCT06130020
NCT06130020已完成不适用

Comparing Targets of Expressive Writing

Trustees of Princeton University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年11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
发起方
入组人数
160
试验地点
1
主要终点
Anxiety

研究概览

简要总结

Expressive writing involves writing about one's deepest thoughts and feelings surrounding an emotional event. The current literature on the efficacy of expressive writing is mixed and warrants further investigation into how, when, and for whom expressive writing is an effective intervention. The goal of this study is to compare the efficacy of expressive writing interventions in young adults when people imagine that they're writing to themselves vs. a loved one. Participants will carry out an expressive writing exercise for 14 consecutive days. Participants are randomized into 3 groups: Self, Other, and Control. The Self group is instructed to write as if they were talking to themselves. The Other group is instructed to direct their writing to someone they feel close to. The Control group is asked to write down a factual description of their routine that day, and direct this writing to themselves. We will recruit participants until we have usable data from 53 participants per group (i.e., 159 in total).

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
Single (Participant)

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

  • Fluent English
  • Combined GAD-7 and PHQ-8 score of ≥ 5

排除标准

  • "Completion" of a writing session requires participants to spend at least 15 minutes on the writing page. We will monitor completion of the daily writing exercise, and will contact participants who miss or spend less than 15 minutes on the exercise. Participants who fail to complete 3 consecutive daily writing sessions will be deemed non-compliant, removed from the study, and paid a prorated amount for the tasks they have completed in the study.

研究组 & 干预措施

Self

Experimental

The Self group is instructed to carry out the expressive writing exercise as if they were writing to themselves.

干预措施: Expressive Writing: Self (Behavioral)

Other

Experimental

The Other group is instructed to carry out the expressive writing exercise as if they were writing to someone they feel close to.

干预措施: Expressive Writing: Other (Behavioral)

Control

Placebo Comparator

The Control group is asked to write down a factual description of their routine that day, as if they were writing to themselves.

干预措施: Factual Writing (Behavioral)

结局指标

主要结局

Anxiety

时间窗: Initial visit (day 1), mid-point (day 7) final visit (day 15), 1-month follow-up (1 month after day 14)

Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0-21, with higher scores indicating more severe anxiety.

Depression

时间窗: Initial visit (day 1), mid-point (day 7), final visit (day 15), 1-month follow-up (1 month after day 14)

Patient Health Questionnaire-8 (PHQ-8). Scores range from 0-24, with higher scores indicating more severe depression.

次要结局

未报告次要终点

研究者

发起方
Trustees of Princeton University
申办方类型
Other
责任方
Sponsor
主要研究者

Erik Nook

Assistant Professor

Trustees of Princeton University

研究点 (1)

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