跳至主要内容
临床试验/NCT06265701
NCT06265701已完成不适用

Decreasing Depressive Symptoms Through a Derailment-Focused Reflective Journaling Intervention

Cornell University2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2024年2月15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
116
试验地点
2
主要终点
Change from Pre-Assessment in Depressive Symptoms on the Beck Depression Inventory II (BDI-II) at Week 2 (Session 6/Post-Assessment)

研究概览

简要总结

The goal of this clinical trial is to explore the efficacy of a reflective journaling intervention-"Me Through Time"- in decreasing levels of derailment, and its impact on downstream depressive symptoms.

详细描述

The population will consist of those who: are considered as emergent adults (18-29 years) with at least moderate to severe depressive symptoms (a score of at least 20 on the BDI-II), moderate anxiety symptoms (a score of at least 10 on the GAD-7), and high levels of derailment (a score of at least 37 on the Derailment Scale).

Main research questions are as follows:

  • Does the "Me Through Time" journaling intervention predict decreased derailment and depressive symptoms at post-assessment compared to the severity of pre-assessment derailment and depressive symptoms?
  • Are post-assessment derailment and depressive symptoms lower for those who engaged in the "Me Through Time" journaling intervention compared to a control journaling intervention?

Participants will be asked to complete structured journal entries over the course of 5 sessions over 2 weeks, whereby each session addresses a different critical time period. These include: (1) first semester of college, (2) high school years, (3) middle school years, (4) early childhood, and finally (5) desired future. Participants will also be tasked with completing several assessment scales both before and after completing the "Me Through Time" journaling experience, as well as at the midway point.

The investigators will compare an experimental group engaging in the novel, derailment-focused "Me Through Time" journaling intervention with a control group engaging in a neutral, non-identity-based reflective journaling activity spanning the same time period as the "Me Through Time" intervention to see if post-assessment derailment and depressive symptoms are lower for those who engaged in the "Me Through Time" journaling intervention compared to the control journaling intervention.

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)

盲法说明

Investigators will utilize a single-blind approach where participants will not be made aware of the purpose of the intervention. Participants in both arms will be told that the purpose of the study is "to determine the efficacy of a novel five-session journaling intervention, which explores concepts related to self-continuity". This is partly true for those in the experimental arm. The main purpose of the study is twofold: (1) to explore the efficacy of the experimental journaling intervention's in reducing levels of derailment and (2) to test the hypothesis that decreasing derailment- a temporal discordance of the self- will lead to a decrease in depressive symptoms.

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be aged 18-
  • Participants must be fluent in English.
  • Participants must have attended at least one semester of college.
  • Participants must live in the United States
  • Participants must have a score on the Derailment Scale of at least 37 at pre-assessment.
  • Participants must have a score on the Beck Depression Inventory II of at least 20 at pre- assessment.
  • Participants must have a score on the GAD-7 of at least 10 at pre-assessment.
  • Participants must be willing and able to engage in a 2-week reflective journaling experience.

排除标准

  • Those outside of the specified age range.
  • Those who are not fluent in English.
  • Those who have not attended at least one semester of college.
  • Those who do not live in the United States.
  • Those who have a score on the Derailment Scale of less than 37 at pre-assessment.
  • Those have a score on the Beck Depression Inventory II of less than 20 at pre- assessment.
  • Those who have a score on the GAD-7 of less than 10 at pre-assessment.
  • Those who are neither willing nor able to engage in a 2-week reflective journaling experience.

结局指标

主要结局

Change from Pre-Assessment in Depressive Symptoms on the Beck Depression Inventory II (BDI-II) at Week 2 (Session 6/Post-Assessment)

时间窗: Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment)

The Beck Depression Inventory II is a validated, 21-item self-reported instrument assessing the severity of depression symptomatology in adolescents and adults. Items are summed to create a total score, whereby higher scores indicate higher levels of depressive symptoms. Scores range from 0-63, and a total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

Change from Pre-Assessment in Levels of Derailment on the Derailment Scale at Session 5

时间窗: Pre-Assessment (Baseline) and Session 5

The Derailment Scale is a validated, 10-item self-reported instrument that measures one's level of derailment - that is, one's perceptions of global change in self and direction. Possible scores range from 10-50, whereby higher scores indicate higher levels of derailment.

次要结局

  • Change from Pre-Assessment in Anxiety Symptoms on the Generalized Anxiety Disorder - 7 (GAD-7) at Week 2 (Session 6/Post-Assessment)(Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment))
  • Change from Pre-Assessment in Levels of Positive and Negative Affect on the Positive and Negative Affect Schedule (PANAS) at Week 2 (Session 6/Post-Assessment)(Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment))
  • Change from Pre-Assessment in Levels of Perceived Stress on the Perceived Stress Scale (PSS) at Week 2 (Session 6/Post-Assessment)(Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment))
  • Change from Pre-Assessment in Levels of Optimism Versus Pessimism on the Life Orientation Test - Revised (LOT - Revised) at Week 2 (Session 6/Post-Assessment(Baseline (Pre-Assessment) and Week 2 (Session 6/Post-Assessment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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