跳至主要内容
临床试验/NCT05651295
NCT05651295招募中不适用

A Precision Medicine Approach to Target Engagement for Emotion Regulation

Matthew Southward, PhD2 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2023年9月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
390
试验地点
2
主要终点
Changes in Positive and Negative Affect Schedule-Short Form

研究概览

简要总结

The proposed study is designed to first test whether teaching people personalized or standardized emotion regulation skills leads to greater decreases in daily negative emotion intensity. Second, using data from an initial sample, the investigators will prospectively assign an independent sample of participants to receive their predicted optimal or non-optimal skills to determine if it is feasible and efficacious to match participants to the most appropriate training condition. Results of these studies may identify the mechanisms by which emotion regulation interventions impact emotional functioning and allow for the development of personalized, evidence-based, and scalable emotion regulation interventions.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elevated emotion dysregulation

排除标准

  • Lack of proficiency in English
  • No access to smartphone
  • Conditions requiring greater than outpatient care

研究组 & 干预措施

Personalized Condition

Active Comparator

Participants will learn one of three emotion regulation skills (i.e., cognitive restructuring, opposite to emotion action, mindfulness) that is their personal strength, based on pre-Baseline emotion regulation capacities. They will watch an interactive video, created for the current study, in which they are taught the skill that is their personal strength. They will also be asked to complete a survey during the video in which they will input their own examples to practice the skill and to ensure attention to and comprehension of the material.

干预措施: Checking the Facts (Behavioral)

Personalized Condition

Active Comparator

Participants will learn one of three emotion regulation skills (i.e., cognitive restructuring, opposite to emotion action, mindfulness) that is their personal strength, based on pre-Baseline emotion regulation capacities. They will watch an interactive video, created for the current study, in which they are taught the skill that is their personal strength. They will also be asked to complete a survey during the video in which they will input their own examples to practice the skill and to ensure attention to and comprehension of the material.

干预措施: Opposite to Emotion Action (Behavioral)

Personalized Condition

Active Comparator

Participants will learn one of three emotion regulation skills (i.e., cognitive restructuring, opposite to emotion action, mindfulness) that is their personal strength, based on pre-Baseline emotion regulation capacities. They will watch an interactive video, created for the current study, in which they are taught the skill that is their personal strength. They will also be asked to complete a survey during the video in which they will input their own examples to practice the skill and to ensure attention to and comprehension of the material.

干预措施: Mindfulness of Current Emotions (Behavioral)

Standardized Condition

Active Comparator

Participants will learn all three ER skills: cognitive restructuring, opposite to emotion action, and mindfulness. Participants will be asked to watch three interactive videos that cover each skill to provide an analogue to clinical practice in which clinicians must choose whether to provide greater breadth or depth of skill coverage. These videos will be presented in a randomized order and will include the same surveys for attention and comprehension used in the Personalized Condition.

干预措施: Checking the Facts (Behavioral)

Standardized Condition

Active Comparator

Participants will learn all three ER skills: cognitive restructuring, opposite to emotion action, and mindfulness. Participants will be asked to watch three interactive videos that cover each skill to provide an analogue to clinical practice in which clinicians must choose whether to provide greater breadth or depth of skill coverage. These videos will be presented in a randomized order and will include the same surveys for attention and comprehension used in the Personalized Condition.

干预措施: Opposite to Emotion Action (Behavioral)

Standardized Condition

Active Comparator

Participants will learn all three ER skills: cognitive restructuring, opposite to emotion action, and mindfulness. Participants will be asked to watch three interactive videos that cover each skill to provide an analogue to clinical practice in which clinicians must choose whether to provide greater breadth or depth of skill coverage. These videos will be presented in a randomized order and will include the same surveys for attention and comprehension used in the Personalized Condition.

干预措施: Mindfulness of Current Emotions (Behavioral)

结局指标

主要结局

Changes in Positive and Negative Affect Schedule-Short Form

时间窗: 7 times per day for 42 days

A self-report measure designed to assess the intensity of momentary negative affect. Scores range from 1 to 5, with higher scores indicating greater negative affect and lower scores indicating less negative affect.

次要结局

  • Changes in Hamilton Depression Rating Scale(Once every 2 weeks for 6 weeks (4 times total))
  • Changes in emotion regulation effectiveness(7 times per day for 48 days)
  • Changes in Hamilton Anxiety Rating Scale(Once every 2 weeks for 6 weeks (4 times total))
  • Changes in Five-Factor Model Score Sheet(Once every 2 weeks for 6 weeks (4 times total))
  • Changes in Ways of Responding Scale(Once every 2 weeks for 6 weeks (4 times total))
  • Changes in Opposite to Emotion Action Task(Once every 2 weeks for 6 weeks (4 times total))
  • Changes in Breath-Counting Task(Once every 2 weeks for 6 weeks (4 times total))

研究者

发起方
Matthew Southward, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthew Southward, PhD

Assistant Professor

Ohio State University

研究点 (2)

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