跳至主要内容
临床试验/NCT04082052
NCT04082052Unknown不适用

Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike

Stony Brook University1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2019年9月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
1,800
试验地点
1
主要终点
Change in Individual Depressive Symptoms by Condition

研究概览

简要总结

The investigators are testing whether a single session online intervention for self-dislike decreases:

  1. Fear of self-compassion from immediate pre to immediate post intervention
  2. Self-hatred immediate pre to 1 month post-intervention
  3. Individual depression symptoms immediate pre to 1 month post-intervention more than a placebo online single session intervention encouraging the disclosure of feelings in college students.

The investigators will also explicitly test whether the following variables are predictors, of at least the smallest variance predicted of interest, of response to treatment vs. placebo on self-hatred: 4. Pre intervention self-hatred score 5. Screening positive for clinical depression based on self-report 6. Immediate pre to post-intervention reduction in fear of self-compassion 7. The investigators will also assess whether any of the variance shared between the treatment and changes in individual depression symptoms immediately pre Intervention to 1 month post-intervention is statistically mediated by change in self-hatred from immediate pre intervention to 1 month post 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
Triple (Participant, Care Provider, Investigator)

盲法说明

The participants will be randomized by Qualtrics and will be unknown to the investigator and the patient until data collection is complete

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Participant is a current college student at the time of study enrollment
  • •Participant has not previously taken part in the study
  • •Participant speaks English well enough to complete online intervention activities, which are available in English only
  • •Participant is comfortable with completing online surveys and programs
  • •Participant is at least 18 years of age.

排除标准

  • •The investigators will exclude participants 3 SDs above/below the mean completion time for the study or exit the study prior to randomization for our listed analyses.
  • •The investigators will also test whether there's any association between how quickly participants are responding to questions and the variability in their responses. If there is a response time frame (i.e., a series of questions that require answers where timing is measured) where there is a linear relationship between response time and response variability, the investigators may exclude those participants, as response time and response variability should be uncorrelated and a linear association can indicate random responding. This time frame can be identified visually on a graph, and sensitivity tests can be conducted to determine if slight variations on the visual interpretation affect substantive results.
  • •The investigators will exclude participants who respond with either copy/pasted responses from text earlier in the intervention (e.g. Copy and pasting only text from a previous testimonial slide) to any of free response questions.
  • •The investigators will exclude for primary analyses (but may run sensitivity analyses including them) any participants who provide responses of 5 words or fewer to writing prompts that ask for at least 1 sentence or more.

研究组 & 干预措施

Single Session Intervention for Self-Dislike

Experimental

A 30-45 minute intervention delivered in a web browser that focuses on reducing self-dislike using facts about the brain, testimonials from peers, and writing exercises.

干预措施: Single Session Interventions (Behavioral)

Single Session Intervention for Feelings Disclosure

Placebo Comparator

A 30-45 minute intervention delivered in a web browser that focuses on encouraging feelings disclosure using facts about the brain, testimonials from peers, and writing exercises.

干预措施: Single Session Interventions (Behavioral)

结局指标

主要结局

Change in Individual Depressive Symptoms by Condition

时间窗: Immediate pre intervention to one month follow-up

Self-report average score from the individual symptoms on the IDAS-II Dysphoria scale. Participants rate 10 items on a scale reflecting their experience of depression symptoms that all load onto one latent factor. Average scores range from 1-5. Higher scores indicate experiencing more of a given symptom.

Change in Fear of Self-Compassion by Condition

时间窗: Immediate pre intervention to 0-2 minute follow up post-intervention

Self-report average score from the fear of self-compassion scale. Participants rate 15 items on a scale reflecting different fears/barriers to being self-compassionate they experience. Average scores range from 1-5. Higher scores indicate a greater fear of self-compassion.

Change in Self-Hatred by Condition

时间窗: Immediate pre intervention to one month follow-up

Self-report average score from the self-hatred scale. Participants rate 7 items on a scale reflecting their levels of self-dislike/self-hatred. Average scores range from 1-7. Higher scores indicate a greater self-hatred.

次要结局

  • Change in Verbally Expressed Emotion-Sadness(Immediate pre intervention to 0-2 minute follow up post-intervention)
  • Change in PHQ-9 Depression Symptoms(Immediate pre intervention to one month follow-up)
  • Change in the Self-Dislike Item of the BDI-II Depression Symptom(Immediate pre intervention to one month follow-up)
  • Effort Put Into the Intervention: Self-report(0-2 minute follow up post-intervention)
  • Change in Drinking to Cope Scale(Immediate pre intervention to one month follow-up)
  • Perceived Logicalness of the Intervention: Self-report(0-2 minute follow up post-intervention)
  • Change in Social Phobia Screener(Immediate pre intervention to one month follow-up)
  • Change in Brief Emotional Intelligence Scale(Immediate pre intervention to one month follow-up)
  • Change in Empathy(Immediate pre intervention to one month follow-up)
  • Understanding of the Intervention: Self-report(0-2 minute follow up post-intervention)
  • Interest in the Intervention: Self-report(0-2 minute follow up post-intervention)
  • Confidence in Recommending the Intervention to a Friend: Self-report(0-2 minute follow up post-intervention)
  • Confidence in the Intervention Material's Ability to Improve Emotional Difficulties: Self-report(0-2 minute follow up post-intervention)
  • Relevance to College Student's Lives: Self-report(0-2 minute follow up post-intervention)

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)

Loading locations...

相似试验