Clinical trial NCT04082052: Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike
Official title: Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Self-Appraisal
Keywords: depression
self-dislike
self-compassion
symptom level
single session
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Change in Fear of Self-Compassion by Condition
timeFrame: Immediate pre intervention to 0-2 minute follow up post-intervention
measure: Change in Self-Hatred by Condition
timeFrame: Immediate pre intervention to one month follow-up
measure: Change in Individual Depressive Symptoms by Condition
timeFrame: Immediate pre intervention to one month follow-up
Secondary outcomes:
measure: Change in Verbally Expressed Emotion-Sadness
timeFrame: Immediate pre intervention to 0-2 minute follow up post-intervention
measure: Change in PHQ-9 Depression Symptoms
timeFrame: Immediate pre intervention to one month follow-up
measure: Change in the Self-Dislike Item of the BDI-II Depression Symptom
timeFrame: Immediate pre intervention to one month follow-up
measure: Change in Drinking to Cope Scale
timeFrame: Immediate pre intervention to one month follow-up
measure: Change in Social Phobia Screener
timeFrame: Immediate pre intervention to one month follow-up
measure: Change in Brief Emotional Intelligence Scale
timeFrame: Immediate pre intervention to one month follow-up
measure: Change in Empathy
timeFrame: Immediate pre intervention to one month follow-up
measure: Understanding of the Intervention: Self-report
timeFrame: 0-2 minute follow up post-intervention
measure: Effort Put Into the Intervention: Self-report
timeFrame: 0-2 minute follow up post-intervention
measure: Interest in the Intervention: Self-report
timeFrame: 0-2 minute follow up post-intervention
measure: Perceived Logicalness of the Intervention: Self-report
timeFrame: 0-2 minute follow up post-intervention
measure: Confidence in Recommending the Intervention to a Friend: Self-report
timeFrame: 0-2 minute follow up post-intervention
measure: Confidence in the Intervention Material's Ability to Improve Emotional Difficulties: Self-report
timeFrame: 0-2 minute follow up post-intervention
measure: Relevance to College Student's Lives: Self-report
timeFrame: 0-2 minute follow up post-intervention
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Jessica L Schleider, PhD
role: PRINCIPAL_INVESTIGATOR
References: