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

NCT ID: NCT04082052

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2021-09-01

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

Conditions

Depressive Symptoms; Self-Appraisal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Single Session Intervention for Self-Dislike

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.

Group Type: EXPERIMENTAL

Single Session Interventions

Intervention Type: BEHAVIORAL

A single session intervention either active (for self-dislike) or placebo (feelings disclosure)

Single Session Intervention for Feelings Disclosure

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.

Group Type: PLACEBO_COMPARATOR

Single Session Interventions

Intervention Type: BEHAVIORAL

A single session intervention either active (for self-dislike) or placebo (feelings disclosure)

Interventions

Single Session Interventions

A single session intervention either active (for self-dislike) or placebo (feelings disclosure)

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Jessica Schleider

Assistant Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica L Schleider, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica L Schleider

Role: CONTACT

jessica.schleider@stonybrook.edu

6316324131

Facility Contacts

Jessica L Schleider, PhD

Role: primary

jessica.schleider@stonybrook.edu

631-632-4131

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IRB2019-00312

Identifier Type: -

Identifier Source: org_study_id