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

Stony Brook University

Status: Unknown

Conditions: Self-Appraisal; Depressive Symptoms

Treatments: Behavioral: Single Session Interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT04082052

IRB2019-00312

Details and patient eligibility

About

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

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,800 participants in 2 patient groups, including a placebo group

Single Session Intervention for Self-Dislike

Experimental group

Description:

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.

Treatment:

Behavioral: Single Session Interventions

Single Session Intervention for Feelings Disclosure

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Single Session Interventions