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

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ClinicalTrials.gov Identifier: NCT04082052
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jessica Schleider, Stony Brook University

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

Condition or disease Intervention/treatment Phase
Depressive Symptoms Self-Appraisal Behavioral: Single Session Interventions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 652 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The participants will be randomized by Qualtrics and will be unknown to the investigator and the patient until data collection is complete
Primary Purpose: Treatment
Official Title: Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Single Session Interventions
A single session intervention either active (for self-dislike) or placebo (feelings disclosure)

Placebo Comparator: 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.
Behavioral: Single Session Interventions
A single session intervention either active (for self-dislike) or placebo (feelings disclosure)




Primary Outcome Measures :
  1. Change in Fear of Self-Compassion by Condition [ Time Frame: 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.

  2. Change in Self-Hatred by Condition [ Time Frame: 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.

  3. Change in Individual Depressive Symptoms by Condition [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in Verbally Expressed Emotion-Sadness [ Time Frame: Immediate pre intervention to 0-2 minute follow up post-intervention ]
    Self-report average score of verbally expressed emotion-sadness scale. Participants rate 3 items reflecting their willingness to disclose sadness to others. Average scores range from 1-4. Higher scores indicate less willingness to disclose sadness to others.

  2. Change in PHQ-9 Depression Symptoms [ Time Frame: Immediate pre intervention to one month follow-up ]
    Self-report average score of depression symptoms on the PHQ-9 scale. Participants rate 9 items related to depression symptoms they've experienced in the past two weeks. Average scores range from 0-3. Higher scores indicate more depression symptoms

  3. Change in the Self-Dislike Item of the BDI-II Depression Symptom [ Time Frame: Immediate pre intervention to one month follow-up ]
    Self-report score of the BDI II Self-Dislike item. Participants rate 1 item related to self-dislike on a scale from 0-3. A higher score indicates more self-dislike.

  4. Change in Drinking to Cope Scale [ Time Frame: Immediate pre intervention to one month follow-up ]
    Self-report average score of the Drinking to Cope scale. Participants rate 5 items on how often they drink alcohol to cope with difficulties. Average scores range from 1-5. Higher scores indicate greater frequency in drinking to cope.

  5. Change in Social Phobia Screener [ Time Frame: Immediate pre intervention to one month follow-up ]
    Self-report average score of the Social Phobia Screener scale. Participants rate 5 items on how socially anxious they have been in the previous month. Average scores range from 0-4. Higher scores indicate more social anxiety

  6. Change in Brief Emotional Intelligence Scale [ Time Frame: Immediate pre intervention to one month follow-up ]
    Self-report average score of the Brief Emotional Intelligence scale. Participants rate 10 items reflecting their self-perceived emotional intelligence. Average scores range from 1-5. Higher scores indicate greater self-perceived emotional intelligence.

  7. Change in Empathy [ Time Frame: Immediate pre intervention to one month follow-up ]
    Self-report average score of the Mutual Psychological Development scale. Participants rate 22 items on how often they reacted in certain ways in the past ways when talking with others about things that mattered to them. Average scores range from 1-6. Higher scores indicate greater empathy.

  8. Understanding of the Intervention: Self-report [ Time Frame: 0-2 minute follow up post-intervention ]
    Self-report score on how much the participant understood the intervention. Participants rate 1 item on a scale from 1 to 5 on how well they understood the intervention. Higher scores indicate greater self-reported understanding of the intervention.

  9. Effort Put Into the Intervention: Self-report [ Time Frame: 0-2 minute follow up post-intervention ]
    Self-report score on how much self-reported effort the participant put into the intervention. Participants rate 1 item on a scale from 1 to 5 on how much effort they put into completing the intervention. Higher scores indicate greater self-reported effort put into the intervention.

  10. Interest in the Intervention: Self-report [ Time Frame: 0-2 minute follow up post-intervention ]
    Self-report score on how much self-reported interest the participant had about the intervention. Participants rate 1 item on a scale from 1 to 5 on how much interest they had in the intervention. Higher scores indicate greater self-reported interest in the intervention.

  11. Perceived Logicalness of the Intervention: Self-report [ Time Frame: 0-2 minute follow up post-intervention ]
    Self-report score on how logical the participant believed the intervention to be. Participants rate 1 item on a scale from 1 to 9 on how logical they believed the intervention to be. Higher scores indicate greater self-reported logicalness in the intervention.

  12. Confidence in Recommending the Intervention to a Friend: Self-report [ Time Frame: 0-2 minute follow up post-intervention ]
    Self-report score on how confident the participant would be in recommending the intervention to a friend who was struggling. Participants rate 1 item on a scale from 1 to 9 on how confident they would be in recommending these materials to a friend. Higher scores indicate greater self-reported confidence in recommending the intervention to a friend who was struggling.

  13. Confidence in the Intervention Material's Ability to Improve Emotional Difficulties: Self-report [ Time Frame: 0-2 minute follow up post-intervention ]
    Self-report score on how confident the participant is that the intervention will help improve their own emotional difficulties. Participants rate 1 item on a scale from 1 to 7 on how confident they are the intervention materials will improve their emotional difficulties. Higher scores indicate greater self-reported confidence that the intervention materials would improve their own emotional difficulties.

  14. Relevance to College Student's Lives: Self-report [ Time Frame: 0-2 minute follow up post-intervention ]
    Self-report score on how relevant the intervention is to college students. Participants rate 1 item on a scale from 1 to 7 on how relevant the intervention materials are to college students. Higher scores indicate greater self-reported relevance of the intervention to college students.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082052


Contacts
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Contact: Jessica L Schleider 6316324131 jessica.schleider@stonybrook.edu

Locations
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United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794-2500
Contact: Jessica L Schleider, PhD    631-632-4131    jessica.schleider@stonybrook.edu   
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Jessica L Schleider, PhD Stony Brook University
  Study Documents (Full-Text)

Documents provided by Jessica Schleider, Stony Brook University:
Statistical Analysis Plan  [PDF] September 4, 2019


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Responsible Party: Jessica Schleider, Assistant Professor of Psychology, Stony Brook University
ClinicalTrials.gov Identifier: NCT04082052     History of Changes
Other Study ID Numbers: IRB2019-00312
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be de-identified both by removing identifying information and any other procedures necessary to keep the data from being re-identified using known methods. The independent and dependent variables relevant to the primary outcomes will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Upon submission of the manuscript to a peer-reviewed journal (Anticipated date: 8-1-2020). The data will be available open access thereafter.
Access Criteria: The de-identified data will be shared open access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica Schleider, Stony Brook University:
depression
self-dislike
self-compassion
symptom level
single session
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms