Back to resultsEvaluating and Predicting Response to a Single Session Intervention for Self-Dislike (GOALS)
Primary Purpose
Depressive Symptoms, Self-Appraisal
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single Session Interventions
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Symptoms focused on measuring depression, self-dislike, self-compassion, symptom level, single session
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.
Sites / Locations
- Stony Brook UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Single Session Intervention for Self-Dislike
Single Session Intervention for Feelings Disclosure
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change in Fear of Self-Compassion by Condition
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
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.
Change in Individual Depressive Symptoms by Condition
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
Change in Verbally Expressed Emotion-Sadness
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.
Change in PHQ-9 Depression Symptoms
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
Change in the Self-Dislike Item of the BDI-II Depression Symptom
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.
Change in Drinking to Cope Scale
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.
Change in Social Phobia Screener
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
Change in Brief Emotional Intelligence Scale
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.
Change in Empathy
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.
Understanding of the Intervention: Self-report
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.
Effort Put Into the Intervention: Self-report
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.
Interest in the Intervention: Self-report
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.
Perceived Logicalness of the Intervention: Self-report
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.
Confidence in Recommending the Intervention to a Friend: Self-report
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.
Confidence in the Intervention Material's Ability to Improve Emotional Difficulties: Self-report
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.
Relevance to College Student's Lives: Self-report
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.
Full Information
NCT ID
NCT04082052
First Posted
August 29, 2019
Last Updated
October 5, 2020
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT04082052
Brief Title
Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike
Acronym
GOALS
Official Title
Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators are testing whether a single session online intervention for self-dislike decreases:
Fear of self-compassion from immediate pre to immediate post intervention
Self-hatred immediate pre to 1 month post-intervention
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:
Pre intervention self-hatred score
Screening positive for clinical depression based on self-report
Immediate pre to post-intervention reduction in fear of self-compassion
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Self-Appraisal
Keywords
depression, self-dislike, self-compassion, symptom level, single session
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
The participants will be randomized by Qualtrics and will be unknown to the investigator and the patient until data collection is complete
Allocation
Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Session Intervention for Self-Dislike
Arm Type
Experimental
Arm 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.
Arm Title
Single Session Intervention for Feelings Disclosure
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Single Session Interventions
Intervention Description
A single session intervention either active (for self-dislike) or placebo (feelings disclosure)
Primary Outcome Measure Information:
Title
Change in Fear of Self-Compassion by Condition
Description
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.
Time Frame
Immediate pre intervention to 0-2 minute follow up post-intervention
Title
Change in Self-Hatred by Condition
Description
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.
Time Frame
Immediate pre intervention to one month follow-up
Title
Change in Individual Depressive Symptoms by Condition
Description
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.
Time Frame
Immediate pre intervention to one month follow-up
Secondary Outcome Measure Information:
Title
Change in Verbally Expressed Emotion-Sadness
Description
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.
Time Frame
Immediate pre intervention to 0-2 minute follow up post-intervention
Title
Change in PHQ-9 Depression Symptoms
Description
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
Time Frame
Immediate pre intervention to one month follow-up
Title
Change in the Self-Dislike Item of the BDI-II Depression Symptom
Description
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.
Time Frame
Immediate pre intervention to one month follow-up
Title
Change in Drinking to Cope Scale
Description
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.
Time Frame
Immediate pre intervention to one month follow-up
Title
Change in Social Phobia Screener
Description
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
Time Frame
Immediate pre intervention to one month follow-up
Title
Change in Brief Emotional Intelligence Scale
Description
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.
Time Frame
Immediate pre intervention to one month follow-up
Title
Change in Empathy
Description
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.
Time Frame
Immediate pre intervention to one month follow-up
Title
Understanding of the Intervention: Self-report
Description
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.
Time Frame
0-2 minute follow up post-intervention
Title
Effort Put Into the Intervention: Self-report
Description
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.
Time Frame
0-2 minute follow up post-intervention
Title
Interest in the Intervention: Self-report
Description
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.
Time Frame
0-2 minute follow up post-intervention
Title
Perceived Logicalness of the Intervention: Self-report
Description
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.
Time Frame
0-2 minute follow up post-intervention
Title
Confidence in Recommending the Intervention to a Friend: Self-report
Description
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.
Time Frame
0-2 minute follow up post-intervention
Title
Confidence in the Intervention Material's Ability to Improve Emotional Difficulties: Self-report
Description
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.
Time Frame
0-2 minute follow up post-intervention
Title
Relevance to College Student's Lives: Self-report
Description
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.
Time Frame
0-2 minute follow up post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica L Schleider
Phone
6316324131
Email
jessica.schleider@stonybrook.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica L Schleider, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-2500
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica L Schleider, PhD
Phone
631-632-4131
Email
jessica.schleider@stonybrook.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing 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.
IPD Sharing Access Criteria
The de-identified data will be shared open access
Learn more about this trial
Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike
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