Depressive SymptomsGOALSNCT04082052
Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike
A study testing Single Session Interventions in people with Depressive Symptoms and Self-Appraisal, run by Stony Brook University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Self-Appraisal
- What is being tested?
- Single Session Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University
Stony Brook, New York, 11794-2500
Jessica L Schleider, PhD, 631-632-4131, jessica.schleider@stonybrook.edu
About this study
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
- Conditions
- Depressive Symptoms, Self-Appraisal
- Being tested
- Single Session Interventions
- Keywords
- depression, self-dislike, self-compassion, symptom level, single session
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Session InterventionsBehavioural
A single session intervention either active (for self-dislike) or placebo (feelings disclosure)
| Study group | Role | What they receive |
|---|---|---|
| Single Session Intervention for Self-Dislike | Experimental | 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. Receives: Behavioral: Single Session Interventions |
| Single Session Intervention for Feelings Disclosure | Placebo comparator | 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. Receives: Behavioral: Single Session Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate pre intervention to 0-2 minute follow up post-intervention
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.
Measured: Immediate pre intervention to one month follow-up
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.
Measured: Immediate pre intervention to one month follow-up
Secondary outcomes (14)
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.
Measured: Immediate pre intervention to 0-2 minute follow up post-intervention
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
Measured: Immediate pre intervention to one month follow-up
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.
Measured: Immediate pre intervention to one month follow-up
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.
Measured: Immediate pre intervention to one month follow-up
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
Measured: Immediate pre intervention to one month follow-up
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.
Measured: Immediate pre intervention to one month follow-up
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.
Measured: Immediate pre intervention to one month follow-up
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.
Measured: 0-2 minute follow up post-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.
Measured: 0-2 minute follow up post-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.
Measured: 0-2 minute follow up post-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.
Measured: 0-2 minute follow up post-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.
Measured: 0-2 minute follow up post-intervention
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.
Measured: 0-2 minute follow up post-intervention
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.
Measured: 0-2 minute follow up post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start23 Sep 2019
- Primary completion31 May 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Schleider, Stony Brook University
- Investigators
- Jessica L Schleider, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082052
- Sponsor's protocol ID
- IRB2019-00312
- Acronym
- GOALS
- Status last verified
- Oct 2020
- First submitted
- 29 Aug 2019
- Last updated
- 6 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike
- ClinicalTrials.gov ID
- NCT04082052
- Acronym / sponsor ID
- GOALS / IRB2019-00312
- Conditions
- Depressive Symptoms, Self-Appraisal
- Keywords
- depression, self-dislike, self-compassion, symptom level, single session
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Session Intervention for Self-Dislike | Experimental | Behavioral: Single Session InterventionsA 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. |
| Single Session Intervention for Feelings Disclosure | Placebo comparator | Behavioral: Single Session InterventionsA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Session InterventionsA single session intervention either active (for self-dislike) or placebo (feelings disclosure) | Behavioural | Single Session Intervention for Feelings Disclosure, Single Session Intervention for Self-Dislike |
Primary outcome
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.
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.
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.
14 secondary outcomes
Change in Verbally Expressed Emotion-Sadness
Time frame: Immediate pre intervention to 0-2 minute follow up post-intervention
Change in PHQ-9 Depression Symptoms
Time frame: Immediate pre intervention to one month follow-up
Change in the Self-Dislike Item of the BDI-II Depression Symptom
Time frame: Immediate pre intervention to one month follow-up
Change in Drinking to Cope Scale
Time frame: Immediate pre intervention to one month follow-up
Change in Social Phobia Screener
Time frame: Immediate pre intervention to one month follow-up
Change in Brief Emotional Intelligence Scale
Time frame: Immediate pre intervention to one month follow-up
Change in Empathy
Time frame: Immediate pre intervention to one month follow-up
Understanding of the Intervention: Self-report
Time frame: 0-2 minute follow up post-intervention
Effort Put Into the Intervention: Self-report
Time frame: 0-2 minute follow up post-intervention
Interest in the Intervention: Self-report
Time frame: 0-2 minute follow up post-intervention
Perceived Logicalness of the Intervention: Self-report
Time frame: 0-2 minute follow up post-intervention
Confidence in Recommending the Intervention to a Friend: Self-report
Time frame: 0-2 minute follow up post-intervention
Confidence in the Intervention Material's Ability to Improve Emotional Difficulties: Self-report
Time frame: 0-2 minute follow up post-intervention
Relevance to College Student's Lives: Self-report
Time frame: 0-2 minute follow up post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica L Schleider, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Session Interventions in people with Depressive Symptoms and Self-Appraisal, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica L Schleider (6316324131, jessica.schleider@stonybrook.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fear of Self-Compassion by Condition (time frame: Immediate pre intervention to 0-2 minute follow up post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020; AzTrials last refreshed its copy on 31 Oct 2026.