- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07034027
- Original Trial
A Single-Session Intervention Fostering Emotional Nonreactivity (Project WAVE)
April 27, 2026 updated by: Jessica Schleider, Northwestern University
Building Emotion Regulation Skills in Young Adults Using an Online Single-Session Intervention: A Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of a novel online single-session intervention (SSI) designed to improve emotion regulation abilities in young adults (ages 18-29).
The active intervention condition, titled "Project WAVE," uses mindfulness skills training and an emotion exposure to teach participants how to cope with distressing emotions.
Project WAVE will be evaluated in comparison with another online activity that controls for nonspecific aspects of single-session interventions.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
550
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
- Between the ages of 18 and 29, inclusive
- Self-report comfort in reading and writing in English
- Have access to the Internet through computer, laptop, smartphone, etc.
- Live in the United States or U.S. territories, per IP address
- Provide an endorsement of either "disagree" or "strongly disagree" on at least one of the following three items adapted from the Nonreactivity subscale of the Five Facet Mindfulness Questionnaire: "I was aware of my feelings and emotions without having to react to them"; "I watched my feelings without getting lost in them"; "When I had distressing emotions, I 'stepped back' and was aware of the emotion without getting taken over by it"
- Commit to providing thoughtful answers to the questions asked
- Pass the attention check / bot detection question, "Are you taller than 10 feet?" ("yes," "no," or "unsure") in the initial screener survey
Exclusion Criteria:
- Fail to meet the above-listed inclusion criteria
- Exit the study prior to condition randomization
- Fail to pass data integrity measures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Project WAVE (Wise Awareness of Visiting Emotions)
The active condition, "Project WAVE," (Wise Awareness of Visiting Emotions) includes 1) an introduction to the program's rationale; 2) psychoeducation about emotion dysregulation, avoidance, and exposure; 3) testimonials from others who describe their experience facing a difficult emotion; 4) an emotion exposure task along with an audio-guided nonreactivity practice; and 5) the creation of a personalized "action plan" usable for continued practice.
Project WAVE is designed to take approximately 15-20 minutes.
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Project WAVE is an online, self-directed single-session intervention designed to foster emotional nonreactivity skills in young adults aged 18-29.
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Placebo Comparator: Emotionally Neutral Writing Condition
The control condition is self-administered and structurally similar to Project WAVE (e.g., includes peer narratives and contains a similar number of writing activities).
It is designed to control for non-specific aspects of supportive online activities.
The activity involves an emotionally neutral writing task (journaling about daily life events).
This control condition is designed to take approximately 10-15 minutes.
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The control condition is an online, self-directed single-session activity that includes an emotionally neutral writing task.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotion Intolerance Beliefs.
Time Frame: Data will be collected in both conditions at all time points (pre-intervention, immediate post-intervention, and two-week follow-up).
|
Emotion intolerance beliefs will be measured using the Emotion Avoidance Questionnaire (EAQ) Beliefs subscale, a five-item self-report measure of a participant's beliefs about their inability to tolerate emotions (Taylor et al., 2004).
Participants will rate their agreement with each statement reflecting how they feel "right now" on a five-point scale.
A higher score indicates greater levels of negative beliefs about their ability to tolerate emotions.
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Data will be collected in both conditions at all time points (pre-intervention, immediate post-intervention, and two-week follow-up).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Intervention Utility
Time Frame: Data will be collected only in Project WAVE and only at immediate post-intervention.
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Perception of the intervention's utility in teaching nonreactivity will be assessed with the items: "During this activity, to what extent were you able to observe your emotions without getting caught up in them?"; "How much did this activity help you learn how to be nonreactive to distressing emotions?";
"How much do you think being nonreactive to distressing emotions could help you in the future?"
(each on a five-point Likert scale ranging from "not at all" to "very much"); and "How likely are you to try being nonreactive to distressing emotions in the future?"
(on a five-point Likert scale ranging from "very unlikely" to "very likely").
Participants will also be asked a multi-select question: "Did anything get in the way of being able to complete the nonreactivity practice?"
with response options including "It was too hard," "It was confusing," "I didn't find it interesting," "I got distracted," "Something else [write-in]," or "Nothing got in the way."
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Data will be collected only in Project WAVE and only at immediate post-intervention.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nonreactivity to Emotions
Time Frame: Data will be collected in both conditions at pre-intervention and two-week follow-up.
|
Nonreactivity to emotions will be measured using a three-item subset of the Five Facet Mindfulness Questionnaire (FFMQ) Nonreactivity subscale, a seven-item self-report measure of a participant's tendency to react to their emotions (Baer et al., 2008).
We are choosing to use a slightly modified three-item subset that has been used in previous research (Galla et al., 2020).
For the present purposes, we used "emotions" in place of the original "thoughts or images" because the intervention focuses both on thoughts and body sensations.
Participants in both conditions will rate their agreement with each statement reflecting how true each statement was for them over the past two weeks on a five-point scale.
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Data will be collected in both conditions at pre-intervention and two-week follow-up.
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Program Feedback
Time Frame: Data will be collected in both conditions only at immediate post-intervention.
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Similar to previous SSIs (e.g., Schleider et al., 2020), the perceived acceptability of the SSI will be measured using the Program Feedback Scale (PFS).
The PFS asks participants to rate agreement with seven statements about the acceptability of the SSI (e.g.
"I enjoyed the program") on a five-point scale.
A score of 3/5 or above on any given PFS item will be interpreted as an "acceptable" rating on that item (Schleider et al., 2020).
Scores are calculated at the item level, and higher scores reflect greater acceptability for each item.
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Data will be collected in both conditions only at immediate post-intervention.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.
- Taylor CT, Laposa JM, Alden LE. Is avoidant personality disorder more than just social avoidance? J Pers Disord. 2004 Dec;18(6):571-94. doi: 10.1521/pedi.18.6.571.54792.
- Schleider JL, Dobias M, Sung J, Mumper E, Mullarkey MC. Acceptability and Utility of an Open-Access, Online Single-Session Intervention Platform for Adolescent Mental Health. JMIR Ment Health. 2020 Jun 30;7(6):e20513. doi: 10.2196/20513.
- Galla BM, Tsukayama E, Park D, Yu A, Duckworth AL. The mindful adolescent: Developmental changes in nonreactivity to inner experiences and its association with emotional well-being. Dev Psychol. 2020 Feb;56(2):350-363. doi: 10.1037/dev0000877.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2025
Primary Completion (Actual)
August 5, 2025
Study Completion (Actual)
August 5, 2025
Study Registration Dates
First Submitted
June 13, 2025
First Submitted That Met QC Criteria
June 13, 2025
First Posted (Actual)
June 24, 2025
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- STU00223240
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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