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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Project WAVE (Wise Awareness of Visiting Emotions)
Project WAVE is an online, self-directed single-session intervention designed to foster emotional nonreactivity skills in young adults aged 18-29.
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.
Behavioral: Emotionally Neutral Writing Control
The control condition is an online, self-directed single-session activity that includes an emotionally neutral writing task.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Data will be collected in both conditions at all time points (pre-intervention, immediate post-intervention, and two-week follow-up).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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."
Data will be collected only in Project WAVE and only at immediate post-intervention.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.
Data will be collected in both conditions at pre-intervention and two-week follow-up.
Program Feedback
Time Frame: Data will be collected in both conditions only at immediate post-intervention.
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.
Data will be collected in both conditions only at immediate post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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