Emotional DysregulationProject WAVENCT07034027
A Single-Session Intervention Fostering Emotional Nonreactivity
A study testing Project WAVE (Wise Awareness of Visiting Emotions) in people with Emotional Dysregulation, run by Northwestern University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Emotional Dysregulation
- What is being tested?
- Project WAVE (Wise Awareness of Visiting Emotions)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2025to 5 Aug 2025
- 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 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Fail to meet the above-listed inclusion criteria
- Exit the study prior to condition randomization
- Fail to pass data integrity measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Emotional Dysregulation
- Being tested
- Project WAVE (Wise Awareness of Visiting Emotions), Emotionally Neutral Writing Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project WAVE (Wise Awareness of Visiting Emotions)Behavioural
Project WAVE is an online, self-directed single-session intervention designed to foster emotional nonreactivity skills in young adults aged 18-29.
Emotionally Neutral Writing ControlBehavioural
The control condition is an online, self-directed single-session activity that includes an emotionally neutral writing task.
| Study group | Role | What they receive |
|---|---|---|
| Project WAVE (Wise Awareness of Visiting Emotions) | Experimental | 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. Receives: Behavioral: Project WAVE (Wise Awareness of Visiting Emotions) |
| Emotionally Neutral Writing Condition | Placebo comparator | 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. Receives: Behavioral: Emotionally Neutral Writing Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Intolerance Beliefs.
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.
Measured: Data will be collected in both conditions at all time points (pre-intervention, immediate post-intervention, and two-week follow-up).
Secondary outcomes (1)
Perceived Intervention Utility
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."
Measured: Data will be collected only in Project WAVE and only at immediate post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start16 Jul 2025
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Emotional DysregulationStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Model description
- This study uses a two-group between-subjects design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Schleider, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034027
- Sponsor's protocol ID
- STU00223240
- Acronym
- Project WAVE
- Status last verified
- Apr 2026
- First submitted
- 13 Jun 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 15615668Schleider 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.
PubMed 32602846Galla 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.
PubMed 31961194Baer 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.
PubMed 18310597
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Emotion Regulation Skills in Young Adults Using an Online Single-Session Intervention: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07034027
- Acronym / sponsor ID
- Project WAVE / STU00223240
- Conditions
- Emotional Dysregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 24 Jun 2025 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study uses a two-group between-subjects design.
| Arm | Type | Receives |
|---|---|---|
| Project WAVE (Wise Awareness of Visiting Emotions) | Experimental | Behavioral: 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. |
| Emotionally Neutral Writing Condition | Placebo comparator | Behavioral: Emotionally Neutral Writing ControlThe 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Fail to meet the above-listed inclusion criteria
- Exit the study prior to condition randomization
- Fail to pass data integrity measures
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 |
|---|---|---|
| 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. | Behavioural | Project WAVE (Wise Awareness of Visiting Emotions) |
| Emotionally Neutral Writing ControlThe control condition is an online, self-directed single-session activity that includes an emotionally neutral writing task. | Behavioural | Emotionally Neutral Writing Condition |
Primary outcome
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.
1 secondary outcome
Perceived Intervention Utility
Time frame: Data will be collected only in Project WAVE and only at immediate post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 15615668Taylor 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.
- Background: PubMed 32602846Schleider 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.
- Background: PubMed 31961194Galla 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.
- Background: PubMed 18310597Baer 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.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project WAVE (Wise Awareness of Visiting Emotions) in people with Emotional Dysregulation, run by Northwestern 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 0 inclusion and 3 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: finished, as of the sponsor's last update on 29 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07034027, which also lists 4 linked publications.
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 29 Apr 2026.