NCT07034027

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

July 16, 2025

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

20 days

First QC Date

June 13, 2025

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Data will be collected only in Project WAVE and only at immediate post-intervention.

Other Outcomes (2)

  • Nonreactivity to Emotions

    Data will be collected in both conditions at pre-intervention and two-week follow-up.

  • Program Feedback

    Data will be collected in both conditions only at immediate post-intervention.

Study Arms (2)

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.

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.

Behavioral: Emotionally Neutral Writing Control

Interventions

Project WAVE is an online, self-directed single-session intervention designed to foster emotional nonreactivity skills in young adults aged 18-29.

Project WAVE (Wise Awareness of Visiting Emotions)

The control condition is an online, self-directed single-session activity that includes an emotionally neutral writing task.

Emotionally Neutral Writing Condition

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • Exit the study prior to condition randomization
  • Fail to pass data integrity measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

  • 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.

    PMID: 15615668BACKGROUND
  • 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.

    PMID: 32602846BACKGROUND
  • 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.

    PMID: 31961194BACKGROUND
  • 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.

    PMID: 18310597BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The measures and intervention will be self-administered, so there is no direct interaction between personnel and participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study uses a two-group between-subjects design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 13, 2025

First Posted

June 24, 2025

Study Start

July 16, 2025

Primary Completion

August 5, 2025

Study Completion

August 5, 2025

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
ANALYTIC CODE

Locations