A Single-Session Intervention Fostering Emotional Nonreactivity

NCT ID: NCT07034027

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

545 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emotional Dysregulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study uses a two-group between-subjects design.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The measures and intervention will be self-administered, so there is no direct interaction between personnel and participants.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Project WAVE (Wise Awareness of Visiting Emotions)

Intervention Type BEHAVIORAL

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 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.

Group Type PLACEBO_COMPARATOR

Emotionally Neutral Writing Control

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Emotionally Neutral Writing Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Exit the study prior to condition randomization
* Fail to pass data integrity measures
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jessica Schleider

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwestern University

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jessica L Schleider, PhD

Role: CONTACT

9174391872

Riley McDanal, MA

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jessica L Schleider, PhD

Role: primary

9174391872

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15615668 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32602846 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31961194 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18310597 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU00223240

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AI-assisted GNW on Adolescent Emotional Distress
NCT07105137 ACTIVE_NOT_RECRUITING NA