E-Manage: A Brief mHelath Intervention for University Students

Suicidal Ideation Clinical Trial

Official title:

E-Manage: A Brief mHelath Intervention for University Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04636151
• Other study ID #: Pro2020002347
• Status: Completed
• Phase: N/A
• Start date: December 4, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a two-part transdiagnostic psychological intervention aimed to help people respond to negative emotion and emotional distress in more adaptive ways using a technology called "ecological momentary intervention" (or EMI) that delivers intervention content using a smartphone app. Participants in this study will be Rutgers students recruited through-or currently affiliated with - Counseling, Alcohol and Other Drug Assistance Program & Psychiatric Services (CAPS) at Rutgers. Participants will first attend either one-on-one or group telehealth therapy sessions/workshops, where they will learn the therapeutic skills that are part of the study. Then, they will complete up to 8 weeks of smartphone monitoring that involves assessments and opportunities to practice the skills learned in therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Age 18 years or older

• Matriculated at Rutgers during Fall of 2020 (on campus and/or remote)

• Currently residing in US

• Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures

• iOS and Android smartphone compatible with MetricWire. Nearly all phones since 2014 are compatible

Exclusion Criteria

• Non-English speaking

• Unable to understand or provide informed consent

Related Conditions & MeSH terms

• Distress, Emotional
• Suicidal Ideation

Intervention

Behavioral:
• Ecological momentary intervention
Content of this intervention is based on pre-established transdiagnostic protocols for addressing the negative emotion associated with suicidal thoughts and behaviors.

Locations

Country	Name	City	State
United States	Rutgers Counseling, Alcohol and Other Drug Assistance Program & Psychiatric Services (CAPS)	Piscataway	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in momentary levels of self-reported distress	Assessed via smartphone assessments	8 week study period
Secondary	Change in momentary levels of suicidal thinking	Assessed via smartphone assessments	8 week study period