E-Manage: A Brief mHelath Intervention for University Students

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.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation; Distress, Emotional
• Intervention / Treatment: Behavioral: Ecological momentary intervention

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Rutgers Counseling, Alcohol and Other Drug Assistance Program & Psychiatric Services (CAPS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individual Treatment; Participants will have up to three individual sessions with a study therapist. One or more treatment modules will be presented in each session.	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.
Experimental: Group Treatment; Participants will have up to three group sessions with a study therapist. One or more treatment modules will be presented in each session.	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.
Experimental: Workshops; Participants will have one workshop with a study therapist. All three treatment modules will be presented in one session.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in momentary levels of self-reported distress	Assessed via smartphone assessments	8 week study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in momentary levels of suicidal thinking	Assessed via smartphone assessments	8 week study period

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: Evan Kleiman, Ph.D., Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2020
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: Pro2020002347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share the informed consent and de-identified data.
• IPD Sharing Time Frame: We will share the informed consent after the final participant has enrolled. We will share de-identified data one year after the study is finished.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No