E-Manage: A Brief mHelath Intervention for University Students

January 19, 2023 updated by: Evan M. Kleiman, Ph.D., Rutgers, The State University of New Jersey
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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Recruiting
        • Rutgers Counseling, Alcohol and Other Drug Assistance Program & Psychiatric Services (CAPS)
        • Contact:
        • Principal Investigator:
          • Evan M Kleiman, Ph.D.
        • Sub-Investigator:
          • Annmarie Wacha-Montes, PsyD
        • Sub-Investigator:
          • Kate H Bentley, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 8 week study period
Assessed via smartphone assessments
8 week study period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2020

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

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)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

  • Informed Consent Form (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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