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E-Manage: A Brief mHelath Intervention for University Students

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Recruiting
CT.gov ID
NCT04636151
Collaborator
Massachusetts General Hospital (Other)
200
Enrollment
1
Location
3
Arms
18.8
Anticipated Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Ecological momentary intervention
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
E-Manage: A Brief mHelath Intervention for University Students
Actual Study Start Date :
Dec 4, 2020
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in momentary levels of self-reported distress [8 week study period]

    Assessed via smartphone assessments

Secondary Outcome Measures

  1. Change in momentary levels of suicidal thinking [8 week study period]

    Assessed via smartphone assessments

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rutgers Counseling, Alcohol and Other Drug Assistance Program & Psychiatric Services (CAPS) Piscataway New Jersey United States 08854

Sponsors and Collaborators

  • Rutgers, The State University of New Jersey
  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Evan Kleiman, Ph.D., Rutgers, The State University of New Jersey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Evan M. Kleiman, Ph.D., Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT04636151
Other Study ID Numbers:
  • Pro2020002347
First Posted:
Nov 19, 2020
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Suicidal Ideation

Study Results

No Results Posted as of Apr 5, 2022