E-Manage: A Brief mHelath Intervention for University Students

NCT04636151 | Completed

• 1 other identifier: Pro2020002347
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Distress, Emotional; Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• Change in momentary levels of self-reported distress

  Assessed via smartphone assessments

  8 week study period

Secondary Outcomes (1)

• Change in momentary levels of suicidal thinking

  8 week study period

Study Arms (3)

Individual Treatment

EXPERIMENTAL

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

Group Treatment

EXPERIMENTAL

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

Workshops

EXPERIMENTAL

Participants will have one workshop with a study therapist. All three treatment modules will be presented in one session.

Behavioral: Ecological momentary intervention

Interventions

Ecological momentary intervention BEHAVIORAL

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

Group Treatment; Individual Treatment; Workshops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking
• Unable to understand or provide informed consent

Sponsors & Collaborators

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

Study Sites (1)

Rutgers Counseling, Alcohol and Other Drug Assistance Program & Psychiatric Services (CAPS)

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Evan Kleiman, Ph.D.

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: December 4, 2020
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• 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.

Locations

US (1)