Back to resultsE-Manage: A Brief mHelath Intervention for University Students
Primary Purpose
Distress, Emotional, Suicidal Ideation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ecological momentary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Distress, Emotional
Eligibility Criteria
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
Sites / Locations
- Rutgers Counseling, Alcohol and Other Drug Assistance Program & Psychiatric Services (CAPS)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Individual Treatment
Group Treatment
Workshops
Arm Description
Participants will have up to three individual sessions with a study therapist. One or more treatment modules will be presented in each session.
Participants will have up to three group sessions with a study therapist. One or more treatment modules will be presented in each session.
Participants will have one workshop with a study therapist. All three treatment modules will be presented in one session.
Outcomes
Primary Outcome Measures
Change in momentary levels of self-reported distress
Assessed via smartphone assessments
Secondary Outcome Measures
Change in momentary levels of suicidal thinking
Assessed via smartphone assessments
Full Information
NCT ID
NCT04636151
First Posted
November 13, 2020
Last Updated
January 19, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04636151
Brief Title
E-Manage: A Brief mHelath Intervention for University Students
Official Title
E-Manage: A Brief mHelath Intervention for University Students
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distress, Emotional, Suicidal Ideation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individual Treatment
Arm Type
Experimental
Arm Description
Participants will have up to three individual sessions with a study therapist. One or more treatment modules will be presented in each session.
Arm Title
Group Treatment
Arm Type
Experimental
Arm Description
Participants will have up to three group sessions with a study therapist. One or more treatment modules will be presented in each session.
Arm Title
Workshops
Arm Type
Experimental
Arm Description
Participants will have one workshop with a study therapist. All three treatment modules will be presented in one session.
Intervention Type
Behavioral
Intervention Name(s)
Ecological momentary intervention
Intervention Description
Content of this intervention is based on pre-established transdiagnostic protocols for addressing the negative emotion associated with suicidal thoughts and behaviors.
Primary Outcome Measure Information:
Title
Change in momentary levels of self-reported distress
Description
Assessed via smartphone assessments
Time Frame
8 week study period
Secondary Outcome Measure Information:
Title
Change in momentary levels of suicidal thinking
Description
Assessed via smartphone assessments
Time Frame
8 week study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evan Kleiman
Phone
8484452345
Email
evan.kleiman@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Kleiman, Ph.D.
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Counseling, Alcohol and Other Drug Assistance Program & Psychiatric Services (CAPS)
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annmarie Wacha-Montes, PsyD
Email
aw440@echo.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Evan M Kleiman, Ph.D.
First Name & Middle Initial & Last Name & Degree
Annmarie Wacha-Montes, PsyD
First Name & Middle Initial & Last Name & Degree
Kate H Bentley, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
E-Manage: A Brief mHelath Intervention for University Students
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