IntelliCare in College Students - Implementation (ICCS-I)

NCT04108429 | Completed Results DMC

• 2 other identifiers: K08MH112878-IETK08MH112878
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a hybrid effectiveness-implementation trial of the smartphone student stress-management app IntelliCare for college students. This intervention will be tested with University of Illinois at Chicago (UIC) and Northern Illinois University (NIU) students. During the study, participants will complete measures of depressive and anxious symptoms, as well as measures of mental health literacy, within the app.

Conditions

Depression; Anxiety

Keywords

Mental health; App; Mobile phone; Stress management

Outcome Measures

Primary Outcomes (4)

• Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module

  The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe

  Weekly symptom reports at Weeks 1, 2, 4, 6 and 8

• Generalized Anxiety Disorder Scale - 7 (GAD-7)

  The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity. GAD-7 total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome. Specifically, scores of 1-4 indicate minimal anxiety symptoms; 5-9 is mild anxiety symptoms; 10-14 is moderate anxiety symptoms; and 15-21 is severe anxiety symptoms.

  Weekly symptom reports at Weeks 1, 2, 4, 6 and 8

• Counseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)

  Counseling session utilization data were examined on a biweekly basis to determine if the introduction of the IntelliCare for College Students program impacts counseling center utilization. Counts of types of sessions (e.g. intake appointments, individual counseling appointments, crisis appointments) attended by students were examined over time to look at potential changes. These data were collected from the university in aggregate, thus, there are not participant-level data.

  Biweekly session utilization from August 1, 2018 (start of pre-implementation data collection; prior to the implementation trial) to December 18, 2020 (end of implementation period)

• Average Number of Days of App Usage

  The mean number of days the app was used was drawn from the study app over the course of the study

  Days of app use through study completion, up to 10 months

Secondary Outcomes (3)

• Anxiety Literacy Questionnaire

  Monthly questionnaire scores at baseline, one month and two months

• Depression Literacy Questionnaire

  Monthly questionnaire scores at baseline, one month and two months

• Cognitive and Behavioral Response to Stress Scale (CB-RSS)

  Monthly questionnaire scores at baseline, one month and two months

Study Arms (1)

Mobile self-help intervention

EXPERIMENTAL

Participants will have open access to the IntelliCare system.

Behavioral: IntelliCare for College Students

Interventions

IntelliCare for College Students BEHAVIORAL

Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day

Mobile self-help intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is a student at the University of Illinois in Chicago or Northern Illinois University. \*Participant owns a smartphone capable of running Android 7 (or higher) or iOS11 (or higher).
• Participant is 18 years of age or older

You may not qualify if:

• \*None

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60642, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being; Alzheimer Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Limitations and Caveats

Due to COVID-19-related changes and ongoing uncertainty surrounding operations on the university campuses with which we partnered, many of the program implementation plans were unable to be enacted. Due to the in-app nature of assessments, there was a high degree of data missingness on the mental health symptom data and the intervention target data.

Results Point of Contact

• Title: Dr. Emily Lattie
• Organization: Northwestern University

emily.lattie@northwestern.edu

312-503-5509

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Mobile self-help intervention

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 30, 2019
• Study Start: February 5, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: March 31, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)