IntelliCare in College Students

NCT04035577 | Completed Results DMC

• 2 other identifiers: K08MH112878-EUTK08MH112878
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an 8-week usability and feasibility 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 this period, research surveys assessing depression and anxiety can be completed on the app. Also, user feedback interviews will be conducted viatelephone at four weeks and at eight weeks to gain insight on the user experience of IntelliCare for College Students.

Conditions

Depression; Anxiety

Keywords

Mental health; App; Mobile phone; Stress management

Outcome Measures

Primary Outcomes (10)

• Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module

  The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-8 is 0-24. 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 20-24 is severe.

  Week 4

• Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module

  The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-24. 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 20-24 is severe.

  Week 8

• GAD-7 (Generalized Anxiety Disorder Scale-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.

  Week 4

• GAD-7 (Generalized Anxiety Disorder Scale-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.

  Week 8

• Anxiety Literacy Questionnaire

  This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.

  Week 4

• Anxiety Literacy Questionnaire

  This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.

  Week 8

• Depression Literacy Questionnaire

  This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy

  Week 4

• Depression Literacy Questionnaire

  This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy

  Week 8

• Cognitive and Behavioral Response to Stress Scale

  This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills. There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness. For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g. "During the past month, how often did you take a moment to notice things that made you feel good or grateful? How helpful was this in making you feel better?"). Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30. Higher scores indicate better outcomes.

  Week 4

• The Cognitive and Behavioral Response to Stress Scale

  This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills. There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness. For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g. "During the past month, how often did you take a moment to notice things that made you feel good or grateful? How helpful was this in making you feel better?"). Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30. Higher scores indicate better outcomes.

  Week 8

Secondary Outcomes (1)

• Mean Number of Treatment App Use Sessions

  Daily for two months

Study Arms (1)

Extended usability of a mobile self-help intervention

EXPERIMENTAL

Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks

Behavioral: Mobile self-help intervention

Interventions

Mobile self-help intervention BEHAVIORAL

During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8. All participants will first undergo initial assessments that will include a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of 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

Extended usability of a 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, 60611, United States

Location

Related Publications (1)

• Lattie E, Cohen KA, Winquist N, Mohr DC. Examining an App-Based Mental Health Self-Care Program, IntelliCare for College Students: Single-Arm Pilot Study. JMIR Ment Health. 2020 Oct 10;7(10):e21075. doi: 10.2196/21075.

  PMID: 33037874 DERIVED

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

Results Point of Contact

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

emily.lattie@northwestern.edu

3125033741

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: July 23, 2019
• First Posted: July 29, 2019
• Study Start: July 8, 2019
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

US (1)