College Mental Health Project

Depression is common and debilitating disorder which, among college students, is predictive of significant problems including higher rates of dropout and suicidal behaviors. Despite viable psychotherapeutic and pharmacological options, the majority of depressed college students, like others in the general population, do not pursue treatment. Further, barriers to care, both those involving practical issues and psychological factors, lead to high attrition rates from treatment, resulting in modest effect sizes in effectiveness trials. In reaction to these alarming figures and as a means of increasing accessibility and retention, effective internet-based treatment for depression have been developed and tested. Despite increased availability, response to internet-based treatment continues to vary substantially, yet, controlled trials show that a meaningful proportion of patients who receive internet-based therapy recover. Identifying individuals with a high likelihood of responding to internet-based treatment would enable clinicians to target this inexpensive treatment only to the patients with a high probability of responding; allowing more intensive treatments to be reserved for patients who would not respond to internet-based therapy. The development of a system to make this determination would represent a major advance and address an unmet need.

ICare is an online depression treatment that has been adapted for college students (e.g., language used, problems discussed, embedded images). Prior work by the developers of ICare have tested the internet-based treatment in diverse samples of depressed adults, and prior meta-analytic research has demonstrated that psychological treatments for depression in college students are as effective relative to trials carried out among depressed adults. The overarching goal of the study is to: (a) test whether depressed college students utilize ICare, (b) identify psychosocial and clinical characteristics that increase the likelihood of ICare utilization, and (c) identify multivariate characteristics that predict treatment response.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Other: ICare Prevent (internet-based treatment for depression in college students)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Randy P Auerbach, PhD; Phone Number: 617-855-4405; Email: rauerbach@mclean.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Recruiting
      • McLean Hospital
      • Contact: Randy P Auerbach, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 18-25 years;
• Enrolled as a first year student at a participating institution;
• English fluency;
• Mild or Moderate Depression: (i) PHQ-9 score 10-14 or (ii) PHQ-9 score 15-19;
• Provide Online Consent Form.

Exclusion Criteria:

• Severe Depression: (i) PHQ-9 score ≥20;
• Endorse "3" (nearly every day) on item 9 of the PHQ-9;
• No internet access

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-Based Treatment (ICare); ICare Prevent is a 7-week internet-based treatment for depression that is primarily cognitive behavior therapy but targets broad-based mechanisms related to college students.	Other: ICare Prevent (internet-based treatment for depression in college students); ICare Prevent (internet-based treatment for depression in college students): 7 weekly sessions and 1 booster session. Each session requires about 30-45 minutes to complete. All sessions are accessed online, and it is a guided treatment (i.e., each patient provided an eCoach).
No Intervention: Usual Care; Participants are notified that they have elevated distress, and additionally, they are provided a list of on-campus and community resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9) administered at post-treatment	Self-report questionnaire assessing depression symptoms during the past 2 weeks. Scores on the PHQ-9 range from 0-27. Lower scores are indicative of less severe depressive symptoms.	Assess depressive symptoms over the prior 2 weeks.
Generalized Anxiety Disorder - 7 item (GAD-7) administered at post-treatment	Self-report questionnaire assessing anxiety symptoms during the past 2 weeks. Scores on the GAD-7 range from 0-21. Lower scores are indicative of less severe anxious symptoms.	Assess anxious symptoms over the prior 2 weeks.
EuroQol 5 (EQ-5D) administered at post-treatment	Comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 items is rated on a scale from 1 to 3, and then summed to a total score. Lower scores are indicative of less severe problems.	Examines problems/symptoms over the prior 2 weeks.

Collaborators and Investigators

• Sponsor: Mclean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Internet-based treatment
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2016P002625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No