College Mental Health Project

Tracking Information
First Submitted Date ICMJE	November 3, 2017
First Posted Date ICMJE	November 17, 2017
Last Update Posted Date	August 17, 2018
Actual Study Start Date ICMJE	April 1, 2018
Estimated Primary Completion Date	October 30, 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 15, 2017)	Patient Health Questionnaire-9 (PHQ-9) administered at post-treatment [ Time Frame: Assess depressive symptoms over the prior 2 weeks. ]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.; Generalized Anxiety Disorder - 7 item (GAD-7) administered at post-treatment [ Time Frame: Assess anxious symptoms over the prior 2 weeks. ]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.; EuroQol 5 (EQ-5D) administered at post-treatment [ Time Frame: Examines problems/symptoms over the prior 2 weeks. ]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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT03345459 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	College Mental Health Project
Official Title ICMJE	College Mental Health Project
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Intervention Model Description: Participants are randomized to internet-based treatment (two-thirds of sample) or usual care (one-third of sample). Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Depression
Intervention ICMJE	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).
Study Arms	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. Intervention: Other: ICare Prevent (internet-based treatment for depression in college students); 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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: November 15, 2017)	200
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	January 1, 2020
Estimated Primary Completion Date	October 30, 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 25 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Randy P Auerbach, PhD 617-855-4405 rauerbach@mclean.harvard.edu
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT03345459
Other Study ID Numbers ICMJE	2016P002625
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Randy P. Auerbach, Mclean Hospital
Study Sponsor ICMJE	Mclean Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Mclean Hospital
Verification Date	March 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP