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College Mental Health Project

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ClinicalTrials.gov Identifier: NCT03345459
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Randy P. Auerbach, Mclean Hospital

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.


Condition or disease Intervention/treatment Phase
Depression Other: ICare Prevent (internet-based treatment for depression in college students) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Official Title: College Mental Health Project
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345459


Contacts
Contact: Randy P Auerbach, PhD 617-855-4405 rauerbach@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Randy P Auerbach, PhD         
Sponsors and Collaborators
Mclean Hospital

Responsible Party: Randy P. Auerbach, Director, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03345459     History of Changes
Other Study ID Numbers: 2016P002625
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Randy P. Auerbach, Mclean Hospital:
Internet-based treatment