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College Mental Health Project

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ICare Prevent (internet-based treatment for depression in college students)
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Internet-based treatment

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McLean HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-Based Treatment (ICare)

Usual Care

Arm Description

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.

Participants are notified that they have elevated distress, and additionally, they are provided a list of on-campus and community resources.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2017
Last Updated
February 21, 2020
Sponsor
Mclean Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03345459
Brief Title
College Mental Health Project
Official Title
College Mental Health Project
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Internet-based treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to internet-based treatment (two-thirds of sample) or usual care (one-third of sample).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internet-Based Treatment (ICare)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants are notified that they have elevated distress, and additionally, they are provided a list of on-campus and community resources.
Intervention Type
Other
Intervention Name(s)
ICare Prevent (internet-based treatment for depression in college students)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9) administered at post-treatment
Description
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.
Time Frame
Assess depressive symptoms over the prior 2 weeks.
Title
Generalized Anxiety Disorder - 7 item (GAD-7) administered at post-treatment
Description
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.
Time Frame
Assess anxious symptoms over the prior 2 weeks.
Title
EuroQol 5 (EQ-5D) administered at post-treatment
Description
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.
Time Frame
Examines problems/symptoms over the prior 2 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randy P Auerbach, PhD
Phone
617-855-4405
Email
rauerbach@mclean.harvard.edu
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randy P Auerbach, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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