College Mental Health Project

NCT03345459 | Unknown

• 1 other identifier: 2016P002625
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Internet-based treatment

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Internet-Based Treatment (ICare)

EXPERIMENTAL

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)

Usual Care

NO INTERVENTION

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

Interventions

ICare Prevent (internet-based treatment for depression in college students) OTHER

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).

Internet-Based Treatment (ICare)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Randy P Auerbach, PhD

CONTACT

617-855-4405; rauerbach@mclean.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Participants are randomized to internet-based treatment (two-thirds of sample) or usual care (one-third of sample).

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 17, 2017
• Study Start: April 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: January 1, 2022
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)