Recruiting

Observational Study

Sponsor:

Mclean Hospital

Code:

NCT03345459

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT03345459

Start date

Apr 1, 2018

Status verified date

Feb, 2020

Completion date

Jan 1, 2022

Anticipated

Primary completion date

Dec 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

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).

Primary outcome measure

  • Patient Health Questionnaire-9 (PHQ-9) administered at post-treatment [ Time Frame: Assess depressive symptoms over the prior 2 weeks. ]
  • Generalized Anxiety Disorder - 7 item (GAD-7) administered at post-treatment [ Time Frame: Assess anxious symptoms over the prior 2 weeks. ]
  • EuroQol 5 (EQ-5D) administered at post-treatment [ Time Frame: Examines problems/symptoms over the prior 2 weeks. ]

Central Contacts and Locations

Central contacts

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

More Information

Sponsor

Mclean Hospital

Last update posted

Feb 24, 2020

Last verified

Feb, 2020

Keywords

  • Internet-based treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2020-02-24.