DepressionNCT03345459
College Mental Health Project
A study testing ICare Prevent (internet-based treatment for depression in college students) in people with Depression, run by Mclean Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Depression
- What is being tested?
- ICare Prevent (internet-based treatment for depression in college students)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Severe Depression: (i) PHQ-9 score ≥20;
- Endorse "3" (nearly every day) on item 9 of the PHQ-9;
- No internet access
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
Randy P Auerbach, PhD
About this study
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
- Being tested
- ICare Prevent (internet-based treatment for depression in college students)
- Keywords
- Internet-based treatment
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Examines problems/symptoms over the prior 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Apr 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to internet-based treatment (two-thirds of sample) or usual care (one-third of sample).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randy P. Auerbach, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345459
- Sponsor's protocol ID
- 2016P002625
- Status last verified
- Feb 2020
- First submitted
- 3 Nov 2017
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- College Mental Health Project
- ClinicalTrials.gov ID
- NCT03345459
- Acronym / sponsor ID
- 2016P002625
- Conditions
- Depression
- Keywords
- Internet-based treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to internet-based treatment (two-thirds of sample) or usual care (one-third of sample).
| Arm | Type | Receives |
|---|---|---|
| Internet-Based Treatment (ICare) | Experimental | Other: ICare Prevent (internet-based treatment for depression in college students)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. |
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Severe Depression: (i) PHQ-9 score ≥20;
- Endorse "3" (nearly every day) on item 9 of the PHQ-9;
- No internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Internet-Based Treatment (ICare) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICare Prevent (internet-based treatment for depression in college students) in people with Depression, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Randy P Auerbach, PhD (617-855-4405, rauerbach@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) administered at post-treatment (time frame: Assess depressive symptoms over the prior 2 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.