Major DepressionCURBNCT01571011
Chicago Urban Resiliency Building (CURB)
A study testing CURB in people with Major Depression, run by Benjamin Van Voorhees, MD, MPH at 1 site in United States.
Trial summary
The purpose of the study is to determine whether a culturally tailored, low-cost, primary care/internet based depression prevention intervention (CURB) is superior to wait-list control for African American and Hispanic youth in terms of depression-related outcomes. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- What is being tested?
- CURB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Apr 2014
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents:
- Male and female African American and Latino/a youth ages 13 -17 years old.
- Adolescents with depressed mood (> 2 weeks duration) will be eligible unless they have already exceeded the diagnostic threshold for major depressive disorder or have a comorbid condition as defined in the exclusion criteria.
- Parents:
- Parent of eligible adolescents
- Primary Care Physicians (PCPs):
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- Physician at one of the four Mile Square Health Centers.
- Health Care Professionals:
- Employee at one of the four Mile Square Health Centers.
Who cannot join
- Adolescents undergoing active treatment for depression [Active treatment for depression is defined as receiving anti-depressant medication or counseling within one year of remission of symptoms from the most recent episode]
- Adolescents meeting probable diagnostic criteria for the following: Major depression, Substance and alcohol abuse, Panic attacks, Generalized anxiety disorder, Eating disorders, History of treatment for bi-polar disorder or schizophrenia or who are at elevated risk for suicide (often have suicidal thoughts or recent intent)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chicago Urban Resiliency Building (CURB): Phase 3 Clinical Trial in Primary Care to Engage Adolescents With a Web-based Depression Prevention Intervention
The purpose of the study is to determine whether a culturally tailored, low-cost, primary care/internet based depression prevention intervention (CURB) is superior to wait-list control for African American and Hispanic youth in terms of depression-related outcomes. It is hypothesized that compared to teens in the wait-list control condition, teens in the CURB program will exhibit lower levels of depressed mood and/or more rapid changes in mood during the follow-up time.
Read the detailed description
Additional aims and hypotheses are provided here:
Aim 2: To determine whether or not participants in the CURB primary care/Internet based depression prevention intervention will have a significantly lower cumulative incidence of any depressive episode at 3 months compared to adolescents in the usual care wait-list group.
Hypothesis 2: Compared to youth in the wait-list control condition, youth in the CURB program will have a lower incidence of depressive episodes at 6 month follow-up.
Aim 3: To determine whether CURB is sustainable in primary care from the perspective of health care professionals and primary care physicians in urban primary care settings.
Hypothesis 3: We hypothesize that providers will rate the intervention (by component) feasibility, acceptability, willingness to perform intervention and sustainability > 7 on a 1-10 scale (1, not feasible, 10 very feasible).
- Conditions
- Major Depression
- Being tested
- CURB
- Keywords
- Adolescent, Randomized Trial, Internet, Depressive Disorder, Primary Care, Prevention
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CURBBehavioural
The intervention is made up of 14 internet modules based on behavioral activation, cognitive behavioral therapy, and interpersonal psychotherapy as well as motivational interviews in the primary care setting (to enhance behavior change). It is suggested that an adolescent navigates through 2 modules a week. The motivational interviews with the physicians occur directly before and after the adolescent is exposed to the website (at baseline and 3 months) in the providers office. The parents of the enrolled adolescents are also invited to navigate through their own, 3 module, parent internet program.
| Study group | Role | What they receive |
|---|---|---|
| CURB Intervention | Experimental | The intervention is made up of 14 internet modules based on behavioral activation, cognitive behavioral therapy, and interpersonal psychotherapy as well as motivational interviews in the primary care setting (to enhance behavior change). It is suggested that an adolescent navigates through 2 modules a week. The motivational interviews with the physicians occur directly before and after the adolescent is exposed to the website (at baseline and 3 months) in the providers office. The parents of the enrolled adolescents are also invited to navigate through their own, 3 module, parent internet program. Receives: Behavioral: CURB |
| CURB Intervention (Wait List) | Experimental | Same as the CURB Intervention arm, however, individuals assigned to this arm wait 3 months before receiving the intervention. Receives: Behavioral: CURB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Center for Epidemiological Studies of Depression (CES-D) Scale
Change in CESD from baseline Change in CESD scale between and within groups across the 6 months and for each assessment point
Measured: 0, 3, 6 months
Secondary outcomes (3)
Cost effective outcome measures
Measured: 6 months
Vulnerability
Measured: 6 months
Protective factors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benjamin Van Voorhees, MD, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benjamin Van Voorhees, MD, MPH, University of Illinois Chicago
- Investigators
- Benjamin Van Voorhees, MD, MPH, Principal investigator, University of Illinois ChicagoMonika Marko, MSS, Study director, UIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571011
- Sponsor's protocol ID
- RWJF 68177
- Acronym
- CURB
- Status last verified
- Jul 2015
- First submitted
- 20 Mar 2012
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chicago Urban Resiliency Building (CURB): Phase 3 Clinical Trial in Primary Care to Engage Adolescents With a Web-based Depression Prevention Intervention
- ClinicalTrials.gov ID
- NCT01571011
- Acronym / sponsor ID
- CURB / RWJF 68177
- Conditions
- Major Depression
- Keywords
- Adolescent, Randomized Trial, Internet, Depressive Disorder, Primary Care, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Benjamin Van Voorhees, MD, MPHUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Apr 2012 (estimated)
- 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.
The purpose of the study is to determine whether a culturally tailored, low-cost, primary care/internet based depression prevention intervention (CURB) is superior to wait-list control for African American and Hispanic youth in terms of depression-related outcomes. It is hypothesized that compared to teens in the wait-list control condition, teens in the CURB program will exhibit lower levels of depressed mood and/or more rapid changes in mood during the follow-up time.
Detailed description
Additional aims and hypotheses are provided here:
Aim 2: To determine whether or not participants in the CURB primary care/Internet based depression prevention intervention will have a significantly lower cumulative incidence of any depressive episode at 3 months compared to adolescents in the usual care wait-list group.
Hypothesis 2: Compared to youth in the wait-list control condition, youth in the CURB program will have a lower incidence of depressive episodes at 6 month follow-up.
Aim 3: To determine whether CURB is sustainable in primary care from the perspective of health care professionals and primary care physicians in urban primary care settings.
Hypothesis 3: We hypothesize that providers will rate the intervention (by component) feasibility, acceptability, willingness to perform intervention and sustainability > 7 on a 1-10 scale (1, not feasible, 10 very feasible).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CURB Intervention | Experimental | Behavioral: CURBThe intervention is made up of 14 internet modules based on behavioral activation, cognitive behavioral therapy, and interpersonal psychotherapy as well as motivational interviews in the primary care setting (to enhance behavior change). It is suggested that an adolescent navigates through 2 modules a week. The motivational interviews with the physicians occur directly before and after the adolescent is exposed to the website (at baseline and 3 months) in the providers office. The parents of the enrolled adolescents are also invited to navigate through their own, 3 module, parent internet program. |
| CURB Intervention (Wait List) | Experimental | Behavioral: CURBSame as the CURB Intervention arm, however, individuals assigned to this arm wait 3 months before receiving the intervention. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Male and female African American and Latino/a youth ages 13 -17 years old.
- Adolescents with depressed mood (> 2 weeks duration) will be eligible unless they have already exceeded the diagnostic threshold for major depressive disorder or have a comorbid condition as defined in the exclusion criteria.
- Parent of eligible adolescents
- Physician at one of the four Mile Square Health Centers.
- Employee at one of the four Mile Square Health Centers.
Key exclusion criteria (2 listed)
- Adolescents undergoing active treatment for depression [Active treatment for depression is defined as receiving anti-depressant medication or counseling within one year of remission of symptoms from the most recent episode]
- Adolescents meeting probable diagnostic criteria for the following: Major depression, Substance and alcohol abuse, Panic attacks, Generalized anxiety disorder, Eating disorders, History of treatment for bi-polar disorder or schizophrenia or who are at elevated risk for suicide (often have suicidal thoughts or recent intent)
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 |
|---|---|---|
| CURBThe intervention is made up of 14 internet modules based on behavioral activation, cognitive behavioral therapy, and interpersonal psychotherapy as well as motivational interviews in the primary care setting (to enhance behavior change). It is suggested that an adolescent navigates through 2 modules a week. The motivational interviews with the physicians occur directly before and after the adolescent is exposed to the website (at baseline and 3 months) in the providers office. The parents of the enrolled adolescents are also invited to navigate through their own, 3 module, parent internet program. | Behavioural | CURB Intervention, CURB Intervention (Wait List) |
Primary outcome
The Center for Epidemiological Studies of Depression (CES-D) Scale
Time frame: 0, 3, 6 months
Change in CESD from baseline Change in CESD scale between and within groups across the 6 months and for each assessment point
3 secondary outcomes
Cost effective outcome measures
Time frame: 6 months
Vulnerability
Time frame: 6 months
Protective factors
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- SponsorLink provided by the sponsor.
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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.
Benjamin Van Voorhees, MD, MPH principal investigator
University of Illinois Chicago
Monika Marko, MSS study director
UIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CURB in people with Major Depression, run by Benjamin Van Voorhees, MD, MPH 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 9 inclusion and 2 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: finished, as of the sponsor's last update on 4 Aug 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Center for Epidemiological Studies of Depression (CES-D) Scale (time frame: 0, 3, 6 months). 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 4 Aug 2015.