Chicago Urban Resiliency Building (CURB)

Major Depression Clinical Trial

— CURB  

Official title:

Chicago Urban Resiliency Building (CURB): Phase 3 Clinical Trial in Primary Care to Engage Adolescents With a Web-based Depression Prevention Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571011
• Other study ID #: RWJF 68177
• Status: Completed
• Phase: N/A
• First received: March 20, 2012
• Last updated: July 31, 2015
• Start date: March 2012
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

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):

• Physician at one of the four Mile Square Health Centers.

Health Care Professionals:

• Employee at one of the four Mile Square Health Centers.

Exclusion Criteria:

• 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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Major
• Major Depression

Intervention

Behavioral:
• CURB
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.

Locations

Country	Name	City	State
United States	Mile Square Health Centers	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Benjamin Van Voorhees, MD, MPH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0, 3, 6 months	Yes
Secondary	Cost effective outcome measures		6 months	No
Secondary	Vulnerability		6 months	No
Secondary	Protective factors		6 months	No

External Links

•   Sponsor