Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)

Depression Clinical Trial

— CATCH-IT  

Official title:

Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01228890
• Other study ID #: 10-464-A
• Status: Withdrawn
• Phase: Phase 3
• First received: October 25, 2010
• Last updated: December 13, 2012
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: December 2012
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In this 5-year, two-site randomized clinical trial, we propose to test the efficacy of the CATCH-IT primary care/Internet based depression prevention intervention against Attention Monitoring Psychoeducation (AMPE) in preventing the onset of depressive episodes in an intermediate to high risk group of adolescents aged 13-17. We plan to (a) identify high risk adolescents based on elevated scores on the PHQ-A, a screening measure of depressive symptoms; (b) recruit 400 (200 per site) of these at-risk adolescents to be randomized into either the CATCH-IT or the AMPE group; (c) assess outcomes at 2, 8, 12, 18, and 24 months post intake on measures of depressive symptoms, depressive diagnoses, other mental disorders, and on measures of role impairment in education, quality of life, attainment of educational milestones, and family functioning; and (d) conduct exploratory analyses to examine the effectiveness of this intervention program, moderators of protection, and potential ethnic and cultural differences in intervention response.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• Youth ages 13 through 17.

• Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression46 (CES-D) scale (score >/= 16) and have at least two core symptoms of Major Depression on the Patient Health Questionnaire, Adolescents.

• Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse.

Exclusion Criteria:

• Current DSM-IV diagnosis (Kiddie Schedule of Affective Disorders) of Major Depressive Disorder, current therapy for depression, or be taking antidepressants (e.g., SSRIs, TCAs, MAOIs, bupropion, nefazodone, mirtazapine, venlafaxine).

• Current CES-D score >35

• DSM-IV diagnosis of schizophrenia (current or past) or bipolar affective disorder

• Current serious medical illness that causes significant disability or dysfunction

• Significant reading impairment (a minimum sixth-grade reading level based on parental report), mental retardation, or developmental disabilities

• Serious imminent suicidal risk (as determined by endorsement of current suicidality on CES-D or in KSADS interview) or other conditions that may require immediate psychiatric hospitalization

• Psychotic features or disorders, or currently be receiving psychotropic medication

• Extreme, current drug/alcohol abuse (greater than or equal to 2 on the CRAFFT).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Disorder
• Externalizing Symptoms
• Substance Abuse

Intervention

Behavioral:
• CATCH-IT
The CATCH-IT 2-R intervention has a motivational (3 PCP motivational interviews at time 0, 1.5 months and 12 months and 3 coaching phone calls at 2 and 4 weeks and 18 months) and an Internet component (with separate adolescent [14 modules] and parent [5 modules] programs). This revised and expanded intervention will include a comprehensive approach to reducing modifiable risk factors and enhancing resiliency factors associated with increased or decreased risk of depression, respectively, proposed by Spence and Reinecke.148 The revised CATCH-IT "Tracker" will monitor time in study and deploy elements of the intervention based on time since enrollment, including computer and human elements (e.g. calls, doctor visits).
• AMPE
The AMPE components are similar to those employed in previous primary care based quality improvement/Chronic Care Model Interventions (patient education [psycho-education described below], provider training [described in Case Finding and Recruitment], active monitoring and referral [case management, discussed under assessments], physician and nurse education and routine contact with PCP [study design rationale]). This Internet site will focus on assisting parents and adolescents in early identification of need for treatment and will also target stigma and negative attitudes toward treatment of mental disorders we have previously identified as barriers to seeking and adhering to treatment.

Locations

Country	Name	City	State
United States	Harvard Vanguard Medical Associates	Boston	Massachusetts
United States	Access Community Health Network	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Northshore University Health Systems	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Harvard Vanguard Medical Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether the CATCH-IT 2-R depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to AMPE.		49-60 months from beginning of trial	No
Secondary	To determine if participants in the CATCH-IT 2-R group exhibit more rapid favorable changes of depressive symptoms/and or vulnerability/protective factors compared with the AMPE group.		49-60 months from beginning of the trial	No
Secondary	To determine if participants in the CATCH-IT 2-R program report lower perceived educational impairment, greater quality of life, greater health-related quality of life, and lower incidence of other mental disorders (anxiety, substance/alcohol use).		49-60 months from beginning of trial	No
Secondary	To determine for whom (moderators) and how (mediators) the CATCH-IT 2-R program works in this population.		49-60 months from beginning of trial	No