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

This study has been withdrawn prior to enrollment.
(no one enrolled; PI left institution)
Sponsor:
Collaborator:
Harvard Vanguard Medical Associates
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01228890
First received: October 25, 2010
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Depression
Anxiety
Externalizing Symptoms
Substance Abuse
Behavioral: CATCH-IT
Behavioral: AMPE
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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. [ Time Frame: 49-60 months from beginning of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 49-60 months from beginning of the trial ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 49-60 months from beginning of trial ] [ Designated as safety issue: No ]
  • To determine for whom (moderators) and how (mediators) the CATCH-IT 2-R program works in this population. [ Time Frame: 49-60 months from beginning of trial ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CATCH-IT 2-R Arm
Primary care/Internet based depression prevention intervention (CATCH-IT 2-R) with a family component.
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).
Active Comparator: Attention Monitoring Psycho-education (AMPE) Arm Behavioral: 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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228890

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Access Community Health Network
Chicago, Illinois, United States
Northshore University Health Systems
Evanston, Illinois, United States
United States, Massachusetts
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States
Sponsors and Collaborators
University of Chicago
Harvard Vanguard Medical Associates
Investigators
Principal Investigator: Benjamin Van Voorhees, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01228890     History of Changes
Other Study ID Numbers: 10-464-A
Study First Received: October 25, 2010
Last Updated: December 13, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014