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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01228890
Date of registration: 25/10/2010
Prospective Registration: No
Primary sponsor: University of Chicago
Public title: Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT) CATCH-IT
Scientific title: Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
Date of first enrolment: September 2010
Target sample size: 0
Recruitment status: Withdrawn
URL:  http://clinicaltrials.gov/show/NCT01228890
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Benjamin Van Voorhees, MD
Address: 
Telephone:
Email:
Affiliation:  University of Chicago
Key inclusion & exclusion 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).



Age minimum: 13 Years
Age maximum: 17 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Externalizing Symptoms
Substance Abuse
Anxiety
Depression
Intervention(s)
Behavioral: CATCH-IT
Behavioral: AMPE
Primary Outcome(s)
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]
Secondary Outcome(s)
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]
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]
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]
Secondary ID(s)
10-464-A
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Harvard Vanguard Medical Associates
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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