Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01228890 |
Date of registration:
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25/10/2010 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
CATCH-IT |
Scientific title:
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Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT) |
Date of first enrolment:
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September 2010 |
Target sample size:
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0 |
Recruitment status: |
Withdrawn |
URL:
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http://clinicaltrials.gov/show/NCT01228890 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Benjamin Van Voorhees, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Chicago |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Externalizing Symptoms
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Substance Abuse
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Anxiety
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Depression
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Intervention(s)
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Behavioral: CATCH-IT
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Behavioral: AMPE
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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