NCT01893749

Brief Summary

The purpose of this randomized multiple-site clinical study is to determine whether a revised CATCH-IT (Internet-based depression prevention program) is more effective than a general health education Internet intervention (Health Education)on teens ages 13-18 (inclusive). It is hypothesized that teens in CATCH-IT will exhibit lower levels of depressed mood and/or maintain lower depressive scores over 2 years long-term follow up as compared to teens in Health Education group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,142

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

4.4 years

First QC Date

June 5, 2012

Last Update Submit

August 19, 2019

Conditions

Major DepressionDepressive Episodes

Keywords

depressionpreventionteenat riskinternet

Outcome Measures

Primary Outcomes (1)

  • Major Depressive Episode (major and sub-threshold)

    Kiddie Schedule of Affective Disorders Scale (KSADS) used to evaluate for current and past depressive episode at each time point (interval between time points). Occurrence of first depressive episode was determined by the Depression Symptom Rating (DSR). We considered a score indicating at least sub-threshold major depression (a DSR of ≥3+) to be a depressive episode. DSR 4 and above and 5 alone will also be assessed.

    0, 2, 6, 12, 18 and 24 months

Secondary Outcomes (3)

  • Depressed mood

    0, 2, 6, 12, 24 months

  • Vulnerability Factors

    0, 2, 6, 12, 18, 24 months

  • Quality of Life, educational impairment and other mental disorder symptoms or episodes

    0, 2, 6, 12, 18, 24 months

Other Outcomes (4)

  • Adherence to Internet Use

    continous measure

  • Implementation

    0, 2, 24 months

  • Motivation (adolescent)

    0,2,12 months

  • +1 more other outcomes

Study Arms (2)

CATCH-IT

EXPERIMENTAL

200 randomized teens 13-18 year old (inclusive) will be enrolled into the online program that contains 14 modules focused various therapeutic techniques, a booster session of 6 modules at the end of the online program and three 15 minute visits with their primary care doctor to discuss the benefits and disadvantages of the program. Parents will also be invited to participant in a partnering online program involving 4 modules online and 1 optional module. They will be asked to then participate in three 15 minute interviews with a member of the study team to discuss the benefits and disadvantages of the program.

Behavioral: CATCH-IT

Health Education

NO INTERVENTION

200 randomized teens, ages 13-18 year old (inclusive) receiving an online program with 14 modules that focus on general health education, depression, diet, exercise, hygiene and safety. Parents will also be invited to participate in an online program with 4 modules that also focus on general health education.

Interventions

CATCH-ITBEHAVIORAL

It contains 14 modules focused on behavioral activation, cognitive behavioral therapy, interpersonal therapy and a resiliency building model, including elements such as narratives, video diaries, skill building exercises and a booster program (not yet initiated) with 6 modules that involves interaction with a live therapist. It also includes three 15-minute meetings with the primary care provider at baseline, 2 months and 12 months post intervention. These meetings are focused on the motivational interview approach where the patient and the doctor talk about the mental/physical health goals of the patient and determine the best approach for the patient by allowing the patient to have full input into the plan.

Also known as: CATCH-IT 2, CATCH-IT 3
CATCH-IT

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents:
  • (A) Youth ages 13 through 18 who are English speaking. (B) Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression (CES-D) scale (score \>/= 16). (C) Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse. Youth presenting in partial remission from a major depressive episode at Baseline will be rescreened after 2 months utilizing the phone screen to ensure episode is fully remitted prior to randomization or access to study intervention. Those who do not fully remit after two months will be excluded.
  • Parents:
  • \*Parent of eligible adolescents
  • Physicians (PCP) or NP:
  • \*Physician in any of the study sites
  • Healthcare Professionals:
  • \*Primary care practice for a minimum of 6 months

You may not qualify if:

  • Adolescents:
  • Current DSM-IV diagnosis 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 suicide 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).
  • Parents:
  • Ineligible child
  • Non-English speaking
  • Physicians:
  • \*None
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

ACCESS Healthcare Systems

Chicago, Illinois, 60606, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Northshore Healthcare Systems

Evanston, Illinois, 60201, United States

Location

Advocate Health Care

Oak Lawn, Illinois, 60453, United States

Location

Children's Clinic

Oak Park, Illinois, 60302, United States

Location

Franciscan St. Margaret Health

Dyer, Indiana, 46311, United States

Location

Wellesley Center for Women

Wellesley, Massachusetts, 02481-8203, United States

Location

Related Publications (3)

  • Van Voorhees B, Gladstone TRG, Sobowale K, Brown CH, Aaby DA, Terrizzi DA, Canel J, Ching E, Berry AD, Cantorna J, Eder M, Beardslee W, Fitzgibbon M, Marko-Holguin M, Schiffer L, Lee M, de Forest SA, Sykes EE, Suor JH, Crawford TJ, Burkhouse KL, Goodwin BC, Bell C. 24-Month Outcomes of Primary Care Web-Based Depression Prevention Intervention in Adolescents: Randomized Clinical Trial. J Med Internet Res. 2020 Oct 28;22(10):e16802. doi: 10.2196/16802.

    PMID: 33112254DERIVED

  • Gladstone T, Buchholz KR, Fitzgibbon M, Schiffer L, Lee M, Voorhees BWV. Randomized Clinical Trial of an Internet-Based Adolescent Depression Prevention Intervention in Primary Care: Internalizing Symptom Outcomes. Int J Environ Res Public Health. 2020 Oct 22;17(21):7736. doi: 10.3390/ijerph17217736.

    PMID: 33105889DERIVED

  • Gladstone TG, Marko-Holguin M, Rothberg P, Nidetz J, Diehl A, DeFrino DT, Harris M, Ching E, Eder M, Canel J, Bell C, Beardslee WR, Brown CH, Griffiths K, Van Voorhees BW. An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial. Trials. 2015 May 1;16:203. doi: 10.1186/s13063-015-0705-2.

    PMID: 25927539DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Benjamin Van Voorhees, MD, MPH

    UIC

    PRINCIPAL INVESTIGATOR

  • Tracy Gladstone, PHD

    Wellesley Center for Women

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine, Chief, Section of General Pediatrics and Adolescent Medicine, TIKES Center Director

Study Record Dates

First Submitted

June 5, 2012

First Posted

July 9, 2013

Study Start

February 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 22, 2019

Record last verified: 2019-08

Locations

US(7)