Primary Care Internet Based Depression Prevention for Adolescents (CATCH-IT) Also Known as Promoting AdolescenT Health

NCT ID: NCT01893749

Last Updated: 2019-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Additional aims and hypothesis are provided below:

-Aim 1: To determine whether the CATCH-IT depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to HEALTH EDUCATION.

Hypothesis 1: Compared to youth in the HEALTH EDUCATION condition, youth assigned to CATCH-IT will have a lower hazard ratio of major depressive episodes and non-affective disorder episodes over 2 years.

-Aim 2: To determine if participants in the CATCH-IT group exhibit more rapid favorable changes of depressive symptoms/and or vulnerability/protective factors compared to the HEALTH EDUCATION group.

Hypothesis 2: Compared to youth in the HEALTH EDUCATION condition, youth in the CATCH-IT program will demonstrate a steeper slope of improved symptoms and fewer depressed days over 2 years.

-Aim 3: To determine if participants in the CATCH-IT 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) as compared to participants in HEALTH EDUCATION.

Hypothesis 3: Compared to youth in the HEALTH EDUCATION group, youth in the CATCH-IT program will demonstrate more rapid benefits in reduced educational impairment, improved quality of life, and fewer disorders over 2 years.

-Aim 4: To determine for whom (moderators)among 13-18 year old (inclusive) and how (mediators) the CATCH-IT program works.

Hypothesis 4.1: CATCH-IT effects will be moderated by six domains: (1) demographic/cultural factors, (2) vulnerability factors/adverse events,(3) motivation,(4) physician relationship, (5) parent/child co-morbid psychopathology, and (6) treatment.

Hypothesis 4.2: The relation between CATCH-IT participation and reduction in depressive episodes will be mediated by adherence to the Internet, motivational interview fidelity as they alter vulnerability factors (e.g. motivation, cognition and social support) and responses to adverse events, which in turn impact the likelihood of episodes.

Exploratory Aim 1: To determine the implementation feasibility of the intervention from the physician/nurse practitioner and office nurse/medical assistant perspective as well as to describe the practices in relationship to the medical home model.

Exploratory Aim 2: To determine whether CATCH-IT has a favorable cost-benefit ratio and/or cost effectiveness of \<$50,000/disability adjusted life year compared to the HEALTH EDUCATION group.

Conditions

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Major Depression Depressive Episodes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CATCH-IT

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.

Group Type EXPERIMENTAL

CATCH-IT

Intervention Type BEHAVIORAL

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.

Health Education

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CATCH-IT

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CATCH-IT 2 CATCH-IT 3

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Healthcare Professionals:

\*None
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wellesley College

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

Harvard Vanguard Medical Associates

OTHER

Sponsor Role collaborator

Access Healthcare Systems

OTHER

Sponsor Role collaborator

Endeavor Health

OTHER

Sponsor Role collaborator

Infant Welfare Society

UNKNOWN

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

Franciscan St. Margaret Health - Franciscan Alliance

UNKNOWN

Sponsor Role collaborator

Benjamin Van Voorhees, MD, MPH

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Van Voorhees, MD, MPH

Associate Professor of Medicine, Chief, Section of General Pediatrics and Adolescent Medicine, TIKES Center Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Benjamin Van Voorhees, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UIC

Tracy Gladstone, PHD

Role: PRINCIPAL_INVESTIGATOR

Wellesley Center for Women

Locations

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ACCESS Healthcare Systems

Chicago, Illinois, United States

Site Status

University of Illinois

Chicago, Illinois, United States

Site Status

Northshore Healthcare Systems

Evanston, Illinois, United States

Site Status

Advocate Health Care

Oak Lawn, Illinois, United States

Site Status

Children's Clinic

Oak Park, Illinois, United States

Site Status

Franciscan St. Margaret Health

Dyer, Indiana, United States

Site Status

Wellesley Center for Women

Wellesley, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33112254 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33105889 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25927539 (View on PubMed)

Other Identifiers

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1R01MH090035-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011-0505

Identifier Type: -

Identifier Source: org_study_id

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